Clinical trial NCT01451125: A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)
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 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: 43
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 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.


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.
* 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.

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:
measure: Effect of minoxidil
timeFrame: Week 12, 18, 24, 33 and 51 post-injection
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: St Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
Study officials:
References: