Bone Marrow Stromal CellsNCT01071577
Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products
An observational study of Bone Marrow Stromal Cells, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Stromal Cells
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2010to 7 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers wanting to donate BMSC, may be NIH employees as well as Clinical Center patients.
Who may be able to join
- 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
Show all 38Show fewer
- 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
- Hemoglobin level
- African American women < 11.5 grams/dL
- Other women < 12.0 grams/dL
- Men < 12.5 grams/dL
- HCT
- African American women < 34%
- Other women < 36%
- Men < 38%
- Platelets less than 150 x 10(3)/microL
- Absolute neutrophil count less than 1.0 x 10(3)/microL
- Prolonged coagulation assays
- PT greater than 15.2 seconds
- 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
Who cannot join
- -Medical history that includes any of the following:
- Currently Pregnant
- Positive tests for anti-HIV1/2, anti-HCV, or HBsAg
- Active tuberculosis infection
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cells (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 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.
Read more
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.
Read the detailed description
Bone marrow stromal cells (BMSCs) can be grown from bone marrow aspirates and biopsies, and are being used to treat a number of disorders including: graft-versus-host disease (GVHD), ischemic heart disease, peripheral vascular disease and autoimmune diseases. The purpose of this protocol is to collect bone marrow aspirates and biopsies from healthy volunteers to produce clinical grade BMSCs to treat Clinical Center patients and to develop new methods for producing and assessing the quality of BMSCs. In some cases, the donors will be the recipients of the ex vivo expanded cells (autologous transplantation). In other cases, no matching of HLA or other antigens is required between the marrow donor and the BMSC recipient, so the donors will be required to meet the same healthy history and infectious disease marker screening criteria as volunteer blood donors. The BMSCs will be produced in the GMP Clinical Cell Processing Laboratory, located in the Cell Processing Section (CPS), Department of Transfusion Medicine (DTM), Clinical Center. After the BMSCs are produced by the Cell Processing Laboratory, they will be infused directly into Clinical Center patients on protocol, or cryopreserved and stored, and used as they are needed to treat Clinical Center patients. Up to 250 subjects will be enrolled in this study. This protocol will provide a mechanism for banking fresh and frozen BMSC products that can be used for patient care and research. This is not a treatment protocol. Subjects receiving these BMSC products will be enrolled in specific BMSC treatment protocols.
- Conditions
- Bone Marrow Stromal Cells
- Keywords
- Bone Marrow Stromal Cells, Mesenchymal Stem Cells, Immune Modulation, Tissue Regeneration, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers wanting to donate BMSC for allogeneic use | |
| Patients | Patients donating BMSC for autologous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Collection
Tissue Collection
Measured: At study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study start17 Mar 2010
- Primary completion31 Dec 2016
- Study completion7 Aug 2018
Why it stopped: The corresponding clinical trials have been completed or terminated; therefore, this study is no longer required to produce additional cells.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow Stromal CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David F Stroncek, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071577
- Sponsor's protocol ID
- 100053
- Other IDs
- 10-CC-0053
- Status last verified
- Oct 2025
- First submitted
- 18 Feb 2010
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin P, Zhao Y, Liu H, Chen J, Ren J, Jin J, Bedognetti D, Liu S, Wang E, Marincola F, Stroncek D. Interferon-gamma and Tumor Necrosis Factor-alpha Polarize Bone Marrow Stromal Cells Uniformly to a Th1 Phenotype. Sci Rep. 2016 May 23;6:26345. doi: 10.1038/srep26345.
PubMed 27211104
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cells (BMSC)Products
- ClinicalTrials.gov ID
- NCT01071577
- Acronym / sponsor ID
- 100053
- Conditions
- Bone Marrow Stromal Cells
- Keywords
- Bone Marrow Stromal Cells, Mesenchymal Stem Cells, Immune Modulation, Tissue Regeneration, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The corresponding clinical trials have been completed or terminated; therefore, this study is no longer required to produce additional cells.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 17 Mar 2010 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bone marrow stromal cells (BMSCs) can be grown from bone marrow aspirates and biopsies, and are being used to treat a number of disorders including: graft-versus-host disease (GVHD), ischemic heart disease, peripheral vascular disease and autoimmune diseases. The purpose of this protocol is to collect bone marrow aspirates and biopsies from healthy volunteers to produce clinical grade BMSCs to treat Clinical Center patients and to develop new methods for producing and assessing the quality of BMSCs. In some cases, the donors will be the recipients of the ex vivo expanded cells (autologous transplantation). In other cases, no matching of HLA or other antigens is required between the marrow donor and the BMSC recipient, so the donors will be required to meet the same healthy history and infectious disease marker screening criteria as volunteer blood donors. The BMSCs will be produced in the GMP Clinical Cell Processing Laboratory, located in the Cell Processing Section (CPS), Department of Transfusion Medicine (DTM), Clinical Center. After the BMSCs are produced by the Cell Processing Laboratory, they will be infused directly into Clinical Center patients on protocol, or cryopreserved and stored, and used as they are needed to treat Clinical Center patients. Up to 250 subjects will be enrolled in this study. This protocol will provide a mechanism for banking fresh and frozen BMSC products that can be used for patient care and research. This is not a treatment protocol. Subjects receiving these BMSC products will be enrolled in specific BMSC treatment protocols.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers wanting to donate BMSC for allogeneic use |
| Patients | – | –Patients donating BMSC for autologous use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers wanting to donate BMSC, may be NIH employees as well as Clinical Center patients.
Key inclusion criteria (38 listed)
- 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:
- EXCLUSION CRITERIA RELATED OR THIRD PARTY DONORS (ALLOGENEIC CELLS)
- Medical history that includes any of the following:
Key exclusion criteria (4 listed)
- Currently Pregnant
- Positive tests for anti-HIV1/2, anti-HCV, or HBsAg
- Active tuberculosis infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue Collection
Time frame: At study visit
Tissue Collection
Results and safety
The study was stopped early (reason given: The corresponding clinical trials have been completed or terminated; therefore, this study is no longer required to produce additional cells.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 27211104Jin P, Zhao Y, Liu H, Chen J, Ren J, Jin J, Bedognetti D, Liu S, Wang E, Marincola F, Stroncek D. Interferon-gamma and Tumor Necrosis Factor-alpha Polarize Bone Marrow Stromal Cells Uniformly to a Th1 Phenotype. Sci Rep. 2016 May 23;6:26345. doi: 10.1038/srep26345.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David F Stroncek, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Stromal Cells, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The corresponding clinical trials have been completed or terminated; therefore, this study is no longer required to produce additional cells.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Collection (time frame: At study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.