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)

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Androgenetic alopecia
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Brief Title

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)

Official Title

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

Brief Summary

      Evaluate the ability of injections of Ji Gami(TM) CN 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 mixed population of dermal cells

Study Arms / Comparison Groups

 Treatment
Description:

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

34

Start Date

June 2012

Primary Completion Date

April 2013

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01669746

Organization ID

CA-0006931

Responsible Party

Sponsor

Study Sponsor

Aderans Research Institute

Study Sponsor

, ,

Verification Date

July 2013