Trial Outcomes & Findings for Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids (NCT NCT02379442)
NCT ID: NCT02379442
Last Updated: 2019-05-01
Results Overview
The number of subjects without a treatment related severe adverse event (TRSAE) within 56 days of treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
56 days
Results posted on
2019-05-01
Participant Flow
Participant milestones
| Measure |
BMSC
Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e\^6 MSC/kg for up to 12 doses
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids
Baseline characteristics by cohort
| Measure |
BMSC
n=1 Participants
Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e\^6 MSC/kg for up to 12 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 daysThe number of subjects without a treatment related severe adverse event (TRSAE) within 56 days of treatment.
Outcome measures
| Measure |
BMSC
n=1 Participants
Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e\^6 MSC/kg for up to 12 doses
|
|---|---|
|
Proportion of Subjects Without a Treatment Related Severe Adverse Event
|
1 Participants
|
Adverse Events
BMSC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place