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

Phase 0
18 Years
55 Years
Open (Enrolling)
Stem Cell Mobilization

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

CD34+ Progenitor Cell Mobilization

Outcome Description:

To determine the dose-related CD34+ progenitor cell mobilization by thioridazine when administered as a single agent in normal (healthy) study subjects

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Stuart S Winter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Health Sciences Center/Pediatric Oncology


United States: Food and Drug Administration

Study ID:

INST 1208



Start Date:

June 2013

Completion Date:

September 2014

Related Keywords:

  • Stem Cell Mobilization
  • Mellaril
  • Thioridazine
  • CD34+
  • Stem cells
  • Progenitor cells
  • Peripheral blood
  • mobilization
  • peripheral blood
  • circulation



University of New Mexico Health Sciences Center Albuquerque, New Mexico  87131