Healthy Male and Female SubjectsNCT06930209
Histological Analysis of CelluJuve® Injections in the Brachium
A study testing CelluJuve® in people with Healthy Male and Female Subjects, run by Spiderwort Biotechnologies Inc. at 1 site in Canada.
Trial summary
Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Subjects
- What is being tested?
- CelluJuve®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- CelluJuve®
- Keywords
- Histological Analysis, Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelluJuve®Device
CelluJuve® injected into upper brachium
| Study group | Role | What they receive |
|---|---|---|
| CelluJuve® | Experimental | Not described Receives: Device: CelluJuve® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological assessment of biopsies - general morphology
Assessment of general morphology (e.g., Masson's trichrome)
Measured: 3 months
Histological assessment of biopsies - immunostaining
Assessment of immunostaining (e.g., collagen, elastin, etc.)
Measured: 3 months
Histological assessment of biopsies - immunogenicity
Assessment of immunogenicity (e.g., inflammatory markers, cytokines, etc.)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start28 Mar 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spiderwort Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930209
- Sponsor's protocol ID
- SPDR-2023-002
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Analysis of CelluJuve® Injected Into the Brachium of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06930209
- Acronym / sponsor ID
- SPDR-2023-002
- Conditions
- Healthy Male and Female Subjects
- Keywords
- Histological Analysis, Dermal Filler
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Spiderwort Biotechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CelluJuve® | Experimental | Device: CelluJuve® |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelluJuve®CelluJuve® injected into upper brachium | Device | CelluJuve® |
Primary outcome
Histological assessment of biopsies - general morphology
Time frame: 3 months
Assessment of general morphology (e.g., Masson's trichrome)
Histological assessment of biopsies - immunostaining
Time frame: 3 months
Assessment of immunostaining (e.g., collagen, elastin, etc.)
Histological assessment of biopsies - immunogenicity
Time frame: 3 months
Assessment of immunogenicity (e.g., inflammatory markers, cytokines, etc.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CelluJuve® in people with Healthy Male and Female Subjects, run by Spiderwort Biotechnologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological assessment of biopsies - general morphology (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.