Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells
This study will investigate the possibility of using the drug thioridazine (also called Mellaril) to increase the number of certain types of cells moving from the bone marrow to the circulation in a group of healthy humans. The types of cells we hope to collect are called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better understand a number of diseases and suggest new strategies for therapy. Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies, as a renewable source of replacement cells and tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Single Institution Feasibility Study to Assess Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells|
- CD34+ Progenitor Cell Mobilization [ Time Frame: 24 hours following treatment ] [ Designated as safety issue: No ]To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported
- Toxicity [ Time Frame: Up to 1 month after treatment ] [ Designated as safety issue: Yes ]
Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.
Any subject who receives treatment on this protocol will be evaluable for toxicity.
|Study Start Date:||June 2013|
|Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Mellaril (thioridazine)
A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Other Name: Thioridazine
This is a single-arm, feasibility study to test whether a single dose of Mellaril (thioridazine HCL) is able to effectively mobilize CD34+ cells in a set of health human subjects. This study does not involve the use of placebos, and subjects will serve as their own controls for CD34+ cell mobilization. We hypothesize that a single dose of Mellaril (thioridazine HCL) will mobilize CD34+ progenitor cells into human peripheral blood by a factor of at least 10 fold, from 4 to 40 cells/microliter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765803
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Stuart S Winter, MD||University of New Mexico Health Sciences Center/Pediatric Oncology|