Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers
At Visit 1 (Baseline), all subjects will receive injections (0.2mL bolus) of CelluJuve® into the proximal medial aspect of the brachium of their non dominant arm. The volume per microbolus of CelluJuve® into a single injection site is 0.2 mL. All injections will be performed using the same type/brand of 25G x 1/2" (0.50x13 mm) needle. One 5-mm punch biopsy will be taken from injection sites at 2 weeks, 1 month and 3 months. Punch biopsy samples will be fixed in formol before being frozen or dehydrated, impregnated in paraffin, and embedded. Prepared samples will then be cut into 4 µm sections and analyzed for general morphology, immunostaining, and immunogenicity. Analysis will be performed at the epidermis, papillary dermis, and lower reticular dermis depending on the extracellular matrix component of interest. Safety will be assessed through AE reporting, study diaries, and concomitant medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
CelluJuve® injected into upper brachium
BioPharma Services Inc.
North York, Ontario, Canada
Histological assessment of biopsies - general morphology
Assessment of general morphology (e.g., Masson's trichrome)
Time frame: 3 months
Histological assessment of biopsies - immunostaining
Assessment of immunostaining (e.g., collagen, elastin, etc.)
Time frame: 3 months
Histological assessment of biopsies - immunogenicity
Assessment of immunogenicity (e.g., inflammatory markers, cytokines, etc.)
Time frame: 3 months
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