Histological Analysis of CelluJuve® Injections in the Brachium

NCT06930209 | Active Not Recruiting

• 1 other identifier: SPDR-2023-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male and Female Subjects

Keywords

Histological Analysis; Dermal Filler

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

CelluJuve®

EXPERIMENTAL

Device: CelluJuve®

Interventions

CelluJuve® DEVICE

CelluJuve® injected into upper brachium

CelluJuve®

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female volunteers of any race between 30 and 65 years of age.
• Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
• Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
• 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.
• Able to follow study instructions and complete all required visits.
• Signed ICF and Photographic Release.

You may not qualify if:

• Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
• Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
• Subjects with known prolonged bleeding times due to disease or ongoing regimen use of anticoagulants (e.g., warfarin).
• Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
• 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.
• 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.
• 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.
• Known history of malignancy (excluding non-melanoma skin cancer) within the past 3 years.
• 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.).
• Known history or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
• 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.
• Known history or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
• Known history of clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
• Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
• Unwilling to adhere to medication restrictions for the duration of the study

Sponsors & Collaborators

• Spiderwort Biotechnologies Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (1)

BioPharma Services Inc.

North York, Ontario, M9L3A2, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 16, 2025
• Study Start: March 28, 2025
• Primary Completion: July 15, 2025
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)