A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

Aderans

Status and phase

Completed

Phase 2

Conditions

Female Pattern Baldness

Male Pattern Baldness

Androgenetic Alopecia

Treatments

Biological: Autologous cultured dermal and epidermal cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT01451125

CA-0004512

Details and patient eligibility

About

The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects with hair loss.

Enrollment

43 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.
Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study (other than minoxidil as required in 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.
Subjects who have used 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 (with the exception of minoxidil).
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 or treatment area.
Prior surgery in the treatment and/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.
Hypersensitivity to minoxidil or the ingredients in the topical solution or foam formulations.