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NCT00001405 · ClinicalTrials.gov registry record
Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes
A clinical trial of Granulomatous Disease, Chronic and Granuloma, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 850
- Enrollment target
- 1
- Study location
NCT00001405: Recruiting study of Granulomatous Disease, Chronic and Granuloma, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001405 is a study of Granulomatous Disease, Chronic and Granuloma that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 850 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001405, a study of Granulomatous Disease, Chronic and Granuloma, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 850 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
1\. To efficiently and safely mobilize to the peripheral blood and apheresis collect CD34+ PBSC patients with any inherited primary immune deficiency (PID) or other blood disorders where PBSC from these patients may be designated entirely or in part for future clinical treatment of the patient
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 1994-02-27 |
What NCT00001405 shows while recruiting
NCT00001405 is an observational study that tracks outcomes without assigning an intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap.
The record links to 5 conditions, with Granulomatous Disease, Chronic appearing as the primary indexed condition, and to 0 interventions.
NCT00001405 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001405 about?
NCT00001405 is a clinical study titled "Recruitment and Apheresis Collection of Peripheral Blood Hematopoietic Stem Cells, Mononuclear Cells and Granulocytes". 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 t...
What is the current status of trial NCT00001405?
This trial is currently recruiting. The enrollment target is 850 participants. The study started on 1994-02-27.
What conditions does trial NCT00001405 study?
This clinical trial studies the following conditions: Granulomatous Disease, Chronic, Granuloma, Leukocyte Disease, Genetic Disease, X-Linked, Genetic Disease, Inborn.
Who is sponsoring clinical trial NCT00001405?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001405 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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