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NCT02379442 · ClinicalTrials.gov registry record · Phase 1
Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02379442 is a Phase 1 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 1 participants.
The verdict
NCT02379442, a Phase 1 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-02-23 |
| Est. Completion | 2017-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02379442
The ClinicalTrials.gov registry entry for NCT02379442 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MSC is the first listed.
NCT02379442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02379442 about?
NCT02379442 is a clinical study titled "Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids". 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 t...
What is the current status of trial NCT02379442?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-02-23. Estimated completion is 2017-12-13.
What interventions are being tested in trial NCT02379442?
The interventions under investigation include: MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT02379442?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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