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

NCT02379442 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-05-01

Study results available
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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.

Conditions

  • Graft-Versus-Host Disease

Interventions

BIOLOGICAL

MSC

MSC are an adherent, fibroblast-like cell population found in the bone marrow. Allogeneic MSC for treatment can be grown from bone marrow aspirates or biopsies of normal donors.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Sawa Ito, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-23
Primary Completion
2017-12-13
Completion
2017-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02379442 on ClinicalTrials.gov