Study of Intradermal Injections of RCS-01 in Male and Female Subjects
Status:
Completed
Trial end date:
2017-07-12
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to assess the safety profile of RCS-01 injections as
compared to placebo injections. This study will also measure the impact these injections will
have on skin markers related to aging through evaluation of gene expression profiles.
30 participants will be selected for this study based on their health status, current/past
medications, and ability to adhere to protocol-related requirements. At the first visit and
after providing informed consent, participants are evaluated against the study
inclusion/exclusion criteria and provide blood samples for screening assessments (including
virology). If suitable for study participation, participants will provide a biopsy from the
scalp from which RCS-01 will be prepared and will have four treatment evaluation sites
identified on their buttocks, two on each side.
Study participants will be randomized to one of two treatment subgroups. Participants in the
RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a
needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n=
6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on
their buttocks will be performed before receipt of injections at Day 0. In addition to
injections delivered at Day 0, the pre-selected treatment evaluation sites will receive
intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and
eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3)
injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up
period to monitor long-term safety. At the 12-week time point, 18 randomly-selected
participants from the RCS-01 Subgroup will provide biopsies from all injection sites for
analysis of skin markers related to aging. At the 26-week time point, the remaining
participants will provide biopsies of all injection sites for histopathological analysis.
Phase:
Phase 1
Details
Lead Sponsor:
RepliCel Life Sciences, Inc.
Collaborators:
Datinf GmbH Innovacell Biotechnologie AG JensonR+ Limited PHARMALOG Institut für klinische Forschung GmbH Syreon Corporation