| Conditions: |
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Bone Marrow - Bone Marrow Stromal Cells - Mesenchymal Stem Cells - Blood Donors |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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- 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(Degree) 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
- Adequate clinical parameters (all of the following):
- Afebrile (temperature less than 38(Degree) C)
- Systolic blood pressure greater than 100 & less than 180 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) 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(Degree) 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:
- Thrombocytopenia or other blood dyscrasias
- Bleeding diathesis
- Antibiotic use within the prior 48 hours
- Currently pregnant
- Febrile (temperature greater than 38(Degree) 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 less than 11.5 grams/dL
2. Platelets less than 100 x 10(3)/microL
3. 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 anti-HIV1/2, anti-HCV, or HBsAg
- Active tuberculosis infection
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| NCT ID: |
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NCT01071577 |
| Primary Contact: |
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Principal Investigator
David F Stroncek, M.D.
National Institutes of Health Clinical Center (CC)
Lee C England, P.A.-C
Phone: (301) 594-2471
Email: englandlc@mail.nih.gov
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| Backup Contact: |
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Email: dstroncek@dtm.cc.nih.gov
David F Stroncek, M.D.
Phone: (301) 496-9702
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |