Histological Analysis of CelluJuve® Injections in the Brachium

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Male and Female Subjects
• Intervention / Treatment: Device: CelluJuve®

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M9L3A2
      • Biopharma Services Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female volunteers of any race between 30 and 65 years of age.
2. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
3. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
4. Subjects willing to receive microbolus injections of CelluJuve® into the proximal medial aspect of the brachium of their non-dominant arm, and willing to have one 5-mm cutaneous punch biopsy taken from each injection site.
5. Able to follow study instructions and complete all required visits.
6. Signed ICF and Photographic Release.

Exclusion Criteria:

1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
2. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
3. Subjects with known prolonged bleeding times due to disease or ongoing regimen use of anticoagulants (e.g., warfarin).
4. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
5. Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic, or surgical therapy.
6. Known history of medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry.
7. Known history of allergic/anaphylactic reactions to any of the components of CelluJuve® including known sensitivity to cellulose, porcine gelatin, or to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
8. Known history of malignancy (excluding non-melanoma skin cancer) within the past 3 years.
9. Known history of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegener's disease, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.).
10. Known history or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
11. Known history or presence of severe chronic systemic diseases, including but not limited to, poorly controlled diabetes mellitus (all types), congestive heart failure, severe liver disease, severe kidney disease, and others as judged by the Investigator.
12. Known history or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
13. Known history of clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
14. Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
15. Unwilling to adhere to medication restrictions for the duration of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CelluJuve®	Device: CelluJuve®; CelluJuve® injected into upper brachium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological assessment of biopsies - general morphology	Assessment of general morphology (e.g., Masson's trichrome)	3 months
Histological assessment of biopsies - immunostaining	Assessment of immunostaining (e.g., collagen, elastin, etc.)	3 months
Histological assessment of biopsies - immunogenicity	Assessment of immunogenicity (e.g., inflammatory markers, cytokines, etc.)	3 months

Collaborators and Investigators

• Sponsor: Spiderwort Biotechnologies Inc.
• Collaborators: ethica Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dermal Filler; Histological Analysis
• Other Study ID Numbers: SPDR-2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No