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Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 349 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Re-verified, no change to tracked fields

  3. Minor

    Eligibility criteria expanded, about 27 words

    Publications: details revised at 1 of 3 entries

    Show what changed: Eligibility criteria
    * ELIGIBILITY CRITERIA: Patients (Patients with a genetically [...] inical history consistent with PID or other blood disorder) 1. Patients will have a genetically defined PID or have a clini [...] of PID or other blood disorder, must be 18-70 years of age, 2. Some patients may have active bacterial or fungal infection at the time of study entry. 3. Preserved renal function (creatinine less than or equal to 2 [...] ed hematologic function (WBC greater than or equal to1000/mm\^3;granulocytes greater than or equal to 500/mm\^3; platelets greater than or equal to 100,000; hematocrit g [...] scretion, with the caveat that p [...]

  4. Minor

    47 amendments

    47 re-verifications since 2024-09-21, no change to tracked fields

    v300-v346

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The research goal of this study is to obtain CD34+ hematopoietic stem cells (HSC) from peripheral blood and/or bone marrow, and Mononuclear Cells (lymphocytes and monocytes), and granulocytes (grans) from peripheral blood that will be used in the laboratory and/or in the clinic to develop new cell therapies for patients with inherited or acquired disorders of immunity or blood cells. Development of novel cellular therapies requires access to HSC, Mononuclear Cells and/or granulocytes as the essential starting materials for the pre-clinical laboratory development of gene therapies and other engineered cell products. HSC or blood cells from healthy adult volunteers serve both as necessary experimental controls and also as surrogates for patient cells for clinical scale-up development. HSC or blood cells from patients serve both as the necessary experimental substrate for novel gene therapy and cellular engineering development for specific disorders and as pre-clinical scale up of cellular therapies. Collection of cells from adult patients collected in the NIH Department of Transfusion Medicine (DTM) under conditions conforming to accepted blood banking clinical practice may also be used directly in or cryopreserved for future use in other NIH protocols that have all required regulatory approvals allowing such use. In summary, the research goal of this protocol is the collection of HSC or blood cells that may be used for both laboratory research and/or for clinical treatment in other approved protocols....
Trial Details
NCT Number NCT00001405
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Granuloma, Granulomatous Disease, Chronic, Leukocyte Disease, Genetic Disease, X-Linked, Genetic Disease, Inborn
Enrollment 850 participants
Start Date
Updated on ClinicalTrials.gov