Brief Title
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)
Official Title
A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of Ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells vs. Dermal Cells Into the Hair Loss Area of the Scalp of Subjects and Synergy With Application of Topical Minoxidil
Brief Summary
The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji
Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects
with hair loss.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change from baseline in hair number
Secondary Outcome
Effect of minoxidil
Condition
Androgenetic Alopecia
Intervention
Autologous cultured dermal and epidermal cells
Study Arms / Comparison Groups
Treated
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
43
Start Date
May 2010
Primary Completion Date
March 2012
Eligibility Criteria
Inclusion Criteria:
- Male and female volunteers 18 to 65 years old, inclusive
- Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on
Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the
vertex circle.
- Have no clinically significant disease or abnormal laboratory results taken at the
screening visit.
- Agree to abstain from use of any hair growth affecting oral or topical medication
including over the counter and herbal medications, finasteride or dutasteride during
the course of this study (other than minoxidil as required in this study).
Exclusion Criteria:
- Known sensitivity to DMEM/F-12 or any component of the study material.
- Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin
sulfate.
- Subjects who have used any oral or topical medication including over the counter and
herbal medications for the treatment of hair loss within 6 months of study screening,
or finasteride or dutasteride within 12 months of study screening (with the exception
of minoxidil).
- A history of drug or alcohol abuse within 1 year of study enrollment.
- Clinically significant medical or psychiatric illness currently or within 30 days of
study screening as determined by the investigator.
- Any clinically significant abnormal laboratory parameters.
- A positive result at screening for human immunodeficiency virus (HIV 1 or 2),
Hepatitis B or C, HTLV I/II.
- Dermatologic condition in donation or treatment area.
- Prior surgery in the treatment and/or study areas.
- Insufficient hair or scarring in the donor area that might impact cell growth.
- Any disease or condition (medical or surgical) that, in the opinion of the
investigator, might compromise hematologic, cardiovascular, pulmonary, renal,
gastrointestinal, hepatic, or central nervous system function; or any condition that
would place the subject at increased risk.
- Hypersensitivity to minoxidil or the ingredients in the topical solution or foam
formulations.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01451125
Organization ID
CA-0004512
Responsible Party
Sponsor
Study Sponsor
Aderans Research Institute
Study Sponsor
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Verification Date
July 2013