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

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

Interventions

OTHER

Human autologous hair follicle cells

Human autologous hair follicle cells suspended in cell medium

OTHER

Cell medium

Cell medium

Sponsors & Collaborators

• Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research)

  collaborator UNKNOWN

• PRA Health Sciences

  collaborator INDUSTRY

• Innovacell Biotechnologie AG

  collaborator INDUSTRY

• DatInf (Germany)

  collaborator UNKNOWN

• The Hair and Skin Research and Treatment Center

  collaborator UNKNOWN

• TrichoScience Innovations, Inc.

  lead INDUSTRY

Principal Investigators

• Nino Lortkipanidze, MD, PhD · Scientific Research Institute for Skin and Venereal Diseases

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-04-30

Completion

2017-02-23

Countries

• Georgia

Study Locations