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| Name | Class |
|---|---|
| JensonR+ Limited | UNKNOWN |
| PHARMALOG Institut für klinische Forschung GmbH | UNKNOWN |
| Syreon Corporation | INDUSTRY |
| Innovacell Biotechnologie AG |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCS-01 | Experimental | Cultured, autologous hair follicle cells suspended in cryomedium |
|
| Placebo | Placebo Comparator | cryomedium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RCS-01 | Drug | Cultured, autologous hair follicle cells suspended in cryomedium |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of local adverse events | Within-patient comparison of the local (reported at treatment evaluation sites) adverse event profile between treatment evaluation sites treated with RCS-01 or placebo. The local adverse event profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events reported at the treatment evaluation sites. | 52 weeks after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Between-subject comparison of the systemic (not reported at treatment evaluation sites) adverse event profile between participants in the RCS-01 Subgroup versus Placebo Subgroup. | 52 weeks after first injection |
| Incidence of abnormalities in skin structure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Marini, MD | IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH | Düsseldorf | 40225 | Germany |
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| Label | URL |
|---|---|
| RepliCel Life Sciences, Inc. Website | View source |
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| INDUSTRY |
| Datinf GmbH | UNKNOWN |
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| Placebo |
| Drug |
Cryomedium |
|
| Sham injection | Device | skin penetration of the needle without injection of liquid |
|
A within-patient and between patient comparison of histology results from analyses performed on biopsies obtained from treatment evaluation sites. |
| 52 weeks after first injection |
| Incidence of changes in markers related to skin aging | Markers to be assessed include fibrillar collagen type I (COL 1A1, COL 1A2) and type III (COL 3A1), transforming growth factor beta1, connective tissue growth factor, matrix metalloproteinases 1, 3 and 9, tissue inhibitor of matrix metalloproteinase 1 and lumican . Incidence of changes within- and between-participants. | 12 weeks after first injection |