A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

Androgenetic Alopecia Clinical Trial

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 vs Dermal Cells Into the Hair Loss Area of the Scalp of Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451138
• Other study ID #: CA-0004541
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2011
• Last updated: July 9, 2013
• Start date: November 2010

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

The purpose of this study is to evaluate the ability of injections of Ji Gami(TM) N and Ji Gami(TM) NDO to induce hair growth in male and female subjects with hair loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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 dermal and epidermal cells
A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. 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.	Birmingham	Alabama
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Radiant Research, Inc.	St Louis	Missouri
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		51 weeks post-injection	No
Primary	Change from baseline in hair width		51 weeks post-injection	No
Primary	Time course of any treatment benefit		51 weeks post-injection	No