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Bone marrow donors sought to grow cells for future therapies

NCT ID NCT01071577

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

65 people

The number who actually took part.

Started

Mar 2010

Finished

Aug 2018

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States