Status:
COMPLETED
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss
Lead Sponsor:
Aderans Research Institute
Conditions:
Androgenetic Alopecia
Male Pattern Baldness
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01451021
Start Date
October 1 2008
Last Update
February 29 2012
Active Locations (3)
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1
Boston, Massachusetts, United States, 02116
2
New York, New York, United States, 10016
3
Houston, Texas, United States, 77056