Recruiting

Cell Selection

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT00001529

Conditions

Graft-Versus-Host Disease

Graft-versus-leukemia

Donor Apheresis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

G-CSF

Study Details

Brief summary:

Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old.

One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death.

In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD.

The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells.

In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells.

The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.

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Conditions

Graft-Versus-Host Disease

Graft-versus-leukemia

Donor Apheresis

Study ID

NCT00001529

Start date

Mar 18, 1996

Status verified date

Jun 23, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • Healthy individual aged 18 to 60 years.
  • No active infection or history of recurrent infection.
  • Normal renal function: creatinine <1.5 mg/dL or estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73 m\^2, with no significant proteinuria.

Normal liver function: bilirubin <2.0 mg/dL (when unconjugated), transaminases <2.0x ULN in the absence of known liver disease.

Normal blood count: WBC 2,500-11,000/microliter, ANC >1,500/microliter, platelets >150,000/microliter, hemoglobin >12.0 g/dL.

  • Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke.
  • Healthy female subjects of childbearing age should have a negative serum pregnancy test with one week of beginning G-CSF administration.
  • Female subjects should not be lactating.
  • Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test.
  • Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol.
  • Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry.

EXCLUSION CRITERIA:

  • Active viral, bacterial, fungal or parasite infection.
  • Female with positive pregnancy test or lactating.
  • Active or moderate-to-severe autoimmune disease that is currently treated or expected to require immunosuppressive therapy. Candidates with stable, well-controlled mild autoimmune disease may be considered on a case-by-case basis.
  • Active or recent malignancy within the past 5 years. Individuals with remote (>5 years) histories of low-risk malignancies in remission (e.g., localized prostate cancer) or treated basal cell carcinoma may be included.
  • History of any hematologic disorders.
  • History of clinically significant cardiovascular disease (e.g., symptomatic coronary artery disease, uncontrolled hypertension). Minor risk factors must be evaluated on a case-by-case basis (e.g., controlled hypertension).
  • Any positive serum screening test as listed in eligibility.
  • Allergy to G-CSF or bacterial E coli products.
  • Administration of NSAID within. 5-7 days of starting the protocol, depending on drug half-life.
  • History of G-CSF administration and leukapheresis within past 3 months.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Healthy volunteers

Interventions

G-CSF

After medical clearance, volunteers will undergo outpatient mobilization with daily subcutaneous injections of filgrastim (G-CSF). The first dose will be administered at the NIH Clinical Center, with one-hour monitoring for immediate reactions. Volunteers may either return to NIH for daily injections or self-administer at home after training.

Primary outcome measure

  • Provide a source of primitive hematopoietic cells from mobilized blood for laboratory studies including optimization of culture and expansion, preservation techniques, gene transfer, analysis of cell surface antigens, &amp; analysis of migra... [ Time Frame: End of Study ]

Central Contacts and Locations

Central contacts

Richard A Gustafson, R.N.

(301) 402-5822richard.gustafson@nih.gov

Andre Larochelle, M.D.

(301) 451-7139larochea@nhlbi.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Oct 2, 2026

Last verified

Jun 23, 2026

Keywords

  • G-CSF
  • Donor Apheresis
  • Graft Versus Host Disease
  • graft versus leukemia
  • Natural History
  • Normal Volunteer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.