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Trial record 28 of 29 for:    stem cell Spinal Cord Injury AND bone

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

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ClinicalTrials.gov Identifier: NCT01765803
Recruitment Status : Terminated (Primary objective not met after planned interim analysis)
First Posted : January 10, 2013
Results First Posted : July 20, 2015
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Oxnard Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Healthy Subjects
Intervention Drug: Mellaril
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mellaril (Thioridazine)
Hide Arm/Group Description

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

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.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Mellaril (Thioridazine)
Hide Arm/Group Description

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

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.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
34
(24 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
1.Primary Outcome
Title CD34+ Progenitor Cell Mobilization
Hide Description 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
Time Frame 8 hours following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mellaril (Thioridazine)
Hide Arm/Group Description:

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

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.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of total WBC count
CD34+ cells at baseline 0.05  (0.015)
CD34+ cells at 8 hours 0.05  (0.018)
Difference between baseline and 8 hours 0  (0.011)
2.Secondary Outcome
Title Toxicity
Hide Description

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.

Time Frame Up to 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mellaril (Thioridazine)
Hide Arm/Group Description:

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

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.

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Grade 1 somnolence 4
Returned to baseline within 24 hours 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mellaril (Thioridazine)
Hide Arm/Group Description

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

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.

All-Cause Mortality
Mellaril (Thioridazine)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mellaril (Thioridazine)
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mellaril (Thioridazine)
Affected / at Risk (%) # Events
Total   4/6 (66.67%)    
Nervous system disorders   
Somnolence (Sleepiness) * 1  4/6 (66.67%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stuart Winter, MD
Organization: University of New Mexico
Phone: 505-272-4461
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01765803     History of Changes
Other Study ID Numbers: INST 1208
First Submitted: January 8, 2013
First Posted: January 10, 2013
Results First Submitted: June 19, 2015
Results First Posted: July 20, 2015
Last Update Posted: April 14, 2016