SBIR-STTR Award

Novel Super-cooling of Genitourinary Cells and Tissues for Transplant
Award last edited on: 10/13/2020

Sponsored Program
SBIR
Awarding Agency
DOD : DHA
Total Award Amount
$1,153,602
Award Phase
2
Solicitation Topic Code
DHP16-012
Principal Investigator
Xiaoxi Wei

Company Information

X-Therma Inc

2600 Hilltop Drive Suite B220
Richmond, CA 94806
   (716) 861-150
   info@x-therma.com
   www.x-therma.com
Location: Single
Congr. District: 13
County: Alameda

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2016
Phase I Amount
$154,635
GU injuries have been amplified as dismounted patrols have increased and frequent exposure to improvised explosive devices (IEDs) in recent conflicts. Penile injury incurred on the battle field increases the complication of performing replantation surgery. Generally, more time is required beyond the available 6 hours of biological time after dissection for autogenous reconstruction. Promisingly, hypothermia has been shown to extend the tissue survival by decreasing ischemic effect. X-Therma is developing bioinspired, non-toxic and hyper-effective ice-prevention solutions via biomimetic nanoscience. We propose novel protocol and advanced CPA formulation for preservation of the penis and penile tissues at sub-zero temperature (-20C for 1 week storage, -80C for 1 month storage) from near battle field settings. The goal is to create On Demand Organs/Tissues and offer adequate tissue preservation times to perform further tissue repair and replantation or assist transplantation of a donor organ. The novel CPA formula will be developed based on low toxicity, hyper effective anti-ice nanomaterials developed via biomimetic nanotechnology that can dramatically reduce the concentration of cytotoxic CPAs required. Mathematical modeling will be performed to assess the many complicated interactions between toxicity, exposure time, and mechanical stresses and inform protocol development.

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
2017
Phase II Amount
$998,967
A key bottleneck to be addressed in regenerative medicine is hypothermic preservation of cells and tissues, which has been shown to extend survival of cell and tissue-based therapies by decreasing ischemic effect. However, preservation technology is aged, toxic and less effective than desired with typical cell survival post-thaw below 50% and unreliable potency. Current technology greatly hinders efforts to repair traumatic injury and chronic disease using new cell and tissue-based therapies. This proposed technology supports the critical preservation infrastructure needed to enable post-delivery assurance of therapy viability, function, and efficacy. The super-cooled storage formula and protocol developed during Phase I using commonly available freezers (-20C) will be broadly applied to preserve genitourinary cell types and then focused for the preservation of penile tissue at sub-zero temperatures (-20C for 1 week storage, -80C for 1 month storage). Tissue preservation and corresponding tissue transplants will be studied in collaboration using a murine model system developed at an esteemed USA medical school. The novel preservation formulas are made possible by negligibly toxic, hyper-effective anti-ice nanomaterials developed via biomimetic nanotechnology that can dramatically reduce the concentration of cytotoxic CPAs required to prevent tissue damaging ice formation by 50-90%, depending on temperature regime.