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

Completed · Phase 2

Conditions studied: Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness

In brief

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.

Key facts

Study ID

NCT01451125

Run by

Aderans Research Institute

People needed

43

Starts

2010-05-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Radiant Research, Inc. — Birmingham, Alabama, United States
• Radiant Research, Inc. — Tucson, Arizona, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• Radiant Research, Inc. — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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