| Participants |
Inclusion criteria
43 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. Able to provide informed consent after risks and benefits of the study have been explained. Be willing to undergo all study procedures. Ability to communicate effectively with study personnel. Have no clinically significant disease or abnormal laboratory evaluations 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, minoxidil, finasteride or dutasteride during the course of 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. Participants 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 enrolment. 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 HIV 1 or 2, Hepatitis B or C, HTLV I/II. Dermatologic condition in donation or study areas, or both. 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 hematological, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or CNS function; or any condition that would place the participant at increased risk.
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