- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765803
Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells
March 15, 2016 updated by: New Mexico Cancer Care Alliance
A Single Institution Feasibility Study to Assess 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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Health Sciences Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, non-smoking subjects (male or female)
- Age: 18 to 55 years
- All subjects must agree to refrain from consuming alcohol during for 48 hours after taking thioridazine.
- Performance status Karnofsky score of 100%.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having not undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand the purpose and procedures of this study, and the willingness to sign a written informed consent document.
- Only subjects whose laboratory testing, including platelet counts and transaminase levels are within normal limits are eligible.
- Subjects must pass pre-treatment screening by EKG to rule out long QT syndrome or subclinical cardiac arrhythmia.
Exclusion Criteria:
- Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, a febrile illness within 35 days of study entry, or psychiatric illness or dementia, or social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Concomitant use of phenytoin excludes potential subjects from participation.
- Subjects with known long QT syndrome or known history of cardiac arrhythmias are excluded from participation.
- Subjects taking drugs known to inhibit P450 CYP2D6 are excluded from participation.
- Subjects who received an investigational agent within 28 days of dosing with thioridazine on this protocol are excluded from participation.
- Subjects who received thioridazine within 7 days of dosing on this protocol are excluded from participation.
- Subjects who have had pelvic radiation are excluded from participation.
- Subjects who have received myeloablative regimens at any time are excluded from participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Mellaril (thioridazine)
A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CD34+ Progenitor Cell Mobilization
Time Frame: 8 hours following treatment
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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
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8 hours following treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: Up to 1 month after treatment
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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. |
Up to 1 month after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart S Winter, MD, University of New Mexico Health Sciences Center/Pediatric Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
January 8, 2013
First Submitted That Met QC Criteria
January 9, 2013
First Posted (ESTIMATE)
January 10, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 14, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INST 1208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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