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Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Phase 1
Locations
Georgia
Study Type
Interventional
Intervention
Human autologous hair follicle cells
Cell medium
Sponsored by
TrichoScience Innovations, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Alopecia, Alopecia, Androgenetic, Androgenetic Alopecia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female between the age of 18 and 55 years and in good health having evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp. Female patients with androgenetic alopecia (AGA) characterized as vertex pattern type II or type III of the Ludwig Scale qualify for inclusion in this study. Males with androgenetic alopecia (AGA) involving the vertex area of the scalp, characterized as type III vertex- type VI on the Norwood Scale qualify for inclusion in the study.
  2. Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
  3. The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
  4. Willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
  5. Females must be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control. This method of contraception must be used at least 4 weeks prior to and during the entire duration of the clinical trial.

Exclusion Criteria:

  1. Use of any product (medication or otherwise) which interferes with the hair growth cycle.
  2. Any systemic medical treatment for hair loss (for example, Finasteride, Minoxidil, Dutasteride, or antiandrogens) within the last 12 months.
  3. Start of contraception treatments containing chlormadinone or cyproterone acetate within the last 12 months.
  4. Women who are pregnant or nursing.
  5. Presence of any medical condition that influences the hair growth cycle (for example, alopecia areata, lichen planopilaris, lupus erythematosus, severe seborrheic eczema, psoriasis capitis or tinea capitis, untreated thyroid gland disease/goiter development, auto-immune diseases, etc.).
  6. Any condition that, in the investigator's opinion would impact patient safety and/or a patient's ability to complete all study related procedures (for example, psychiatric illness, drug addiction, alcoholism, etc.).
  7. Infection with human immunodeficiency virus (HIV), hepatitis, or syphilis.
  8. Subjects diagnosed with cancer with or without chemotherapy treatment.
  9. Sudden hair loss within the last 4 months unrelated to normal seasonal hair shedding or androgenetic alopecia (AGA).
  10. Subjects in the process of or having completed surgical correction of hair loss in the past 24 months.
  11. Participation in a cosmetic and/or pharmaceutical research study.

Sites / Locations

  • Scientific Research Institute for Skin and Venereal Diseases, Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Injection of verum and control

Arm Description

Patients will receive randomized, blinded, injections of BOTH autologous hair follicle cells in medium (verum) and of medium alone (control) into two separate pre-defined treatment areas on their scalp.

Outcomes

Primary Outcome Measures

Incidence of local adverse events
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to control as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness

Secondary Outcome Measures

Incidence of local adverse events
Local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at 60 months compared to control, defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Systemic adverse events
Histopathological analysis
Biopsies are taken from treatment areas injected with verum and control from two male and two female patients (selected at random) at 6, 12, and 24 months post-injection. All patients not previously providing biopsies will do so 60 months post-injection. Biopsies sent to a blinded independent evaluator who will perform microscopic analysis of sections of the biopsies and provide reports detailing the difference between the biopsies of the two treatment areas per patient.
Complete safety profile
Analysis of the complete safety profile of study participants. Number and type of adverse events (AEs) will be listed per patient and as will reports from the patients selected to provide biopsies for histopathological analysis.
Hair Growth
Hair growth will be assessed subjectively and objectively via a series of digital images taken from the scalp using standardized equipment. The following images will be taken: global scalp image pre shaving, global scalp image post-shaving (at select visits only), macroscopic images of each injection sites.

Full Information

First Posted
January 18, 2011
Last Updated
March 6, 2017
Sponsor
TrichoScience Innovations, Inc.
Collaborators
Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research), PRA Health Sciences, Innovacell Biotechnologie AG, DatInf (Germany), The Hair and Skin Research and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT01286649
Brief Title
Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia
Official Title
Randomized, Single-centre, Double-blind, Placebo-controlled, Phase I / IIa Study to Evaluate the Safety and Efficacy of Human Autologous Hair Follicle Dermal Sheath Cup Cells (DSCC) in Women and Men With Androgenetic Alopecia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TrichoScience Innovations, Inc.
Collaborators
Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research), PRA Health Sciences, Innovacell Biotechnologie AG, DatInf (Germany), The Hair and Skin Research and Treatment Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth. 20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales. At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Alopecia, Alopecia, Androgenetic, Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection of verum and control
Arm Type
Other
Arm Description
Patients will receive randomized, blinded, injections of BOTH autologous hair follicle cells in medium (verum) and of medium alone (control) into two separate pre-defined treatment areas on their scalp.
Intervention Type
Other
Intervention Name(s)
Human autologous hair follicle cells
Other Intervention Name(s)
autologous hair follicle cells, hair follicle cells, verum
Intervention Description
Human autologous hair follicle cells suspended in cell medium
Intervention Type
Other
Intervention Name(s)
Cell medium
Other Intervention Name(s)
control, placebo, cell transportation medium
Intervention Description
Cell medium
Primary Outcome Measure Information:
Title
Incidence of local adverse events
Description
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to control as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Time Frame
six months post-injection
Secondary Outcome Measure Information:
Title
Incidence of local adverse events
Description
Local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at 60 months compared to control, defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Time Frame
12, 24 and 60 months post-injection
Title
Systemic adverse events
Time Frame
during 60-month observation period
Title
Histopathological analysis
Description
Biopsies are taken from treatment areas injected with verum and control from two male and two female patients (selected at random) at 6, 12, and 24 months post-injection. All patients not previously providing biopsies will do so 60 months post-injection. Biopsies sent to a blinded independent evaluator who will perform microscopic analysis of sections of the biopsies and provide reports detailing the difference between the biopsies of the two treatment areas per patient.
Time Frame
6, 12. 24 and 60 months post-injection
Title
Complete safety profile
Description
Analysis of the complete safety profile of study participants. Number and type of adverse events (AEs) will be listed per patient and as will reports from the patients selected to provide biopsies for histopathological analysis.
Time Frame
during 60-month observation period
Title
Hair Growth
Description
Hair growth will be assessed subjectively and objectively via a series of digital images taken from the scalp using standardized equipment. The following images will be taken: global scalp image pre shaving, global scalp image post-shaving (at select visits only), macroscopic images of each injection sites.
Time Frame
6 months post-injection and over 24-month observation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between the age of 18 and 55 years and in good health having evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp. Female patients with androgenetic alopecia (AGA) characterized as vertex pattern type II or type III of the Ludwig Scale qualify for inclusion in this study. Males with androgenetic alopecia (AGA) involving the vertex area of the scalp, characterized as type III vertex- type VI on the Norwood Scale qualify for inclusion in the study. Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol. The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation or scars that may confound study results. Willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study. Females must be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control. This method of contraception must be used at least 4 weeks prior to and during the entire duration of the clinical trial. Exclusion Criteria: Use of any product (medication or otherwise) which interferes with the hair growth cycle. Any systemic medical treatment for hair loss (for example, Finasteride, Minoxidil, Dutasteride, or antiandrogens) within the last 12 months. Start of contraception treatments containing chlormadinone or cyproterone acetate within the last 12 months. Women who are pregnant or nursing. Presence of any medical condition that influences the hair growth cycle (for example, alopecia areata, lichen planopilaris, lupus erythematosus, severe seborrheic eczema, psoriasis capitis or tinea capitis, untreated thyroid gland disease/goiter development, auto-immune diseases, etc.). Any condition that, in the investigator's opinion would impact patient safety and/or a patient's ability to complete all study related procedures (for example, psychiatric illness, drug addiction, alcoholism, etc.). Infection with human immunodeficiency virus (HIV), hepatitis, or syphilis. Subjects diagnosed with cancer with or without chemotherapy treatment. Sudden hair loss within the last 4 months unrelated to normal seasonal hair shedding or androgenetic alopecia (AGA). Subjects in the process of or having completed surgical correction of hair loss in the past 24 months. Participation in a cosmetic and/or pharmaceutical research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nino Lortkipanidze, MD, PhD
Organizational Affiliation
Scientific Research Institute for Skin and Venereal Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific Research Institute for Skin and Venereal Diseases, Department of Dermatology
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia

12. IPD Sharing Statement

Links:
URL
http://www.replicel.com/
Description
RepliCel Life Sciences, Inc. Website (Parent Co. of TrichoScience Innovations, Inc.)

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Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia

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