A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

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.
• •Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
• •Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
• •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.
• •Clinically significant dermatologic condition in donation or study areas.
• •Prior surgery in the donor or study areas.
• •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.