Improved methods for selecting cells in bone marrow transplants

Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation

This study is testing new ways to select cells from healthy donors for bone marrow transplants to see if it can make the procedure safer and more effective for patients with blood disorders.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00001529 on ClinicalTrials.gov

What this trial studies

This study focuses on enhancing the safety and effectiveness of allogeneic bone marrow transplants by exploring new techniques for cell selection. Researchers aim to use peripheral blood stem cells (PBSC) collected from healthy donors, utilizing G-CSF to mobilize these cells. The study will analyze the collected samples to develop methods that can reduce the risk of graft-versus-host disease (GVHD) while preserving the donor's immune function. By testing various purification approaches, the research seeks to improve transplantation outcomes for patients with blood disorders.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged 18 to 60 who meet specific health criteria.

Not a fit: Patients with active infections, significant health issues, or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer bone marrow transplant procedures with reduced risk of complications for patients.

How similar studies have performed: Previous studies have shown promise in using T cell depletion and delayed lymphocyte add-back strategies, indicating potential success for this approach.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Andre Larochelle, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Richard A Gustafson, R.N.

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