Study of Intradermal Injections of RCS-01 in Male and Female Subjects

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.

Conditions

• Intrinsic Aging of Skin
• Skin Wrinkling
• Solar Degeneration of Skin

Interventions

DRUG

RCS-01

Cultured, autologous hair follicle cells suspended in cryomedium

DRUG

Placebo

Cryomedium

DEVICE

Sham injection

skin penetration of the needle without injection of liquid

Sponsors & Collaborators

• JensonR+ Limited

  collaborator UNKNOWN

• PHARMALOG Institut für klinische Forschung GmbH

  collaborator UNKNOWN

• Syreon Corporation

  collaborator INDUSTRY

• Innovacell Biotechnologie AG

  collaborator INDUSTRY

• Datinf GmbH

  collaborator UNKNOWN

• RepliCel Life Sciences, Inc.

  lead INDUSTRY

Principal Investigators

• Alessandra Marini, MD · IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-10-10

Primary Completion

2017-07-12

Completion

2017-07-12

Countries

• Germany

Study Locations