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Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379442
Recruitment Status : Terminated
First Posted : March 5, 2015
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Graft-Versus-Host Disease
Intervention Biological: MSC
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMSC
Hide Arm/Group Description Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title BMSC
Hide Arm/Group Description Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Proportion of Subjects Without a Treatment Related Severe Adverse Event
Hide Description The number of subjects without a treatment related severe adverse event (TRSAE) within 56 days of treatment.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BMSC
Hide Arm/Group Description:
Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMSC
Hide Arm/Group Description Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids. Target dose of 2 times 10e^6 MSC/kg for up to 12 doses
All-Cause Mortality
BMSC
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
BMSC
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMSC
Affected / at Risk (%)
Total   0/1 (0.00%) 
One subject completed the protocol, and the FDA placed the study on hold due to NIH operational issues. Since the cellular product of bone-marrow derived mesenchymal stem cells is no longer available, the protocol was terminated on December 13, 2017.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sawa Ito, MD
Organization: NHLBI, NIH
Phone: 301-326-5233
EMail: itos3@upmc.edu
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT02379442     History of Changes
Other Study ID Numbers: 150088
15-H-0088
First Submitted: March 4, 2015
First Posted: March 5, 2015
Results First Submitted: April 8, 2019
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019