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NCT01071577 · ClinicalTrials.gov registry record
Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- 65
- Enrollment target
NCT01071577 is a clinical trial that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 65 participants.
The verdict
NCT01071577 was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- 65 participants
- Enrollment target
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-03-17 |
| Est. Completion | 2018-08-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071577
The ClinicalTrials.gov registry entry for NCT01071577 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01071577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01071577 about?
NCT01071577 is a clinical study titled "Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products". 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 us...
What is the current status of trial NCT01071577?
This trial is currently terminated. The enrollment target is 65 participants. The study started on 2010-03-17. Estimated completion is 2018-08-07.
Who is sponsoring clinical trial NCT01071577?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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