April 24, 2013 – Dr. McAllister presented Cytograft's clinical progress at the American Heart Association's Emerging Science Series "Innovations in Vascular Bioengineering"
      • Webinar recording available HERE.
April 17, 2013 - Dr. L’Heureux presented a webinar for young professionals on "Developing an Industry Career in Biomedical Engineering". More information available via BMES.
April 10, 2013 – Society for Biomaterials 2013 Annual Meeting- Adam Young presented on work creating dermal fillers using Cytograft's TESA technology.
December 8, 2012 - Dr. L’Heureux was invited to Tianjin to speak at the International Symposium on Small Diameter Vascular Grafts.
April 23, 2012 – Dr. L’Heureux reports a new process with cell synthesized threads at the annual FASEB meeting.
      • Press release can be found HERE.
      • Scientific American story HERE.
      • MIT Technology Review HERE.
 
 

First Human use of an Allogeneic Tissue Engineered Vascular Graft: A first-in-human study to test the feasibility of an allogeneic tissue-engineered vascular graft

Presenter: Todd N. McAllister, Novato, Calif.

Moderators:
• Dr. Timothy J Gardner
• Dr. Elliott Antman: Chairman
• Dr. Robert Harrington

Panelists:
• Dr. Donna Arnett
• Dr. Eric R Bates
• Dr. Conville BrownFrank Sellke
 

Click HERE to view the slides presented.
Click HERE to view the webinar.

First Human Use of an Allogeneic Tissue Engineered Vascular Graft

Todd N. McAllister, Cytograft/St. Joseph’s Translational Res Inst, Novato, CA; Wojciech Wystrychowski, Medical UNiversity of Silesia, Katowice, Poland; Lech Cierpka, Krzysztof Zagalski, Medical Univ of Silesia, Katowice, Poland; Sergio A. Garrido, Fleni Hosp, Buenos Aires, Argentina; Samuel Radochonski, Nathalie Dusserre, Cytograft, Novato, CA; Nicolas L’Heureux, Cytograft/St. Joseph’s Translational Res Inst, Novato, CA

Introduction: End Stage Renal Disease (ESRD) is one of the most costly chronic diseases in the industrialized world. In the U.S., more than $27 billion is expended annually for the care of 400,000 dialysis patients. Creation and maintenance of access shunts is one of the principal challenges associated with dialysis, and accounts for 15% of all ESRD-related expenses. A more effective solution to hemodialysis access remains one of the key objectives in vascular surgery today. Previously we reported promising results with the first
human patients to receive a completely autologous tissue engineered vascular graft (TEVG) for hemodialysis access. With time points out to 3 years, we observed a 2.4-fold reduction in events relative to the pre-enrollment rates with the standard of care. The complexities of the autologous model, however, make it difficult to translate to widespread clinical use. We hypothesized that an allogeneic TEVG, available ‘off-the-shelf,’ would have similar benefits and may demonstrate improved efficacy and cost-effectiveness relative to synthetic grafts. Here we report the first human use of an allogeneic TEVG.

Methods:
TEVGs were built from allogeneic fibroblasts using a process termed Sheet-based Tissue Engineering. 30 cm long grafts with a diameter of 4.8 mm were built from cellular sheets without the inclusion of exogenous biomaterials. The lab-grown grafts were implanted as a shunt between the brachial artery and the axillary vein in three patients with ESRD. No HLA matching was performed. Results: With time points ranging from 1-7 months, all grafts are patent, with flow rates in excess of 600 ml/min. Doppler ultrasound exams show a normal pulse wave, and no changes in diameter or wall structure. Blood laboratory results are all within expected ranges, and lymphocytotoxic cross reactivity tests were uniformly negative. Conclusion: The allogeneic TEVGs do not initiate short-term immune reactions, and appear to tolerate both the hemodynamic loads and the needle punctures associated with hemodialysis access. This short-term result, coupled with the dramatic reduction in event rate for the autologous studies, suggests that an off-the-shelf TEVG with improved efficacy relative to the standard of care may finally be within reach.