A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995)

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

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

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
• Intervention / Treatment: Biological: Autologous cultured dermal and epidermal cells

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials, Inc.
    • Santa Rosa, California, United States, 95405
      • Radiant Research, Inc.
  • Colorado
    • Denver, Colorado, United States, 80239
      • Radiant Research, Inc.
  • Florida
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc.
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • New York
    • New Hyde Park, New York, United States, 11042
      • Axis Clinical Trials
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Radiant Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treated	Biological: Autologous cultured dermal and epidermal cells; A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aderans Research Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (ESTIMATE): October 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Baldness; Androgenetic Alopecia; Hair Loss; Female Pattern Baldness; Male Pattern Baldness
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: CA-0005995