Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with
Biological: Autologous cultured dermal cells
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01451099
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01451099
United States (6)
Atlanta, Georgia, United States, 30326
Atlanta, Georgia, United States
Chevy Chase, Maryland, United States, 20815
Chase, Maryland, United States
Boston, Massachusetts, United States, 02116
Boston, Massachusetts, United States
New York City, New York, United States, 10016
New York City, New York, United States
Raleigh, North Carolina, United States, 27609
Raleigh, North Carolina, United States
Houston, Texas, United States, 77056
Houston, Texas, United States
View full eligibility
Tris trial is registered with FDA with number: NCT01451099. The sponsor of the trial is Aderans Research Institute and it is looking for 21 volunteers for the current phase.
Official trial 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
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