A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995)
A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells Into the Hair Loss Area of the Scalp of Subjects
1 other identifier
interventional
88
1 country
9
Brief Summary
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedJuly 11, 2013
July 1, 2013
1.7 years
October 11, 2011
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in hair number
51 weeks post-injection
Change from baseline in hair width
51 weeks post-injection
Time course of any treatment benefit
51 weeks post-injection
Study Arms (1)
Treated
EXPERIMENTALInterventions
A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
Eligibility Criteria
You may qualify if:
- 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.
- Able to provide informed consent after risks and benefits of the study have been explained.
- Be willing to undergo all study procedures.
- Ability to communicate effectively with study personnel.
- Have no clinically significant disease or abnormal laboratory evaluations 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.
You may not qualify if:
- 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.
- Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
- Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
- 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.
- Clinically significant dermatologic condition in donation or study areas.
- Prior surgery in the donor 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Axis Clinical Trials, Inc.
Los Angeles, California, 90036, United States
Radiant Research, Inc.
Santa Rosa, California, 95405, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Axis Clinical Trials
New Hyde Park, New York, 11042, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Radiant Research, Inc
Greer, South Carolina, 29651, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 13, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2013
Last Updated
July 11, 2013
Record last verified: 2013-07