Status:
RECRUITING
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
New York University and New York Genome Center
Conditions:
Graft-Versus-Host Disease
Graft-versus-leukemia
Eligibility:
All Genders
18-60 years
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, ...
Detailed Description
The NHLBI Stem Cell Transplantation program is exploring ways to make allogeneic transplantation safer and more widely applicable. Prior NHLBI transplant protocols have evaluated the strategy of using...
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.
Key Trial Info
Start Date :
March 18 1996
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00001529
Start Date
March 18 1996
Last Update
March 31 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892