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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451125
First Posted: October 13, 2011
Last Update Posted: July 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aderans Research Institute
  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: Intervention Model: Single Group Assignment
Masking: Single (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:


Further study details as provided by Aderans Research Institute:

Primary Outcome Measures:
  • Change from baseline in hair number [ Time Frame: 51 weeks post-injection ]
  • Change from baseline in hair width [ Time Frame: 51 weeks post-injection ]
  • Time course of any treatment benefit [ Time Frame: 51 weeks post-injection ]

Secondary Outcome Measures:
  • Effect of minoxidil [ Time Frame: Week 12, 18, 24, 33 and 51 post-injection ]

Enrollment: 43
Study Start Date: May 2010
Primary Completion Date: March 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aderans Research Institute
ClinicalTrials.gov Identifier: NCT01451125     History of Changes
Other Study ID Numbers: CA-0004512
First Submitted: October 11, 2011
First Posted: October 13, 2011
Last Update Posted: July 11, 2013
Last Verified: July 2013

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