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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.

Official Title
-----------------
A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells vs Dermal Cells Into the Hair Loss Area of the Scalp of Subjects

Conditions
-----------------
Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness

Intervention / Treatment
-----------------
* Biological: Autologous cultured dermal and epidermal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br> | Biological: Autologous cultured dermal and epidermal cells<br>* A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness