Trial Outcomes & Findings for Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation (NCT NCT04397796)
NCT ID: NCT04397796
Last Updated: 2024-09-05
Results Overview
Incidence of AEs within 30 days of randomization.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
30 days
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
BM-Allo.MSC
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
BM-Allo.MSC
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
Baseline Characteristics
Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
Baseline characteristics by cohort
| Measure |
BM-Allo.MSC
n=3 Participants
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
n=1 Participants
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
64.0 years
n=7 Participants
|
62.8 years
STANDARD_DEVIATION 6.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Subjects with severe disease requiring ventilator support during COVID-19 infection
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Analysis population is all randomized subjects who received at least one dose of study intervention (safety analysis population)
Incidence of AEs within 30 days of randomization.
Outcome measures
| Measure |
BM-Allo.MSC
n=3 Participants
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
n=1 Participants
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
|---|---|---|
|
Number of Participants With Adverse Events Within 30 Days of Randomization
|
3 Participants
|
1 Participants
|
Adverse Events
BM-Allo.MSC
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BM-Allo.MSC
n=3 participants at risk
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
n=1 participants at risk
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
|---|---|---|
|
General disorders
Disease progression
|
100.0%
3/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
Other adverse events
| Measure |
BM-Allo.MSC
n=3 participants at risk
Subjects in the experimental arm will be administered BM-Allo.MSC
BM-Allo.MSC: BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
|
Placebo
n=1 participants at risk
Subjects in the control arm will be treated with placebo
Placebo: plasmalyte and human albumin
|
|---|---|---|
|
General disorders
Disease progression
|
100.0%
3/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
General disorders
Multiple organ dysfunction syndrome
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
General disorders
Necrosis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Infections and infestations
Septic shock
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Nervous system disorders
Metabolic encephalopathy
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Nervous system disorders
Cerebral haemorrhage
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Cardiac disorders
Cardiac arrest
|
66.7%
2/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Cardiac disorders
Cardiomegaly
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Cardiac disorders
Tachyarrhythmia
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Injury, poisoning and procedural complications
Ear injury
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From randomization through 30 days past the last dose, up to 34 days.
|
100.0%
1/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Vascular disorders
Lymphoedema
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Vascular disorders
Obstructive shock
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Skin and subcutaneous tissue disorders
Blister
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
|
Surgical and medical procedures
Endotracheal intubation
|
33.3%
1/3 • From randomization through 30 days past the last dose, up to 34 days.
|
0.00%
0/1 • From randomization through 30 days past the last dose, up to 34 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place