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)

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669746
• Other study ID #: CA-0006931
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2012
• Last updated: July 9, 2013
• Start date: June 2012

Study information

• Verified date: July 2013
• Source: Aderans Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia
• Female Pattern Baldness
• Male Pattern Baldness

Intervention

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.

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Radiant Research, Inc.	Santa Rosa	California
United States	Radiant Research, Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Aderans Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hair number		24 weeks post-injection	No
Primary	Change from baseline in hair width		24 weeks post-injection	No
Primary	Time course of any treatment benefit		24 week post-injection	No