Peripheral Blood Stem Cells Obtained From Normal Volunteers for Studying Retroviral Vector Mediated Gene Transfer Into Primitive Hematopoietic Cells and Vector Mediated Transgene Expression in Mature Hematopoietic Lineages
Completed
Conditions studied: Immunodeficiency
In brief
These studies are designed to evaluate the relative efficiency of gene transfer into primitive human hematopoietic cells by comparing lentiviral and foamy virus vectors as vehicles for transfer and expression of globin genes. Normal volunteers will serve as research participants. Each will receive a 4 day course of Granulocyte-Colony Stimulating Factor (G-CSF) after which a peripheral blood apheresis will be performed to recover a mononuclear cell population enriched in primitive hematopoietic cells. The stem and progenitor cells will be purified by selection based on expression of the CD34 antigen. The CD34+ population will be cultured in vitro with various cytokines and transduced with vector particles. The efficiency of gene transfer will be evaluated in the transduced CD34+ population, in progenitors contained within that population by culture in semisolid media and in cells capable of establishing human hematopoiesis in immunodeficient mice. The level of transgene expression will be evaluated in mature hematopoietic lineages that develop in vitro or in immunodeficient mice.
Key facts
- Study ID
- NCT00758992
- Run by
- St. Jude Children's Research Hospital
- People needed
- 14
- Starts
- 2006-10-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2016-03-14
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age greater than or equal to 18 years and less than or equal to 40.
- Meets donation criteria for autologous blood donors per SJCRH Blood Donor Center standard operating procedure.
- Adequate venous access for apheresis on examination as per the judgment of the Blood Donor Center nursing staff, physician staff or physician investigators.
You may not qualify if…
- Females - lactating.
- Concurrent use of systemic medications that in the judgment of the physician investigators adversely affect platelet function, such as aspirin or non-steroidal antiinflammatory agents.
- Any of the following diagnoses (prior or current):
- pulmonary disease.
- inflammatory disorder.
- coronary artery disease.
- stroke (cerebral vascular accident).
- hypertension.
- cardiac arrhythmias.
- venous thrombosis.
- pulmonary embolus
- hematological disease.
- eczema or psoriasis.
- Additional eligibility criteria (to be obtained after signing informed consent)
- Body mass index less than 30 kg/m2.
- No hepatomegaly or splenomegaly.
- Hemoglobin greater than or equal to 12.5 g/dL.
- Platelet count greater than or equal to 150,000/mm3.
- Total WBC > 4200/ul and neutrophil count >1800/ul.
- Females - not pregnant (negative serum or urine; to be obtained after signing informed consent).
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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