Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications
Completed · Phase 1
Conditions studied: Graft-Versus-Host Disease
In brief
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.
Key facts
- Study ID
- NCT01633229
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 10
- Starts
- 2011-11-14
- Expected to finish
- 2018-03-08
- Last updated by the study team
- 2019-12-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 2.1 Breast feeding or pregnant females (due to unknown risk to fetus or newborn).
- 2.2 Allergic to gentamicin
- 2.3 Weight less than 20 kg (not informative for research sampling)
- 2.4 Patients with significant organ failure at baseline as evidenced by any of the following:
- <TAB>Symptomatic cardiac failure at rest or with minimal activity or exertion for which intervention is indicated
- <TAB>Creatinine > 3.0 X ULN
- <TAB>Decreased oxygen saturation at rest (e.g. pulse oximeter < 88% or PaO2 less than or equal to 55 mmHg)
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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