Brief Title
A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
Official Title
A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of Injections of Ex Vivo Expanded Cultured Occipital Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
Brief Summary
Evaluate the ability of Ji Gami(TM) DO 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
Condition
Androgenetic Alopecia
Intervention
Autologous cultured dermal cells
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
21
Start Date
June 2009
Primary Completion Date
September 2010
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.
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 minoxidil, or 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.
- 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 and/or study areas.
- Prior surgery in the treatment area.
- 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.
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
NCT01451099
Organization ID
CA-0002062
Responsible Party
Sponsor
Study Sponsor
Aderans Research Institute
Study Sponsor
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Verification Date
February 2012