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NCT01212055 · ClinicalTrials.gov registry record
Apheresis of Patients With Immunodeficiency
A clinical trial of LAD-1 and DOCK8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 7
- Enrollment target
- 1
- Study location
NCT01212055: Recruiting study of LAD-1 and DOCK8, sponsored by National Cancer Institute (NCI).
NCT01212055 is a study of LAD-1 and DOCK8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212055, a study of LAD-1 and DOCK8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Gene therapy is being investigated as a possible treatment for individuals with immunodeficiency diseases or other conditions that make it difficult to fight off infection. Gene therapy avoids problems with donor identification and possible rejection of bone marrow transplant by using the patient s own modified blood cells to help treat the disease. Researchers are interested in collecting stem cells from the blood of individuals with immunodeficiency diseases in order to use the cells to develop potential gene therapy treatments. Objectives: \- To collect blood stem cells from patients with immunodeficiency diseases tto test our ability to correct the defects of these cells in the test tube. Eligibility: * Individuals between 18 and 40 years of age with immunodeficiency diseases. * Individuals with human immunodeficiency virus (HIV) will not be able to participate in this study. Design: * Participants will provide an initial blood sample for disease screening (such as hepatitis B and C, syphilis, or viruses like the Epstein-Barr virus, herpes simplex virus, or toxoplasmosis) and to check kidney and liver function. * Starting 5 days before blood donation, participants will receive daily injections of a drug called G-CSF (granulocyte colony stimulating factor, or filgrastim), which pushes stem cells out of the bone marrow and into the bloodstream. Participants will receive the injections at the National Institutes of Health Clinical Center. * On day 5, participants will have a single leukapheresis procedure to collect the stem cells from the blood. * No additional treatment will be provided as part of this protocol. The cells that are collected will be used fore experiments in the lab and will not be used to treat individuals with these diseases.
Primary Outcome
Obtain granulocyte colony stimulating factor mobilized peripheral blood CD34+ hematopoietic stem cells (HSC) by apheresis for laboratory research studies for DOCK8 deficiency, LAD-1, and GATA2 deficiency.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-11-08 |
What NCT01212055 shows while recruiting
NCT01212055 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 3 conditions, with LAD-1 appearing as the primary indexed condition, and to 0 interventions.
NCT01212055 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01212055 about?
NCT01212055 is a clinical study titled "Apheresis of Patients With Immunodeficiency". Background: \- Gene therapy is being investigated as a possible treatment for individuals with immunodeficiency diseases or other conditions that make it difficult to fight off infection. Gene therapy avoids problems with donor identification and possible rejection of bone marrow transplant by usin...
What is the current status of trial NCT01212055?
This trial is currently recruiting. The enrollment target is 7 participants. The study started on 2010-11-08.
What conditions does trial NCT01212055 study?
This clinical trial studies the following conditions: LAD-1, DOCK8, GATA2 Deficancy.
Who is sponsoring clinical trial NCT01212055?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01212055 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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