A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)

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Brief Title

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)

Official Title

A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of a 1 Time Injection vs. Repeat Injections of ex Vivo Expanded Cultured Autologous Occipital Dermal and Epidermal Cells (Same Day as Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change from baseline in hair number


Condition

Androgenetic Alopecia

Intervention

Autologous cultured dermal and epidermal cells


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

33

Start Date

January 2009


Primary Completion Date

August 2010

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.

          -  Have no clinically significant disease or abnormal laboratory results taken at the
             screening visit.

        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.

          -  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 and/or study areas.

          -  Prior surgery in the treatment area.

          -  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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01451073

Organization ID

CA-0002013


Responsible Party

Sponsor

Study Sponsor

Aderans Research Institute


Study Sponsor

, , 


Verification Date

February 2012