Cytograft currently has approvals for two clinical trials; one in Buenos
Aires, Argentina (A-V shunt for dialysis patients) and one in Cambridge,
United Kingdom (coronary bypass patients). Both centers are actively
enrolling patients.
Cytograft anticipates U.S. based clinical trials for lower limb
revascularization and A-V shunts in mid to late 2006. Updates will be posted on
this website and will also be available on www.clinicaltrials.gov
Preclinical Research
Cytograft’s pre-clinical research over the last 5 years has demonstrated that the Lifeline™ graft is anti-thrombogenic and has appropriate biomechanical properties that justify use in human trials. Cytograft’s first clinical trial focuses on use of the Lifeline™ graft as an A-V shunt for hemodialysis patients that would otherwise receive a synthetic ePTFE shunt. ePTFE shunts have historically shown very poor patency rates, prompting the National Kidney Foundation to promote an initiative to decrease the use of synthetic grafts (Dialysis Outcome Quality Initiative). The Lifeline™ graft addresses the primary failure modes associated with synthetics and may be a clinically viable alternative to ePTFE and other non-native tissues.
In preparation for an IND application to the FDA, Cytograft has performed several studies specific to the A-V access indication.
Puncture of Lifeline™ Graft compared to Synthetic Graft
In vitro tests show that after puncture, the Lifeline™ graft seals well even without the benefit of a maturation period in vivo and subsequent tissue integration. ePTFE grafts, by contrast, leak profusely after puncture. Both vessels are pressurized to 100mmHg.
Here, the Lifeline™ graft is shown being sewn in as a shunt between the femoral artery and the femoral vein. Lifeline™ tolerates the increased hemodynamic loads associated with accelerated A-V blood flow.
After only a few days of maturation (the standard of care is several weeks), the Lifeline™ graft tolerates puncture with no evidence of mechanical failure and rapid hemostasis times. Click below to see the Lifeline™ graft being punctured under ultrasound guidance.
a new paradigm in revascularization
