Study of Intradermal Injections of RCS-01 in Male and Female Subjects
NCT ID: NCT02391935
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2015-10-10
2017-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
Placebo
Cryomedium
Sham injection
skin penetration of the needle without injection of liquid
Placebo
cryomedium
Placebo
Cryomedium
Sham injection
skin penetration of the needle without injection of liquid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
Placebo
Cryomedium
Sham injection
skin penetration of the needle without injection of liquid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Female subjects must be post-menopausal for at least one year or surgically sterile.
3. Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.
4. The treatment evaluation sites are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
Exclusion Criteria
2. Subjects diagnosed with psoriasis, lichen planus, vitiligo, systemic scleroderma, or lupus erythematosus.
3. Any condition that, in the investigator's opinion, would impact subject's safety and/or a subject's ability to complete all study related procedures.
4. History of infection with or positive serology results for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
5. Presence/history of hypertrophic scars and/or keloids.
6. Subjects diagnosed with cancer with or without chemotherapy treatment within 3 years prior enrollment.
7. Women who are pregnant or nursing.
8. Current use of any medications not permitted in the study
9. Ongoing or recent participation in a cosmetic and/or clinical research study prior to enrolment.
10. Subject not agreeing to avoid UV exposure (sun, solarium) on the nude buttocks during the study period.
11. Known allergy or hypersensitivity to human serum albumin, DMSO, gentamicin, material of bovine origin and/or local anesthetics.
12. Close affiliation with the investigational site (e.g., a close relative of the investigator or a possibly dependent person (e.g., employee or student of the investigational site)).
13. Subjects diagnosed with coagulopathies or significant thrombocytopenia
50 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
JensonR+ Limited
UNKNOWN
PHARMALOG Institut für klinische Forschung GmbH
UNKNOWN
Syreon Corporation
INDUSTRY
Innovacell Biotechnologie AG
INDUSTRY
Datinf GmbH
UNKNOWN
RepliCel Life Sciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alessandra Marini, MD
Role: PRINCIPAL_INVESTIGATOR
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
Düsseldorf, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
RepliCel Life Sciences, Inc. Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RCS-01-001-2014
Identifier Type: -
Identifier Source: org_study_id