Pressure ulcers are a major health problem affecting millions of adults in the USA. They can be a significant site for infection leading to complication such as septicaemia and osteomyelitis, in addition to causing significant pain and suffering, compromised quality of life, financial burden, and morbidity/mortality. In conjunction with an aging population, particularly those with diabetes, kidney disease, and heart disease, the occurrence of pressure ulcers will most likely continue to rise. There is a recognized clinical need for improved treatment of pressure ulcers, particularly those with undermining and tunneling voids. In this research an injectable matrix to safely deliver autologous cells or cellulr products into soft tissue defects or void spaces is proposed, especially for treatment of tunneling and undermining Stage III/IV pressure ulcers. At the present time there are no clinically useful products that can protect transplanted cells while concurrently filling voids in tunneling/undermining wounds and promoting wound healing. A critical barrier to progress in the field is that cell injection without an appropriate scaffold leads to the cells leaving the point o injection rapidly with cells exhibiting diminished viability due to the injection process. The desin of the product facilitates incorporation into clinical practice and should enhance clinical strategies for filling wound voids and treating tunneling and undermining found in Stage III/IV pressure ulcers, which is an unmet need. The overall goal of this proposal is to commercialize an injectable system that can be used alone or in conjunction with cells to fill and treat soft tissue voids such as tunneling or undermining wounds, commonly seen in pressure ulcers. The first specific aim is manufacture, process, and sterilize the product under GMP conditions.
The second aim will characterize preclinical safety of the material. In vitro cytotoxicity and mutagenicity will be determined as well as in vivo safety studies. The third specific aim will determine preclinical efficacy of the product. A rat pressure ulcer model and porcine excisional wound model, as well as a porcine tunneling wound model, will be used to determine angiogenic and wound healing potential of the product. The fourth specific aim will initiate product stability and shelf-life testing. Quality control specifications for manufacturing will be developed in addition to preliminary data collection for shelf-life testing. An injectable biomateral system which has been designed for facile delivery of cells to soft tissue defects has been developed under NIH SBIR Phase I work and is to be taken through GMP manufacturing and preclinical trials under this Phase II project to facilitate FDA submission and Phase III commercialization.

Public Health Relevance

There is an increasingly critical clinical need for an injectable matrix to safely deliver autologous cells or cellular products into soft tissue defects or void spaces, especially for treatment of Stage III/IV pressure ulcers with tunneling and undermining (estimated U.S. treatment cost of $13 billion dollars in 2014). Currently there are no clinically useful products that can protect transplanted cells while concurrently filling voids in tunneling/undermining wounds and promoting wound healing. An injectable biomaterial system which has been designed for facile delivery of cells to soft tissue defects has been developed and will be taken through GMP manufacturing and preclinical trials for FDA submission.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44GM108070-02
Application #
8777076
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cole, Alison E
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Rochal Industries, Llp
Department
Type
DUNS #
City
San Antonio
State
TX
Country
United States
Zip Code
78230