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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Aderans Research Institute

ClinicalTrials.gov Identifier:

NCT01451125

First received: October 11, 2011

Last updated: February 28, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 11, 2011
Last Updated Date	February 28, 2012
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2011)	Change from baseline in hair number [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ] Change from baseline in hair width [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ] Time course of any treatment benefit [ Time Frame: 51 weeks post-injection ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01451125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 12, 2011)	Effect of minoxidil [ Time Frame: Week 12, 18, 24, 33 and 51 post-injection ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Androgenetic Alopecia Male Pattern Baldness Female Pattern Baldness
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	43
Completion Date	Not Provided
Estimated Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01451125
Other Study ID Numbers ^ICMJE	CA-0004512
Has Data Monitoring Committee	No
Responsible Party	Aderans Research Institute
Study Sponsor ^ICMJE	Aderans Research Institute
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Aderans Research Institute
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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