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Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products

NCT01071577 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-10-02

No results posted yet for this study

Summary

Background:

* Bone marrow stromal cells (BMSCs) can be grown from bone marrow provided by healthy volunteers. Volunteer bone marrow donors for BMSCs are generally required to meet the same healthy history and infectious disease marker screening criteria as volunteer blood donors. BMSCs are being used to treat a number of immune system and cardiovascular disorders, including graft-versus-host disease (GVHD), heart disease, and vascular disease. The National Institutes of Health Clinical Center is interested in collecting bone marrow aspirates and biopsies from healthy volunteers to produce clinical-grade BMSCs to treat Clinical Center patients.
* This study will also collect bone marrow from autologous donors (donors who will later receive their own BMSCs) for further treatment.

Objectives:

\- To collect bone marrow aspirates and biopsies from healthy subjects and autologous donors in order to produce BMSCs.

Eligibility:

\- Individuals at least 18 years of age who are either healthy volunteers or individuals who will need to receive their own BMSCs.

Design:

* Prospective healthy volunteers will be asked a series of questions designed to identify exposure to human immunodeficiency virus (HIV), hepatitis B or C, or other transfusion-transmitted diseases. A blood sample will be collected and tested for the abovementioned diseases and for other problems that may prevent bone marrow donation.
* Prospective autologous donors will also have blood tests to evaluate their own suitability for bone marrow donation.
* Eligible participants will be scheduled to provide a marrow aspirate/biopsy, taken from the upper part of the thigh bone, using standard bone marrow donation techniques.
* The collected bone marrow will be processed into BMSCs at the National Institutes of Health.

Conditions

  • Bone Marrow Stromal Cells

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • David F Stroncek, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-17
Primary Completion
2016-12-31
Completion
2018-08-07

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 NCT01071577 on ClinicalTrials.gov