Clinical trial NCT01451073: A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)
Official title: 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 (Same Day as Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Male Pattern Baldness
Female Pattern Baldness
Keywords: Androgenetic Alopecia
Male Pattern Baldness
Female Pattern Baldness
Hair Loss
Baldness
Lead sponsor: Aderans Research Institute
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the ability of injections Ji Gami(TM) to induce hair growth in male and female subjects with hair loss.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in hair number
timeFrame: 51 weeks post-injection
measure: Change from baseline in hair width
timeFrame: 51 weeks post-injection
measure: Time course of any treatment benefit
timeFrame: 51 weeks post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
city: Chevy Chase
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: New York City
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
Study officials:
References: