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Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications

NCT01633229 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-12-12

No results posted yet for this 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.

Conditions

  • Graft-Versus-Host Disease

Interventions

PROCEDURE

Bone Marrow Stromal Cell Infusion

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Minocher M Battiwalla, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-14
Primary Completion
2013-07-01
Completion
2018-03-08

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 NCT01633229 on ClinicalTrials.gov