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CLINICAL STUDY |
1 Facultad de Medicina, Universidad Nacional Autónoma de México, and 2 Department of Surgery, 3 Department of Endocrinology, 4 Xenotransplant Laboratory of the Hospital Infantil de México ‘Federico Gómez’, México, D.F. Mexico, 5 Diabetes Research Institute, University of Miami, Miami, FL, USA, 6 Diatranz Ltd, Auckland, New Zealand and 7 Robarts Research Institute, University of Western Ontario, Ontario, Canada
(Correspondence should be addressed to Rafael A Valdés-González, Laboratorio de xenotrasplantes, 4° Piso Edif. Mundet, Hospital Infantil de México ‘Federico Gómez’, Calle Dr. Márquez 162, Col Doctores, C.P. 06720 México, D.F. Mexico; Email: rvaldes{at}xenomexico.org)
Objective: Porcine islets of Langerhans for xenotransplantation into humans have been proposed as a solution to the shortage of human donors. Rejection is one of the main constraints. This study presents the results of a clinical trial using a novel method for transplanting and immunoprotecting porcine islets in type 1 diabetic patients.
Design: A 4-year follow up of a clinical trial involving 12 patients, with no immunosuppressive drugs at any point. Eleven age matched untransplanted diabetics served as controls.
Methods: We have developed a procedure for protecting neonatal porcine islets by combining them with Sertoli cells and placing them in a novel subcutaneous autologous collagen-covered device.
Results: In the patients in the treatment group, no complications arose and no porcine endogenous retrovirus infection was detected. Half of the patients showed a significant reduction in insulin requirements compared with both their pre transplant levels and controls, and this reduction was maintained for up to 4 years. Two patients became insulin-independent for several months. Porcine insulin was detected in three patients’ sera following glucose stimulation up to 4 years post transplant. Three years post transplant, one of four devices was removed from four patients, and the presence of insulin-positive cells in the transplant was demonstrated by immunohistology in all 4 patients.
Conclusions: Long-term cell survival with concurrent positive effects on metabolic control are possible by this technique.
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M. Sykes and E. Cozzi Xenotransplantation of pig islets into Mexican children: Were the fundamental ethical requirements to proceed with such a study really met? Eur. J. Endocrinol., June 1, 2006; 154(6): 921 - 922. [Full Text] [PDF]
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R. Valdes-Gonzalez Reply to Sykes and Cozzi: 'Xenotransplantation of porcine neonatal islets of Langerhans and Sertolli cells' Eur. J. Endocrinol., June 1, 2006; 154(6): 923 - 923. [Full Text] [PDF]
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 E. Cozzi, E. Bosio, M. Seveso, M. Vadori, and E. Ancona Xenotransplantation--current status and future perspectives. Br. Med. Bull., January 1, 2006; 75-76: 99 - 114. [Abstract] [Full Text] [PDF]
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