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A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)

Primary Purpose

Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous cultured dermal and epidermal cells
Sponsored by
Aderans Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Change from baseline in hair number
Change from baseline in hair width
Time course of any treatment benefit

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
February 28, 2012
Sponsor
Aderans Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01451047
Brief Title
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)
Official Title
A Phase 2 Randomized 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 Balding Scalp of Subjects With Hair Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aderans Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness
Keywords
Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Autologous cultured dermal and epidermal cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in hair number
Time Frame
51 weeks post-injection
Title
Change from baseline in hair width
Time Frame
51 weeks post-injection
Title
Time course of any treatment benefit
Time Frame
51 weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30326
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
City
New York City
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States

12. IPD Sharing Statement

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A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)

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