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NCT02359929 · ClinicalTrials.gov registry record · Phase 1
BMT Autologous MSCs for GvHD
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02359929 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 11 participants.
The verdict
NCT02359929, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Subjects in this study have had an allogeneic (blood or marrow cells from another person) blood or marrow transplant to treat leukemia, lymphoma or other cancer of the blood, and have now developed Graft Versus Host Disease (GVHD) that is not responding to standard treatment. GVHD is when the graft (transplanted bone marrow or blood) attacks the recipient's body. GVHD occurs early after transplant (acute) and/or sometimes months after transplant (chronic). Both forms can be life threatening; chronic GVHD can be a lifelong disabling condition. Mesenchymal stromal cells (MSCs) exist in tissues throughout the body. One place they are found is in the bone marrow and from here they can be obtained by needle aspiration, the same way bone marrow samples are obtained to test for leukemia. This study uses autologous MSCs obtained from the recipient with acute and/or chronic GVHD, which have a lower chance of being rejected. These MSCs may promote tolerance, helping the donor immune cells accept the recipient's body. This trial is being conducted as a step toward testing the long-term hypothesis that freshly cultured autologous MSC grown in platelet lysate-containing medium will modulate donor T-cell immune responses and reduce GVHD in allo-HSCT recipients. As a phase I dose escalation trial of autologous MSC in patients with acute and chronic GVHD, the main aim is to evaluate the safety of this therapy and its effects on GVHD biomarkers and T-cell phenotype
Interventions
- BIOLOGICAL Autologous mesenchymal stromal cells (MSCs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-01 |
| Est. Completion | 2021-01-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02359929
The ClinicalTrials.gov registry entry for NCT02359929 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Autologous mesenchymal stromal cells (MSCs) is the first listed.
NCT02359929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02359929 about?
NCT02359929 is a clinical study titled "BMT Autologous MSCs for GvHD". Subjects in this study have had an allogeneic (blood or marrow cells from another person) blood or marrow transplant to treat leukemia, lymphoma or other cancer of the blood, and have now developed Graft Versus Host Disease (GVHD) that is not responding to standard treatment. GVHD is when the graft ...
What is the current status of trial NCT02359929?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-01. Estimated completion is 2021-01-11.
What interventions are being tested in trial NCT02359929?
The interventions under investigation include: Autologous mesenchymal stromal cells (MSCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02359929?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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