Status:
COMPLETED
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
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Doris Duke Charitable Foundation
Conditions:
Immunodeficiency
Eligibility:
All Genders
18-40 years
Brief Summary
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 ex...
Detailed Description
The peripheral blood has been established as a source of hematopoietic stem cells, providing an alternative source to bone marrow for hematopoietic reconstitution of patients with oncologic, hematolog...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00758992
Start Date
October 1 2006
End Date
July 1 2015
Last Update
March 14 2016
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105