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)

NCT ID: NCT01669746

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

Brief Summary

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

Conditions

Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Study Design

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

Study Groups

Treatment

Group Type: EXPERIMENTAL

Autologous cultured mixed population of dermal cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aderans Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radiant Research, Inc.

Tucson, Arizona, United States

Radiant Research, Inc.

Santa Rosa, California, United States

Radiant Research, Inc.

Denver, Colorado, United States

Radiant Research, Inc.

Pinellas Park, Florida, United States

Radiant Research, Inc.

Akron, Ohio, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Radiant Research, Inc.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CA-0006931

Identifier Type: -

Identifier Source: org_study_id