Trial | NCT01451021  Report issue

Title

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss
A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of a 1 Time Injection vs. Repeat Injections of ex Vivo Expanded Cultured Autologous Occipital Dermal and Epidermal Cells (Day After Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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.
Study Started
Oct 31
2008
Primary Completion
Jun 30
2010
Last Update
Feb 29
2012
Estimate

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.

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.
No Results Posted