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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01451112
Other study ID # CA-0002899
Secondary ID
Status Completed
Phase Phase 2
First received October 11, 2011
Last updated July 9, 2013
Start date August 2009

Study information

Verified date July 2013
Source Aderans Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

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


Intervention

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.

Locations

Country Name City State
United States Virginia Clinical Research Norfolk Virginia
United States TKL Research Paramus New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Aderans Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in hair number 51 weeks post-injection No
Primary Change from baseline in hair width 51 weeks post-injection No
Primary Time course of any treatment benefit 51 weeks post-injection No
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