BIOELASTIC MATERIAL TO PREVENT POST-LAMINECTOMY ADHESION
Project Number5R44HD034999-03
Contact PI/Project LeaderXU, JIE
Awardee OrganizationBIOELASTICS RESEARCH, LTD
Description
Abstract Text
Using two biocompatible elastic protein-based polymers (in viscolelastic gel and elastic sheet forms), the Phase I study demonstrated both materials to be highly effective in preventing adhesions to the spinal dura in the rabbit laminectomy model. The specific aims of Phase II are: 1) to identify the preferred membrane and/or gel configuration(s) of two biocompatible and resorbable polymer compositions for prevention of adhesions in a large animal laminectomy model, 2) to develop sensitive double radio-label standards for purification and a quality control protocol, 3) to utilize an adult sheep lumbar spine model with laminectomies performed at two non-contiguous levels (L3-L4 and L5-L6) allowing for a randomization of the polymer placement to surgical site, 4) to develop a mechanical test method for assessing the interface between the dura mater and the tested polymer and the epidural fibrotic tissue at the control site, and 5) to complete biocompatibility testing and prepare an IDE application for the preferred polymer(s) and state(s). The physical disability resulting from intervertebral disc herniation constitutes the third most common condition for worker disability in the U.S. An improved outcome of intervertebral disc laminectomy would improve the quality of life and restore function for many millions of disabled Americans. PROPOSED COMMERCIAL APPLICATION: Low back pain, for which intervertebral disc pathology is the major cause, is second only to the common cold for work absenteeism in the United States; it is reported to result in more productivity loss than any other medical condition and in an annual health care cost of $33 billion. Over four million cases of prolapsed intervertebral discs are reported annually in the U.S. Development of materials that would improve the outcome of intervertebral disc laminectomy would clearly be of commercial significance while impacting favorably on medical care costs.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
adhesionsbioengineering /biomedical engineeringbiomaterial compatibilitybiomaterial development /preparationbiomaterial evaluationbiotherapeutic agentelasticitygelhistologylaminectomypeptide structurepolymerspostoperative complicationsprotein purificationsheepspinal disk injury
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
929
DUNS Number
UEI
Project Start Date
01-March-1997
Project End Date
30-June-2003
Budget Start Date
01-July-2001
Budget End Date
30-June-2003
Project Funding Information for 2001
Total Funding
$376,921
Direct Costs
$249,587
Indirect Costs
$121,316
Year
Funding IC
FY Total Cost by IC
2001
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$376,921
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 5R44HD034999-03
Publications
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No Outcomes available for 5R44HD034999-03
Clinical Studies
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