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 November 14, 2024

Recruiting

Keywords

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

ClinConnect Summary

This clinical trial is studying a new way to improve bone marrow transplants, particularly for patients with serious blood disorders like leukemia. The researchers are focusing on reducing a serious complication called graft-versus-host disease (GVHD), which can happen when transplanted white blood cells attack the recipient's own cells. They aim to use peripheral blood, instead of bone marrow, to collect stem cells and remove the cells that can cause GVHD. By doing this, they hope to make the transplant safer while still providing the necessary stem cells that help produce healthy blood.

To participate in this trial, individuals must be healthy adults between the ages of 18 and 60, with no active infections or serious health issues. They should have normal liver and kidney function and should be able to understand and provide consent for the study. Eligible participants can expect to undergo a two-step process involving the collection of their blood after receiving a growth factor treatment, which helps increase stem cell production. The trial is currently recruiting participants, and it aims to gather important information about how this new method can improve outcomes for patients needing bone marrow transplants.

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.

Trial Officials

Andre Larochelle, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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