Search / Trial NCT00001529

Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

Trial Information

Current as of March 05, 2024

Recruiting

Keywords

G Csf Donor Apheresis Graft Versus Host Disease Graft Versus Leukemia Natural History Normal Volunteer

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 T cell depleted marrow transplants followed by delayed lymphocyte add-back to control or prevent GVHD while conserving useful donor immune function against residual leukemia and infectious agents. Over the past ten years, a number of increasingly efficient methods have been used to deplete T cells but retain stem cells, and we have shown the safety and utility of the delayed T cell add-back ap...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • Healthy individual aged between 18 and 60 years.
  • No active infection or history of recurrent infection.
  • Normal renal function: creatinine less than 1.5 mg/dL, proteinuria less than 1+.
  • Normal liver function: bilirubin less than 1.5 mg/dL, transaminase less than 1.5- fold upper limit of normal
  • Normal blood count: WBC 3,000-10,000/microliter, ANC >1,500/microliter, platelets >150,000/microliter, hemoglobin >12.5g/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 within 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.
  • History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus.
  • History of cancer excluding squamous carcinoma of the skin.
  • History of any hematologic disorders.
  • History of cardiovascular disease or related symptoms such as chest pain, shortness of breath, history of cerebrovascular disease.
  • Any positive serum screening test as listed in eligibility.
  • Allergy to G-CSF or bacterial E coli products.
  • Administration of NSAID within 10 days of starting protocol.
  • History of G-CSF administration and leukapheresis within past 3 months.

Attachments

readout_NCT00001529_2024-03-05.pdf

4.5 MB

NCT00001529_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

End of Study

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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