A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01451151
• Date of registration: 11/10/2011
• Primary sponsor: Aderans Research Institute
• Public title: A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004542)
• Scientific title: A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells Into the Hair Loss Area of the Scalp of Subjects
• Date of first enrolment: December 2010
• Target sample size: 33
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01451151
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.

- 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.

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.

- Paricipation 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 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 areas.

- Prior surgery in the donor 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Androgenetic Alopecia

Female Pattern Baldness

Male Pattern Baldness

Intervention(s)

Biological: Autologous cultured dermal and epidermal cells

Primary Outcome(s)

Change from baseline in hair number [Time Frame: 51 weeks post-injection]

Change from baseline in hair width [Time Frame: 51 weeks post-injection]

Time course of any treatment benefit [Time Frame: 51 weeks post-injection]

Secondary ID(s)

CA-0004542

Source(s) of Monetary Support

Please refer to primary and secondary sponsors