- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451190
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)
July 9, 2013 updated by: Aderans Research Institute
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
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
-
Tucson, Arizona, United States, 85710
- Radiant Research, Inc.
-
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California
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Los Angeles, California, United States, 90036
- Axis Clinical Trials, Inc.
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Santa Rosa, California, United States, 95405
- Radiant Research, Inc.
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Colorado
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Denver, Colorado, United States, 80239
- Radiant Research, Inc.
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Florida
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Pinellas Park, Florida, United States, 33781
- Radiant Research, Inc.
-
-
Missouri
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St Louis, Missouri, United States, 63141
- Radiant Research, Inc.
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New York
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New Hyde Park, New York, United States, 11042
- Axis Clinical Trials
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Ohio
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Akron, Ohio, United States, 44311
- Radiant Research, Inc.
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South Carolina
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Greer, South Carolina, United States, 29651
- Radiant Research, Inc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- 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.
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treated
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in hair number
Time Frame: 51 weeks post-injection
|
51 weeks post-injection
|
Change from baseline in hair width
Time Frame: 51 weeks post-injection
|
51 weeks post-injection
|
Time course of any treatment benefit
Time Frame: 51 weeks post-injection
|
51 weeks post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 12, 2011
First Posted (ESTIMATE)
October 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
July 11, 2013
Last Update Submitted That Met QC Criteria
July 9, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA-0005995
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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