A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)



Status:Recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2012

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A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of ex Vivo-cultured, Expanded, Occipital Autologous Dermal and Epidermal Cells, Injected Into the Hair Loss Area of the Scalp of Male and Female Subjects With Alopecia


Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and
female subjects with hair loss.


Inclusion Criteria:

- Male and female volunteers 18-50 years old, inclusive.

- Women of childbearing potential must use an adequate form of contraception during
study participation.

- Hair loss consistent with Grade III-Vertex, IV, or V based on the based on the
Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of
the vertex circle, or class 1 or class 2 based on the Ludwig scale.

- 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; also agrees to abstain from shaving the
head during the course of the study.

Exclusion Criteria:

- Women who are pregnant or lactating.

- 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 symptoms of any acute illness within 30 days prior to excision
day.

- Any condition that compromises the ability to understand or comply with study
requirements.

- 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 zones.

- Prior surgery in the donor or study zones.

- 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.
We found this trial at
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Denver, Colorado 80239
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Akron, Ohio 44311
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Dallas, Texas 75231
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Greer, South Carolina 29651
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Pinellas Park, Florida 33781
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Santa Rosa, California 95405
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Tucson, Arizona 85710
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