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

Phase 2

Completed

• Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

• Registration Number: NCT01451125
• Lead Sponsor: Aderans Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-13
• Primary Completion: 2012-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in hair number	51 weeks post-injection
Change from baseline in hair width	51 weeks post-injection
Time course of any treatment benefit	51 weeks post-injection

Secondary Outcome Measures

Name	Time	Method
Effect of minoxidil	Week 12, 18, 24, 33 and 51 post-injection

Trial Locations

Locations (1)

Radiant Research, Inc.; 🇺🇸 St Louis, Missouri, United States