A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)
This study is ongoing, but not recruiting participants.
Sponsor:
Aderans Research Institute
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01451151
First received: October 11, 2011
Last updated: February 28, 2012
Last verified: February 2012
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Purpose
The purpose of the the study is to evaluate the ability of injections of Ji Gami(TM) C 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 Study to Evaluate and Compare the Efficacy of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells Into the Hair Loss Area of the Scalp of Subjects |
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: | December 2010 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: Autologous cultured dermal and epidermal cells
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| 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.
- 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.
- Paricipation 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451151
Locations
| United States, California | |
| Axis Clinical Trials, Inc. | |
| Los Angeles, California, United States, 90036 | |
| United States, New York | |
| Axis Clinical Trials, Inc. | |
| New Hyde Park, New York, United States, 11042 | |
Sponsors and Collaborators
Aderans Research Institute
More Information
No publications provided
| Responsible Party: | Aderans Research Institute |
| ClinicalTrials.gov Identifier: | NCT01451151 History of Changes |
| Other Study ID Numbers: | CA-0004542 |
| 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 June 18, 2013