A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451177
First received: October 11, 2011
Last updated: July 9, 2013
Last verified: July 2013

October 11, 2011
July 9, 2013
May 2010
January 2012   (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 NCT01451177 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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-0004669)
A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of Cultured Occipital Autologous Dermal and Epidermal Cells vs Dermal Cells, Where Cells Are Expanded ex Vivo From Plucked Scalp, Into the Hair Loss Area of the Scalp of Subjects.

Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo from scalp, 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
A piece of occipital scalp, plucked of hairs prior to excision, 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. The cells are then injected into the balding area of the scalp of the original subject.
Experimental: Treated
Intervention: Biological: Autologous cultured dermal and epidermal cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Not Provided
January 2012   (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.
  • 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.
  • 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 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
 
NCT01451177
CA-0004669
No
Aderans Research Institute
Aderans Research Institute
Not Provided
Not Provided
Aderans Research Institute
July 2013

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