Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia
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.
Other: Human autologous hair follicle cells
Other: Cell medium
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Incidence of local adverse events [ Time Frame: six months post-injection ] [ Designated as safety issue: Yes ]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
- Incidence of local adverse events [ Time Frame: 12, 24 and 60 months post-injection ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Histopathological analysis [ Time Frame: 6, 12. 24 and 60 months post-injection ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||October 2016|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
Other: Human autologous hair follicle cells
Human autologous hair follicle cells suspended in cell medium
Other Names:Other: Cell medium
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286649
|Scientific Research Institute for Skin and Venereal Diseases, Department of Dermatology|
|Tbilisi, Georgia, 0112|
|Principal Investigator:||Nino Lortkipanidze, MD, PhD||Scientific Research Institute for Skin and Venereal Diseases|