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Also known as Processed Nerve Allograft (human)
Processed Nerve Allograft · 1 trial · 1 indication
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
| Arm | Type | Description |
|---|---|---|
| Processed Nerve Allograft | EXPERIMENTAL | Processed Nerve Allograft |
| Collagen Nerve Cuff | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Processed Nerve Allograft (human) | BIOLOGICAL | - |
| Collagen Nerve Cuff | DEVICE | Bovine collagen based nerve cuff |
Inclusion Criteria: * Peripheral Nerve Injury Exclusion Criteria: * Peripheral Neuropathy * Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Processed Nerve Allograft is a human nerve tissue product developed by Axogen, Inc. (ticker AXGN) for peripheral nerve discontinuities. It is used to bridge gaps in injured peripheral nerves. It is an investigational biologic in Phase 3 clinical development, evaluated in a single completed trial of 220 patients in the United States.
Processed Nerve Allograft is used for peripheral nerve discontinuities, meaning gaps in damaged peripheral nerves that require surgical repair. The Phase 3 trial compared it with collagen nerve cuffs for peripheral nerve repair in adults 18 years and older. It is being developed by Axogen, Inc. under ticker AXGN.
Processed Nerve Allograft is developed by Axogen, Inc., which trades under the ticker AXGN. Axogen is the sponsor of the clinical program evaluating the product for peripheral nerve discontinuities. The company conducted the Phase 3 trial comparing the allograft with collagen nerve cuffs for peripheral nerve repair.
Processed Nerve Allograft is in Phase 3 clinical development. Its single registered trial, NCT01809002, is completed, and no trials are currently active. The program has enrolled 220 patients total. It is an investigational product and is not described as FDA approved for peripheral nerve discontinuities.
Processed Nerve Allograft has been studied in one Phase 3 trial, NCT01809002, titled Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair. The trial was completed, enrolled 220 participants, was randomized, double blind, and active controlled, and was conducted in the United States in adults 18 years and older.
Yes. Processed Nerve Allograft is also known as Processed Nerve Allograft (human). Both names refer to the same Axogen, Inc. (AXGN) product being evaluated for peripheral nerve discontinuities. The alternative name reflects that the product is derived from human nerve tissue.