Development of a Novel Cryostasis Cocktail and Protocol for High Subzero Banking of Human Organ (Phase 2, for H151-013-0141)

Period of Performance: 09/29/2016 - 02/28/2019

$1MM

Phase 2 SBIR

Recipient Firm

SYLVATICA BIOTECH INC
NORTH CHARLESTON, SC 29406
Firm POC
Principal Investigator

Abstract

This program targets the banking of human organs and tissues for urgent trauma and transplantation medicine as well as for regenerative medicine and tissue manufacturing more broadly. We propose a nature-inspired, holistic and non-toxic solution to dramatically extend preservation times by employing the best strategies used by freeze-tolerant and hibernating animals in Nature augmented with complementary bioengineering and biopreservation principles. Importantly, we dont seek to solve all the problems needed for vitrification or classical cryopreservation, but rather be first to develop organ preservation in a controlled, partially frozen equilibrium state using high subzero temperatures ( -5 to -30 C) - combined with metabolic depression and stress tolerance. An integrated approach is conceived to develop new stasis cocktails optimized for the critical phases of protection (prior to storage), preservation (during storage) and revival-resuscitation (after storage). The storage capability at -20C established in Phase I for hepatocytes will be extended in Phase II through 3 principal efforts: (i) further optimization of the prototype cryostasis cocktail and protocol optimization, (ii) scale-up via our proven whole rat liver models, (iii) initial scaling to preserve human livers and assessment using the Harvard/MGH liver perfusion platform and, as a stretch goal, full human liver pseudo transplants.