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

NCT01286649 | Completed Phase 1

• 1 other identifier: TS001-2009
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

Alopecia; Alopecia, Androgenetic; Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• 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

  six months post-injection

Secondary Outcomes (5)

• Incidence of local adverse events

  12, 24 and 60 months post-injection

• Systemic adverse events

  during 60-month observation period

• Histopathological analysis

  6, 12. 24 and 60 months post-injection

• Complete safety profile

  during 60-month observation period

• Hair Growth

  6 months post-injection and over 24-month observation period

Study Arms (1)

Injection of verum and control

OTHER

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.

Other: Human autologous hair follicle cells; Other: Cell medium

Interventions

Human autologous hair follicle cells OTHER

Human autologous hair follicle cells suspended in cell medium

Also known as: autologous hair follicle cells, hair follicle cells, verum

Injection of verum and control

Cell medium OTHER

Cell medium

Also known as: control, placebo, cell transportation medium

Injection of verum and control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TrichoScience Innovations, Inc.: lead
• Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research): collaborator
• PRA Health Sciences: collaborator
• Innovacell Biotechnologie AG: collaborator
• DatInf (Germany): collaborator
• The Hair and Skin Research and Treatment Center: collaborator

Study Sites (1)

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

Tbilisi, 0112, Georgia

Location

Related Links

• RepliCel Life Sciences, Inc. Website (Parent Co. of TrichoScience Innovations, Inc.)

MeSH Terms

Conditions

Alopecia

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nino Lortkipanidze, MD, PhD

  Scientific Research Institute for Skin and Venereal Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 31, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: February 23, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

GE (1)