Trial Outcomes & Findings for hCT-MSCs for COVID19 ARDS (NCT NCT04399889)
NCT ID: NCT04399889
Last Updated: 2022-12-20
Results Overview
Number of infusion reactions measured by any one of the following: fever, anaphylaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
24 hours
Results posted on
2022-12-20
Participant Flow
Participant milestones
| Measure |
Open Label Infusion of hCT-MSC
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg (maximum 100 million cells).
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
1
|
1
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
Open Label Infusion of hCT-MSC
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg (maximum 100 million cells).
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
1
|
1
|
Baseline Characteristics
hCT-MSCs for COVID19 ARDS
Baseline characteristics by cohort
| Measure |
Open Label Infusion of hCT-MSC
n=10 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg (maximum 100 million cells).
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
72 years
STANDARD_DEVIATION 0 • n=7 Participants
|
62 years
STANDARD_DEVIATION 0 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumber of infusion reactions measured by any one of the following: fever, anaphylaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=10 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Infusion Reactions
|
0 infusion reactions
|
0 infusion reactions
|
0 infusion reactions
|
PRIMARY outcome
Timeframe: 28 daysNumber of later reactions attributed to the investigational product as measured by any one of the following: rash, infection, allergic reaction, or any other delayed symptoms associated with infusion of the investigational product.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=10 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Delayed Reactions
|
0 delayed reactions
|
0 delayed reactions
|
0 delayed reactions
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Data not collected on eight participants.
Number of participants who form new anti-HLA antibodies as measured by an antibody screen test at 28 days post first infusion of the investigational product.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=4 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Participants With Formation of New Anti-HLA Antibodies
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysPopulation: Participants who recovered.
Time to recovery, defined as discharge from the hospital (alive) or remaining in the hospital without the need for supplemental oxygen or other COVID-related medical care.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=5 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Time to Recovery
|
18 days
Interval 7.0 to 39.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 days after MSCsPopulation: Data not collected on eight participants.
Increase in PaO2/FiO2 ratio by 50% by Day 4 (96 hours after first infusion). PaO2/FiO2 may be calculated from an arterial blood gas or imputed from the SpO2/FiO2 table.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=4 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Participants With an Increase in PaO2/FiO2 Ratio
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Participants who were discharged to home.
The number of days from hospitalization to discharge to home.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=3 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Days to Hospital Discharge to Home
|
18 days
Interval 8.0 to 18.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=10 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Ventilator Free Days
|
25.5 days
Interval 0.0 to 80.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Data not collected on one participant.
Number of oxygen-free days defined as: 0 if the subject dies within 28 days of supplemental oxygen, 28-x if successfully liberated from supplemental oxygen x days after initiation, and 0 if the subject receives supplemental oxygen for \> 28 days.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
n=9 Participants
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Oxygen-free Days
|
0 days
Interval 0.0 to 21.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Open Label infusion of hCT-MSC participants were not randomized.
Outcome measures
| Measure |
Open Label Infusion of hCT-MSC
The first 10 consecutive patients all received 3 daily consecutive doses of hCT-MSC at a dose of 1 million cells/kg.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 Participants
Randomized to 3 daily consecutive doses of hCT-MSC at a dose of 100 million cells.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 Participants
Randomized to 3 daily consecutive infusions of placebo.
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Number of Screened Patients Who Are Enrolled and Randomized
|
—
|
1 Participants
|
1 Participants
|
Adverse Events
Open Label Infusion of hCT-MSC
Serious events: 6 serious events
Other events: 4 other events
Deaths: 5 deaths
Randomized Infusion of hCT-MSC
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Randomized Infusion of Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open Label Infusion of hCT-MSC
n=10 participants at risk
The first 10 consecutive patients will all receive investigational product.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 participants at risk
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo. The investigational product will be further randomized to the MSCs manufactured by Duke or University of Miami. These products are considered to be comparable.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 participants at risk
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
General disorders
Death NOS
|
20.0%
2/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/10 • 90 days
|
100.0%
1/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • 90 days
|
100.0%
1/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
Other adverse events
| Measure |
Open Label Infusion of hCT-MSC
n=10 participants at risk
The first 10 consecutive patients will all receive investigational product.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of hCT-MSC
n=1 participants at risk
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo. The investigational product will be further randomized to the MSCs manufactured by Duke or University of Miami. These products are considered to be comparable.
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
|
Randomized Infusion of Placebo
n=1 participants at risk
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo
Placebo: Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
General disorders
Edema limbs
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
General disorders
Fever
|
20.0%
2/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Cardiac disorders
Heart failure
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/10 • 90 days
|
0.00%
0/1 • 90 days
|
100.0%
1/1 • 90 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
2/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10 • 90 days
|
0.00%
0/1 • 90 days
|
0.00%
0/1 • 90 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place