A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness	Biological: Autologous cultured mixed population of dermal cells	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Intervention Model:	Single Group Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of ex Vivo-cultured, Expanded, Occipital Autologous Dermal and Epidermal Cells, Injected Into the Hair Loss Area of the Scalp of Male and Female Subjects With Alopecia
Study Start Date :	June 2012
Actual Primary Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Treatment	Biological: Autologous cultured mixed population of dermal 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.

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in hair number [ Time Frame: 24 weeks post-injection ]
2. Change from baseline in hair width [ Time Frame: 24 weeks post-injection ]
3. Time course of any treatment benefit [ Time Frame: 24 week post-injection ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Male and female volunteers 18-50 years old, inclusive.
• Women of childbearing potential must use an adequate form of contraception during study participation.
• Hair loss consistent with Grade III-Vertex, IV, or V based on the based on the Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle, or class 1 or class 2 based on the Ludwig scale.
• 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; also agrees to abstain from shaving the head during the course of the study.

Exclusion Criteria:

• Women who are pregnant or lactating.
• 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 symptoms of any acute illness within 30 days prior to excision day.
• Any condition that compromises the ability to understand or comply with study requirements.
• 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 zones.
• Prior surgery in the donor or study zones.
• 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
United States, California
Radiant Research, Inc.
Santa Rosa, California, United States, 95405
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Florida
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
United States, Ohio
Radiant Research, Inc.
Akron, Ohio, United States, 44311
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
United States, Texas
Radiant Research, Inc.
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Aderans Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Aderans Research Institute
ClinicalTrials.gov Identifier:	NCT01669746 History of Changes
Other Study ID Numbers:	CA-0006931
First Posted:	August 21, 2012
Last Update Posted:	July 11, 2013
Last Verified:	July 2013

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