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

NCT01451021 | Completed Phase 2

• 1 other identifier: CA-0002011
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO 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

Outcome Measures

Primary Outcomes (3)

• Change from baseline in hair number

  51 weeks post-injection

• Change from baseline in hair width

  51 weeks post-injection

• Time course of any treatment benefit

  51 weeks post-injection

Interventions

Autologous cultured dermal and epidermal cells BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aderans Research Institute: lead

Study Sites (3)

Unknown Facility

Boston, Massachusetts, 02116, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Houston, Texas, 77056, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: October 13, 2011
• Study Start: October 1, 2008
• Primary Completion: June 1, 2010
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

US (3)