A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451138
First received: October 11, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji Gami(TM) NDO 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 vs Dermal 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: 40
Study Start Date: November 2010
Primary Completion Date: October 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. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. 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.
  • 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.
  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: NCT01451138

Locations
United States, Alabama
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
United States, Arizona
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
United States, Florida
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
United States, Missouri
Radiant Research, Inc.
St Louis, Missouri, United States, 63141
Sponsors and Collaborators
Aderans Research Institute
  More Information

No publications provided

Responsible Party: Aderans Research Institute
ClinicalTrials.gov Identifier: NCT01451138     History of Changes
Other Study ID Numbers: CA-0004541
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
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014