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A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

Information source: Aderans Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Intervention: Autologous cultured dermal and epidermal cells (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Aderans Research Institute

Summary

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

Clinical Details

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 and Synergy With Application of Topical Minoxidil

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change from baseline in hair number

Change from baseline in hair width

Time course of any treatment benefit

Secondary outcome: Effect of minoxidil

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

- Agree to abstain from use of any hair growth affecting oral or topical medication

including over the counter and herbal medications, finasteride or dutasteride during the course of this study (other than minoxidil as required in 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 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 (with the exception of minoxidil).

- 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 or treatment area.

- Prior surgery in the treatment and/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.

- Hypersensitivity to minoxidil or the ingredients in the topical solution or foam

formulations.

Locations and Contacts

Radiant Research, Inc., Birmingham, Alabama 35209, United States

Radiant Research, Inc., Tucson, Arizona 85710, United States

Radiant Research, Inc., Pinellas Park, Florida 33781, United States

Radiant Research, Inc., St Louis, Missouri 63141, United States

Additional Information

Starting date: May 2010
Last updated: July 9, 2013

Page last updated: August 23, 2015

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