Text Size

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451125
First received: October 11, 2011
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji Gami(TM) DO in combination with minoxidil 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 and Synergy With Application of Topical Minoxidil

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Effect of minoxidil [ Time Frame: Week 12, 18, 24, 33 and 51 post-injection ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: May 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  • Have no clinically significant disease or abnormal laboratory results 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, finasteride or dutasteride during the course of this study (other than minoxidil as required in 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 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 (with the exception of minoxidil).
  • 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 or treatment area.
  • Prior surgery in the treatment and/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.
  • Hypersensitivity to minoxidil or the ingredients in the topical solution or foam formulations.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451125

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: NCT01451125     History of Changes
Other Study ID Numbers: CA-0004512
Study First Received: October 11, 2011
Last Updated: February 28, 2012
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 May 19, 2013