Bovine Atelocollagen Skin Sensitization Test

Overseen By Stefan M Lemperle, MD, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AscentX Medical, Inc.

Must not be taking: Immuno-suppressants, Cortico-steroids

Disqualifiers: Pregnancy, Skin disease, Immuno-suppressants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on any systemic immuno-suppressive therapy or topical treatments on your arms, you may not be eligible if you've used them in the past 3 months.

What data supports the effectiveness of the treatment Bovine Atelocollagen?

Research shows that atelocollagen can help with wound healing in various contexts, such as in dog corneas and cleft palate repair in rabbits, by enhancing tissue repair and reducing scar formation. Additionally, it has been used as a carrier for medications in gene therapy due to its low risk of causing immune reactions. ^{1 2 3 4 5}

Is Bovine Atelocollagen safe for human use?

There is no specific safety data available for Bovine Atelocollagen in the provided research articles. ^{6 7 8 9 10}

How does the treatment Bovine Atelocollagen differ from other treatments for this condition?

Bovine Atelocollagen is unique because it involves the use of collagen, a protein that provides structure to various tissues, which may aid in tissue repair and regeneration. Unlike other treatments, it may leverage the natural properties of collagen to support healing processes. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial involves injecting cow-derived collagen into the skin of healthy adults to check for allergic reactions. The goal is to see if their immune system reacts negatively, which would indicate an allergy.

Research Team

Peter Rullan, MD

Principal Investigator

Dermatology Institute

Eligibility Criteria

Inclusion Criteria

Subjects willing and able to comply with the follow-up requirements.

Subjects willing and able to give written and verbal informed consent.

Volunteers must be capable of understanding and following directions in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intradermal injections of atelocollagen on Day 01 and Day 15

2 weeks

2 visits (in-person)

Follow-up

Final assessment of injection sites and monitoring for hypersensitivity reactions

30 days

1 visit (in-person)

Treatment Details

Interventions

• Bovine Atelocollagen

Participant Groups

Group I: Bovine Atelocollagen Skin Sensitization Test Experimental Treatment 1 Intervention

Volunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen.

Who Is Running the Clinical Trial?

AscentX Medical, Inc.

Lead Sponsor

Trials

1

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Atelocollagen as a potential carrier of therapeutics]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Maxillary growth following atelocollagen implantation on mucoperiosteal denudation of the palatal process in young rabbits: implications for clinical cleft palate repair. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Radiographic comparison of atelocollagen versus deproteinized bovine bone minerals covered with a collagen membrane in alveolar ridge preservation: a retrospective study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A preliminary study of direct application of atelocollagen into a wound lesion in the dog cornea. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Atelocollagen to Inhibit Fibrotic Proliferation in Tenon Tissue: in vitro study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Characterizing the coverage of critical effects relevant in the safety evaluation of food additives by AOPs. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Examination of the biological safety of a drug derived from mammalian organs. [2013]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2015]. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

The use of adverse outcome pathways in the safety evaluation of food additives. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The isolation of collagen-associated proteoglycan from bovine nasal cartilage and its preferential interaction with alpha2 chains of type I collagen. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Immunoelectron microscopic localization of Collagen type XV during human mesenchymal stem cells mineralization. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Collagen biosynthesis: synthesis and secretion of a high molecular weight collagen precursor (procollagen). [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Collagen XV, a multifaceted multiplexin present across tissues and species. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Refinement of collagen-mineral interaction: a possible role for osteocalcin in apatite crystal nucleation, growth and development. [2022]