Fibralign Corporation — Department of Defense SBIR Phase I: Lymphedema, accumulation of lymph fluid in the tissue, is a disabling condition most commo

Description

Lymphedema, accumulation of lymph fluid in the tissue, is a disabling condition most commonly caused by removal of lymphatic nodes during cancer surgery. There is no cure for lymphedema, and all available remedies are palliative and reduce fluid accumulation by massage and compressive garments. To address the lack of treatment for lymphedema patients we propose to guide lymphatic regeneration by the cell-seeded graft. The graft consists of multi-lumen thread made from aligned Nanoweave collagen fibrils by Fibralign patented process, seeded with human lymphatic endothelial cells (LECs). These collagen fibrils closely resemble the native structure of the inside wall of the lymphatic vessel, and provide for cell attachment and alignment. The collagen thread facilitates site-specific cell delivery, enhances the survival of implanted cells. Ultimately, the goal of the LEC-seeded graft is to bridge the gap in the lymphatics caused by surgery. Primary LECs have aligned on the collagen fibrils, and LECs seeded on the thread have demonstrated excellent survival rate after subcutaneous implantation in mice. We propose to standardize the physical properties of the collagen threads by crosslinking and to implant these constructs with and without LEC in mice to test whether the LEC will integrate into the existing lymphatics.