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A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451151
First received: October 11, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Androgenetic Alopecia
Male Pattern Baldness
Female Pattern Baldness
Biological: Autologous cultured dermal and epidermal cells
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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 Into the Hair Loss Area of the Scalp of Subjects

Resource links provided by NLM:


Further study details as provided by Aderans Research Institute:

Primary Outcome Measures:
  • Change from baseline in hair number [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ]
  • Change from baseline in hair width [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ]
  • Time course of any treatment benefit [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: December 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • Paricipation 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451151

Locations
United States, California
Axis Clinical Trials, Inc.
Los Angeles, California, United States, 90036
United States, New York
Axis Clinical Trials, Inc.
New Hyde Park, New York, United States, 11042
Sponsors and Collaborators
Aderans Research Institute
  More Information

No publications provided

Responsible Party: Aderans Research Institute
ClinicalTrials.gov Identifier: NCT01451151     History of Changes
Other Study ID Numbers: CA-0004542
Study First Received: October 11, 2011
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Aderans Research Institute:
Androgenetic Alopecia
Male Pattern Baldness
Female Pattern Baldness
Hair Loss
Baldness

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014