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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-0002013)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451073
First received: October 11, 2011
Last updated: February 28, 2012
Last verified: February 2012

October 11, 2011
February 28, 2012
January 2009
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01451073 on ClinicalTrials.gov Archive Site
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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-0002013)
A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of a 1 Time Injection vs. Repeat Injections of ex Vivo Expanded Cultured Autologous Occipital Dermal and Epidermal Cells (Same Day as Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Androgenetic Alopecia
  • Male Pattern Baldness
  • Female Pattern Baldness
Biological: Autologous cultured dermal and epidermal cells
Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
August 2010   (final data collection date for primary outcome measure)

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.

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.
  • 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 and/or study areas.
  • Prior surgery in the treatment area.
  • 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01451073
CA-0002013
No
Aderans Research Institute
Aderans Research Institute
Not Provided
Not Provided
Aderans Research Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP