Bone marrow donors sought to grow cells for future therapies
NCT ID NCT01071577
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study collected bone marrow from healthy volunteers and patients to produce bone marrow stromal cells (BMSCs), which are being studied for treating immune and heart diseases. Participants provided a bone marrow sample from the thigh bone. The goal was to create a supply of clinical-grade BMSCs for future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone marrow stromal cells (BMSCs)
- What this could lead to
- If successful, this could provide a source of BMSCs for treating immune and heart conditions like graft-versus-host disease.
- What could go wrong
- This is a tissue collection study, not a treatment trial. It was terminated early, so results may be limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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65 people
The number who actually took part.
- Started
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Mar 2010
- Finished
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Aug 2018
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy volunteers wanting to donate BMSC, may be NIH employees as well as Clinical Center patients.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA RELATED OR THIRD PARTY DONORS (ALLOGENEIC CELLS): * Age greater than or equal to 18 years old * Ability to give informed consent * Adequate clinical parameters (all of the following): * Afebrile (temperature less than 38 (Infinite) C) * Systolic blood pressure greater than 100 \& less than180 mmHg * Diastolic blood pressure greater than 50 \& less than 100 mmHg * Heart rate between 40-100 beats/minute * Females of child-bearing potential must have a negative pregnancy test and one of the following: * Be surgically sterile * Be abstinent until the marrow is collected * Use oral contraceptives, or other form of hormonal birth control * Use an intra-uterine device (IUD) as birth control * Use (by ensuring her male partner(s) use(s) barrier contraception (condom) as birth control INCLUSION CRITERIA AUTOLOGOUS DONORS * Age greater than or equal to 18 years old * Ability to give informed consent * Females of child-bearing potential must have a negative pregnancy test and one of the following: * Be surgically sterile * Be abstinent until the marrow is collected * Use oral contraceptives, or other form of hormonal birth control * Use an intra-uterine device (IUD) as birth control * Use (by ensuring her male partner(s) uses) barrier contraception (condom) as birth control EXCLUSION CRITERIA RELATED OR THIRD PARTY DONORS (ALLOGENEIC CELLS) * Medical history that includes any of the following: * Thrombocytopenia or other blood dyscrasias * Bleeding diathesis * Antibiotic use within the prior 48 hours * History of cancer * History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood Banking and Transfusion Services, American Association of Blood Banks. * Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel). * At risk for the possible transmission of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) by Blood and Blood Products * If female, pregnant within the past 6 weeks * Febrile (temperature greater than 38 (Infinite) C) * Systolic blood pressure less than 100 or greater than 180 mmHg * Diastolic blood pressure less than 50 or greater than 100 mmHg * Heart rate less than 40 or greater than 100 beats/minute * Anemia, thrombocytopenia, or leukopenia 1. Hemoglobin level African American women \< 11.5 grams/dL Other women \< 12.0 grams/dL Men \< 12.5 grams/dL 2. HCT African American women \< 34% Other women \< 36% Men \< 38% 3. Platelets less than 150 x 10(3)/microL 4. Absolute neutrophil count less than 1.0 x 10(3)/microL * Prolonged coagulation assays 1. PT greater than 15.2 seconds 2. PTT greater than 37.3 seconds * Positive tests for blood borne pathogens (as required by the Standards for Blood Banks and Transfusion Services, American Association of Blood Banks. The currently required tests include anti-HIV1/2, anti-HCV, Anti-HTVLI/II, anti-T. Cruzi, HBsAg, syphilis, and molecular testing for West Nile virus, HCV and HIV). * Experiencing fever, malaise, anorexia, weight loss or night sweats consistent with active tuberculosis infection EXCLUSION CRITERIA AUTOLOGOUS DONORS -Medical history that includes any of the following: * Currently Pregnant * Positive tests for anti-HIV1/2, anti-HCV, or HBsAg * Active tuberculosis infection
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States