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 ] [ Designated as safety issue: No ]To determine the dose-related CD34+ progenitor cell mobilization by thioridazine when administered as a single agent in normal (healthy) study subjects
- Measure side effects [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]To describe the adverse events associated with thioridazine when administered as a single, 50 mg dose in healthy study subjects according to CTCAE version 4.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Mellaril (thioridazine)
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. Any subject who receives treatment on this protocol will be evaluable for toxicity. A second blood draw will occur at 24 hours post-treatment. All subjects will be followed for possible adverse events (toxicity) for 30 days after 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|