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Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold.

Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark"Collagen Scaffold.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001157460
Enrollment
19
Registered
2016-08-25
Start date
2016-12-20
Completion date
2020-04-23
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

CelGro "Registered Trademark is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens. Treatment of injuries to peripheral nerves is a challenging surgical issue. The primary aim of surgical repair is to guide regenerating axons correctly into place in the distal nerve, with minimal loss of nerve fibres at the site of repair. This results in reinnervation of distal tissues, and restores autonomic, sensory and motor function. Direct, tensionless, end-to-end repair using epineural microsutures (neurorhaphy) provides the most favourable outcomes. Tensionless repair is acknowledged as a major factor in successful recovery of sensorimotor function. However, if a tensionless repair cannot be achieved, autologous nerve grafting is the gold standard treatment for surgical treatment of nerve gaps. However, autologous nerve grafting results in significant donor-site morbidity; is more technically difficult to perform; requires more operative time; and elevates treatment costs. The search for alternatives to nerve grafting has resulted in the development of nerve conduits, which are tubes fashioned of biocompatible materials. The proximal and distal ends of the severed nerve are inserted into the tube and sutured in place. The conduit provides gross alignment for the regenerating nerve, and retains fluids leaking from the nerve ends, enriching the microenvironment with neurotrophic growth factors. Conduits manufactured from bioabsorbable materials are preferred as non-degradable materials such as silicone require additional surgery for removal, and may have detrimental effects on nerve regeneration. Collagen is one of the most commonly used biomaterials for construction of nerve conduits. Key advantages of collagen are that it is biocompatible and has a natural structure that has been shown to support and guide tissue regeneration in vivo. Clinical studies have shown that digital nerve gaps of up to 40mm can be bridged with collagen conduits, resulting in good to excellent sensory outcomes in up to 75% of patients. CelGro"registered trademark" is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro"registeris mechanically stronger and more elastic than other collagen membrane products of this type. The main complication related to conduit implantation is protrusion or extrusion of the conduit. This is most common when the repair occurs across a joint or where the quality of covering soft tissue is reduced. However, in a systematic review of digital nerve repair using resorbable FDA- and CE-approved nerve conduits, protrusion or extrusion of collagen conduits was not observed

Interventions

Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold: CelGro "Registered Trademark is a next-generation porcine collagen membrane manufactured in Australia from locally-produced source material. It is classified as a Class III Medical Device and is intended for use in surgical applications such as tendon and soft tissue repair and guided tissue regeneration. This is an open label pilot study where adult patients who have a traumatic injury to one or mor

Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold: CelGro "Registered Trademark is a next-generation porcine collagen membrane manufactured in Australia from locally-produced source material. It is classified as a Class III Medical Device and is intended for use in surgical applications such as tendon and soft tissue repair and guided tissue regeneration. This is an open label pilot study where adult patients who have a traumatic injury to one or more of the peripheral nerves of the upper limb or hand that requires surgical repair will receive a single surgical implantation of CelGro "Registered Trademark at the site of the nerve end repair to be used as a conduit for nerve repair. The implantation will be performed by an Orthopaedic surgeon. The length of surgery time and recovery will depend on the number of nerves damaged and the size of the nerve gap. Haemostasis of the nerve ends will be achieved prior to placement of CelGro"Registered Trademark". Tensionless repair will be achieved using atraumatic sutures to secure the CelGro"Registered Trademark" scaffold to the epineurium of each nerve end, resulting in a tube of CelGro"Registered Trademark" connecting and encasing the nerve ends. The site of CelGro"Registered Trademark" attachment to each nerve end will be a distance approximately greater than or equal to the nerve diameter. Fibrin glue may be used to assist with adhesion. The size of the CelGro"Registered Trademark" scaffold used will depend on the size of the nerve gap. CelGro"Registered Trademark" is a classified as a medical device and is delivered in a sterile sealed pouch and presents as a white to off white sheet with a smooth and a slightly rough side and is intended for single use only.

Sponsors

Orthocell Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Male or female aged 18-50 years. Traumatic injury to one or more peripheral nerves of the upper limb or hand requiring surgical repair. Nerve gap <20mm. Able to require to the requirements of the protocol. Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP.

Exclusion criteria

Nerve gap >20mm Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders. Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy. Female participant who is pregnant or lactating. Known substance abuse. Participation in another study with an investigational product within the last 3 months of study treatment date. Concurrent medical condition which precludes the administration of the study treatment. Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026