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.
In order to alleviate the shortage of human donors, the use of porcine islets of Langerhans for xenotransplantation in diabetic patients has been proposed as a solution. To overcome rejection, we have developed a procedure for protecting the islets by combining them with Sertoli cells and placing them in a novel subcutaneous device, that generates an autologous collagen covering. A type 1 diabetic woman was closely monitored for 10 months, and then transplanted in two devices with two months of difference and a third time after 22 months. Here we present a three-yr follow-up. The close monitoring induced a rapid decrease in exogenous insulin requirements, which stabilized between 19 and 28 IU/d for nine months. After transplantation, the requirements reduced further to below 6 IU/d and for some weeks she was insulin free. Glycosylated hemoglobin levels decreased concomitantly. Porcine insulin could be detected in the serum after a glucose challenge and insulin positive cells inside a removed device after two yr. No complications have arisen and no porcine endogenous retrovirus infection has been detected through PCR and RT-PCR. This case demonstrates the feasibility of using the xenotransplantation of porcine cells to alleviate metabolic complications and insulin requirements in type 1 diabetic patients.
Purpose: Determine the safety and efficacy of early enteral feeding after distal elective bowel anastomoses (DEBA) in children. Methods:Controlled randomized trial including pediatric patients with DEBA, excluding non-elective and high risk patients. Variables: Demographics, operative time, anastomosis placement, beginning peristalsis and bowel movement, time to full diet intake, post-operative stay, persisting vomiting and abdominal distention, wound infection or dehiscence, anastomotic leak, reoperation, death. Randomization into: 1)Experimental group (EG): early feeding group, after a minimum 24 hours fasting period, oral fluids and diet was started;2) Control group (CG): obligatory 5-day fasting. Descriptive Statistics:Student’s t test for quantitative and Chi square for qualitative variables, a p-value <0.05 was considered significant.Results: 60 patients were included since June 2003 to May 2004, 30 ineach group. Mean age 2 years, weight16 kg, malnutrition 33%. Stomal Ethiology: Anorectal-malformation 46%, Hirschsprung 13%, inflammatory 35%, tumoral 5%. Mostly in colon 71%. Mean surgical time 142 min. None developed vomiting or required nasogastric-tube. Mild abdominal distension 13%, mild fever 16.5% and wound complications 18%. Anastomosis leakage 6.5%, none required reoperations. Demographic variables showed no statistical differences. Full oral intake was in the 2nd postoperative day in the EG vs CG (p = 0.001). Postoperative hospital stay was 6.0±3 in the EG vs 9.8±4 days in the CG with clinical but not statistical significance. Peristalsis beginning, first flatus passage and bowel movements showed no statistical differences. The complication incidence was low and equally distributed. Conclusions: Early feeding after DEBA is safe and well tolerated in children.
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