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

Stopped early · Phase 1/Phase 2

Conditions studied: Graft-Versus-Host Disease

In brief

Background: \- Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow from healthy volunteers. Objectives: \- To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s immune system responds to BMSC. Eligibility: \- People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD. People who have had certain previous immunosuppressive therapy may be ineligible. Design: * Participants will be screened with medical history, physical exam, and blood tests. They will have a GVHD exam, including skin and stool tests. They must have a functioning central line. * Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the rest of the weeks. * Up to 12 cell infusions: * Participants will come to the clinic twice weekly. * They will get medicine to prevent side effects (like Tylenol and Benadryl). * BMSC will be given through a small plastic tube in an arm vein or through an IV catheter. It will last 20 60 minutes. * Participants will be monitored for 1 hour. * Follow-up visits: Up to twice a week, participants will have physical exam and blood tests. They may have a GVHD exam. * Participants who have a tissue biopsy outside the study will be asked to send a sample to the study.

Key facts

Study ID
NCT02379442
Run by
National Heart, Lung, and Blood Institute (NHLBI)
People needed
1
Starts
2015-02-23
Expected to finish
2017-12-13
Last updated by the study team
2019-05-01

Who can join

Age: 4 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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