A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)

NCT ID: NCT01451073

Last Updated: 2012-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

Brief Summary

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

Conditions

Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Keywords

Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Autologous cultured dermal and epidermal cells

Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.

Intervention Type: BIOLOGICAL

Eligibility 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.
• Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

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.
• Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
• Any 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.
• Dermatologic condition in donation and/or study areas.
• Prior surgery in the treatment area.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aderans Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atlanta, Georgia, United States

Chevy Chase, Maryland, United States

Boston, Massachusetts, United States

New York, New York, United States

Raleigh, North Carolina, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

CA-0002013

Identifier Type: -

Identifier Source: org_study_id