A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)
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A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of a 1 Time Injection vs. Repeat Injections of ex Vivo Expanded Cultured Autologous Occipital Dermal and Epidermal Cells (Same Day as Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss
Study Start Date :
Actual Primary Completion Date :
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Biological: Autologous cultured dermal and epidermal cells
Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes 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.