Accession Number:

AD1047611

Title:

Instructive Biologic Scaffold for Functional Tissue Regeneration Following Trauma to the Extremities

Descriptive Note:

Technical Report,30 Sep 2012,31 Aug 2017

Corporate Author:

The Geneva Foundation Tacoma United States

Personal Author(s):

Report Date:

2016-10-01

Pagination or Media Count:

10.0

Abstract:

Our hypothesis is that subjects who receive the SIS-ECM scaffold material will have significant new muscle growth and improvements in strength in the treated extremity. The proposed prospective, non-randomized, two-armed study in forty 40 subjects will establish the safety and effectiveness of a regenerative scaffold for the restoration of functional musculotendinous tissue, including the restoration of blood supply and innervation. Cohort 1 will include 20 subjects with upper extremity flexor and extensor traumatic, postoperative, or other avulsive VML. Cohort 2 will include 20 subjects with open femur fractures or soft tissue injury to the thigh resulting in VML. The primary endpoint will be changes in graft site muscle volume compared to baseline at 6 and 12 months as determined by imaging.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE