Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01071577
First received: February 18, 2010
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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.

Condition
Bone Marrow
Bone Marrow Stromal Cells
Mesenchymal Stem Cells
Blood Donors

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Bone Marrow From Healthy Volunteers and Patients for the Production of Clinical Bone Marrow Stromal Cell (BMSC) Products

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: January 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071577

Contacts
Contact: Lee C England, P.A.-C (301) 594-2471 englandlc@mail.nih.gov
Contact: David F Stroncek, M.D. (301) 435-4801 dstroncek@mail.cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David F Stroncek, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01071577     History of Changes
Other Study ID Numbers: 100053, 10-CC-0053
Study First Received: February 18, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone Marrow Stromal Cells
Mesenchymal Stem Cells
Immune Modulation
Tissue Regeneration
Bone Marrow
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on August 19, 2014