Androgenetic Alopecia Clinical Trial
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.
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.
n/a
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