Trial Outcomes & Findings for Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction (NCT NCT01781390)
NCT ID: NCT01781390
Last Updated: 2022-06-23
Results Overview
Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Up to approximately 8 years
Results posted on
2022-06-23
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
36
|
|
Overall Study
COMPLETED
|
32
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
|---|---|---|---|
|
Overall Study
Withdrawal of Consent
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
|
Overall Study
Participants who were Randomized and Not Treated
|
1
|
1
|
1
|
Baseline Characteristics
Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
n=34 Participants
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
n=35 Participants
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.79 • n=34 Participants
|
60.7 years
STANDARD_DEVIATION 13.11 • n=34 Participants
|
57.6 years
STANDARD_DEVIATION 12.12 • n=35 Participants
|
59.8 years
STANDARD_DEVIATION 11.76 • n=103 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
8 Participants
n=35 Participants
|
17 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=34 Participants
|
32 Participants
n=34 Participants
|
27 Participants
n=35 Participants
|
86 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=34 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=34 Participants
|
33 Participants
n=34 Participants
|
35 Participants
n=35 Participants
|
101 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=34 Participants
|
33 Participants
n=34 Participants
|
34 Participants
n=35 Participants
|
100 Participants
n=103 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=103 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=103 Participants
|
|
Left Ventricular (LV) End-systolic Volume (LVESV) as Assessed by Cardiac MRI
|
85.544 milliliter (ml)
STANDARD_DEVIATION 34.8935 • n=30 Participants • Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
|
91.728 milliliter (ml)
STANDARD_DEVIATION 30.4476 • n=28 Participants • Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
|
92.163 milliliter (ml)
STANDARD_DEVIATION 33.1251 • n=32 Participants • Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
|
89.821 milliliter (ml)
STANDARD_DEVIATION 32.7025 • n=90 Participants • Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
|
PRIMARY outcome
Timeframe: Up to approximately 8 yearsPopulation: The safety set included all participants who were randomly assigned to a treatment at screening and received treatment. Overall number analyzed is the participants available for analyses.
Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
n=34 Participants
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
n=35 Participants
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
28 Participants
|
30 Participants
|
31 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
14 Participants
|
16 Participants
|
14 Participants
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 26 other events
Deaths: 0 deaths
Mesenchymal Precursor Cells (MPC) 12.5 M
Serious events: 16 serious events
Other events: 33 other events
Deaths: 2 deaths
Mesenchymal Precursor Cells (MPC) 25 M
Serious events: 14 serious events
Other events: 31 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=34 participants at risk
Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 mins including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
n=34 participants at risk
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
n=35 participants at risk
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Angina pectoris
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Angina unstable
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Coronary artery disease
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Arteriospasm coronary
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Chest pain
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Diaphragmatic hernia gangrenous
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Migraine with aura
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Psychiatric disorders
Acute psychosis
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 mins including line flush \[0 Mesenchymal Precursor Cells (MPCs)/min\] on Day 0.
|
Mesenchymal Precursor Cells (MPC) 12.5 M
n=34 participants at risk
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (2.5x10\^5 MPCs/min) on Day 0.
|
Mesenchymal Precursor Cells (MPC) 25 M
n=35 participants at risk
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (5.0x10\^5 MPCs/min) on Day 0.
|
|---|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
17.1%
6/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Bradycardia
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Arteriospasm coronary
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Pyrexia
|
14.7%
5/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Chest pain
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.4%
4/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Fatigue
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Catheter site haematoma
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.3%
5/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.7%
5/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.7%
5/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Influenza
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
23.5%
8/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.3%
5/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
23.5%
8/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.3%
5/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Lethargy
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Dizziness postural
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Nervous system disorders
Presyncope
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.4%
4/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Vascular disorders
Peripheral coldness
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiac failure
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.6%
3/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Angina pectoris
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
8.8%
3/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
11.8%
4/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
14.7%
5/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.7%
2/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Rales
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
2.9%
1/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
|
Renal and urinary disorders
Dysphonia
|
5.9%
2/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/34 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
0.00%
0/35 • Up to approximately 8 years
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
|
Additional Information
Kenneth Borow, MD (Lead, Global Cardiovascular Development)
Mesoblast, Inc.
Phone: (212) 880-2060
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publications (abstracts, posters or presentations) must be presented to Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER