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Protocol Details

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.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0053

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Bone Marrow Stromal Cells;
Mesenchymal Stem Cells;
Immune Modulation;
Tissue Regeneration

Recruitment Keyword(s)

Bone Marrow;
Healthy Volunteer;
HV

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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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Eligibility

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

a. Hemoglobin level

African American women < 11.5 grams/dL

Other women < 12.0 grams/dL

Men < 12.5 grams/dL

b. HCT

African American women < 34%

Other women < 36%

Men < 38%

c. Platelets less than 150 x 10(3)/microL

d. Absolute neutrophil count less than 1.0 x 10(3)/microL

-Prolonged coagulation assays

a. PT greater than 15.2 seconds

b. 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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Citations:

Bianco P, Riminucci M, Gronthos S, Robey PG. Bone marrow stromal stem cells: nature, biology, and potential applications. Stem Cells. 2001;19(3):180-92.

Mankani MH, Kuznetsov SA, Shannon B, Nalla RK, Ritchie RO, Qin Y, Robey PG. Canine cranial reconstruction using autologous bone marrow stromal cells. Am J Pathol. 2006 Feb;168(2):542-50.

Mankani MH, Kuznetsov SA, Wolfe RM, Marshall GW, Robey PG. In vivo bone formation by human bone marrow stromal cells: reconstruction of the mouse calvarium and mandible. Stem Cells. 2006 Sep;24(9):2140-9. Epub 2006 Jun 8.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David F. Stroncek, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 435-4801
dstroncek@mail.cc.nih.gov

Lee C. England, P.A.-C
National Institutes of Health Clinical Center (CC)
BG 10 RM 3C720
10 CENTER DR
BETHESDA MD 20814
(301) 594-2471
englandlc@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01071577

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