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

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ClinicalTrials.gov Identifier: NCT01286649
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : March 8, 2017
Sponsor:
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
Information provided by (Responsible Party):
RepliCel Life Sciences, Inc. ( TrichoScience Innovations, Inc. )

Tracking Information
First Submitted Date  ICMJE January 18, 2011
First Posted Date  ICMJE January 31, 2011
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
Incidence of local adverse events [ Time Frame: six months post-injection ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
Incidence of local adverse events [ Time Frame: six months post-injection ]
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to placebo as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Change History Complete list of historical versions of study NCT01286649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • Incidence of local adverse events [ Time Frame: 12, 24 and 60 months post-injection ]
    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 [ Time Frame: during 60-month observation period ]
  • Histopathological analysis [ Time Frame: 6, 12. 24 and 60 months post-injection ]
    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 [ Time Frame: during 60-month observation period ]
    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 [ Time Frame: 6 months post-injection and over 24-month observation period ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
  • Incidence of local adverse events [ Time Frame: 12 and 24 months post-injection ]
    Local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at 24 months compared to placebo, defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
  • Systemic adverse events [ Time Frame: during 24-month observation period ]
  • Histopathological analysis [ Time Frame: 6, 12 and 24 months post-injection ]
    Biopsies taken from treatment areas injected with verum and placebo from two male and two female patients (selected at random). 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 [ Time Frame: during 24-month observation period ]
    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 [ Time Frame: 6 months post-injection and over 24-month observation period ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Other: Human autologous hair follicle cells
    Human autologous hair follicle cells suspended in cell medium
    Other Names:
    • autologous hair follicle cells
    • hair follicle cells
    • verum
  • Other: Cell medium
    Cell medium
    Other Names:
    • control
    • placebo
    • cell transportation medium
Study Arms  ICMJE Injection of verum and control
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.
Interventions:
  • Other: Human autologous hair follicle cells
  • Other: Cell medium
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2011)
20
Actual Study Completion Date  ICMJE February 23, 2017
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286649
Other Study ID Numbers  ICMJE TS001-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RepliCel Life Sciences, Inc. ( TrichoScience Innovations, Inc. )
Study Sponsor  ICMJE TrichoScience Innovations, Inc.
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Nino Lortkipanidze, MD, PhD Scientific Research Institute for Skin and Venereal Diseases
PRS Account RepliCel Life Sciences, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP