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
  Purpose

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.


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 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

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: 33
Study Start Date: January 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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.

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.
  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: NCT01451073

Locations
United States, Georgia
Atlanta, Georgia, United States, 30326
United States, Maryland
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston, Massachusetts, United States, 02116
United States, New York
New York City, New York, United States, 10016
United States, North Carolina
Raleigh, North Carolina, United States, 27609
United States, Texas
Houston, Texas, United States, 77056
Sponsors and Collaborators
Aderans Research Institute
  More Information

No publications provided

Responsible Party: Aderans Research Institute
ClinicalTrials.gov Identifier: NCT01451073     History of Changes
Other Study ID Numbers: CA-0002013
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 August 01, 2014