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Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 389 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Notable

    Primary endpoint revised

    Eligibility criteria shortened, about 8 words; Publications: details revised at 1 of 3 entries

    Show what changed: Primary endpoints
    [...] hniques, gene transfer, analysis of cell surface antigens, & analysis of migra...
    Show what changed: 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, my [...] ral vascu [...]

  3. Minor

    26 amendments

    26 re-verifications since 2025-08-09, no change to tracked fields

    v362-v387

  4. Minor

    Study description revised

    Show what changed: Study description
    [...] F mobilized PBSCs collected by apheresis from healthy donors, since this is the cell source that will be used in all clin [...] necessary for hematopoietic reconstitution. At the same time, we will study whether G-CSF administration has an effect on [...] rring in allogeneic bone marrow transplantation. Furthermore, the CD34+ cells collected will be a valuable resource for e [...]

    Study Status, Study Descriptionv361

  5. Minor

    Eligibility criteria expanded, about 62 words

    Show what changed: Eligibility criteria
    INCLUSION CRITERIA: Healthy individual aged between 18 andto 60 years. No active infection or history of recurrent infection. Normal renal function: creatinine less than <1.5 mg/dL or estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73 m^2, with no significant proteinuria less than 1+. Normal liver function: bilirubin less than 1<2.50 mg/dL (when unconjugated), transaminasetransaminases less<2.0x thanULN 1.5-in foldthe upper limitabsence of normalknown liver disease. Normal blood count: WBC 32,000500-1011,000/microliter, ANC >1,500/microliter, platelets >150,000/microliter, hemoglobin [...] [...]

    Study Status, Eligibilityv360

  6. Minor

    20 amendments

    20 re-verifications since 2025-01-14, no change to tracked fields

    v340-v359

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00001529
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators: New York Genome Center
Conditions Graft-Versus-Host Disease, Graft-versus-leukemia, Donor Apheresis
Enrollment 500 participants
Start Date
Updated on ClinicalTrials.gov