NCT01765803

Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells

A Single Institution Feasibility Study to Assess Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Mellaril	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-01-10
• Last updated: 2016-04-14
• Results posted: 2015-07-20

Locations

1 site across 1 country: United States