NCT06930209

Histological Analysis of CelluJuve® Injections in the Brachium

Histological Analysis of CelluJuve® Injected Into the Brachium of Healthy Volunteers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Spiderwort Biotechnologies Inc. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers

Detailed description

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.

Conditions

• Healthy Male and Female Subjects

Interventions

Type	Name	Description
DEVICE	CelluJuve®	CelluJuve® injected into upper brachium

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-07-15
• Completion: 2027-04-15
• First posted: 2025-04-16
• Last updated: 2025-04-20

Locations

1 site across 1 country: Canada