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NCT01633229 · ClinicalTrials.gov registry record · Phase 1
Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01633229 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants.
The verdict
NCT01633229, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: * Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been used to treat other post-transplant complications, like marrow failure or tissue injury. * The National Institutes of Health (NIH) has developed a procedure for collecting and preserving BMSC from volunteer donors. These donors have passed tests to ensure that their cells are healthy enough to be used for treatment. Researchers want to use the collected cells to treat people with GVHD, marrow failure, or tissue injury following stem cell transplants. Objectives: \- To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem cell transplants. Eligibility: * Individuals between 18 and 75 years of age who have complications from stem cell transplants. * Complications are acute GVHD, poor bone marrow function, or tissue or organ damage. Design: * Participants will be screened with a physical exam and medical history. They will also have imaging studies and blood tests. * Participants will provide blood, skin, and bone marrow samples before the BMSC treatment. Additional samples, including tissue samples, will be collected after the start of treatment. * Participants will have up to three BMSC infusions. There will be a week between each infusion. Participants will be monitored closely during each infusion. Any side effects will be treated. * Treatment will be monitored with frequent blood tests and physical exams. * After the end of the infusions, participants will have regular followup visits for up to 2 years.
Interventions
- PROCEDURE Bone Marrow Stromal Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-11-14 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01633229
The ClinicalTrials.gov registry entry for NCT01633229 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 Bone Marrow Stromal Cell Infusion is the first listed.
NCT01633229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01633229 about?
NCT01633229 is a clinical study titled "Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications". Background: * Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been...
What is the current status of trial NCT01633229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-11-14. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT01633229?
The interventions under investigation include: Bone Marrow Stromal Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01633229?
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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