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Clinical trialNCT01633229CompletedPhase 1Interventional

Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications

SponsorNational Heart, Lung, and Blood Institute (NHLBI)Enrollment10Graft-Versus-Host Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Minocher M Battiwalla, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Nov 2011
Primary completion
1 Jul 2013
Completion
8 Mar 2018
Last update posted
12 Dec 2019
Registered enrollment
10
Registry id
NCT01633229

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.