Comments on: Study of Islet Sheets in Diabetic Pigs: Difficult but Promising http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/ Islet Sheet and Diabetes Therapy Sun, 16 Jun 2013 21:48:58 +0000 hourly 1 http://wordpress.org/?v=3.5.1 By: katerina http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4243 katerina Tue, 18 Sep 2012 20:46:47 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4243 Can you explain more what do you mean with arun of good luck? Also estimation on a realistic (good) senario?
Thanks

]]> By: Scott King http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4241 Scott King Sun, 16 Sep 2012 13:30:48 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4241 Katerina, Brian’s question specified “best case”. Trials could start next year with a run of good luck. I can actually think of two places where it could happen. Possible but not likely.

]]> By: Scott King http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4240 Scott King Sun, 16 Sep 2012 13:28:08 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4240 Brett, I’m not sure. I think it depends on the host country. Medical tourism is a growing service is some countries like India, and they actively encourage patients to come to India. We want to get the therapy out to everyone who would benefit.

]]> By: katerina http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4239 katerina Sun, 16 Sep 2012 11:16:22 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4239 So if I understood correctly you are hoping to start human clinical trials in 2013?

]]> By: Brett http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4238 Brett Sun, 16 Sep 2012 03:07:27 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4238 Hi Scott, Thank you so much for the work you are doing. I was just wondering if and when the islet sheet is proven safe enough for other countries to approve, I know the USA and Canada will be the last, would a person be able to go over to another country and pay to have the procedure done? I was also wondering what the expected life of an islet sheet is before it needs replaced?? Thanks

]]> By: Gary http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4236 Gary Fri, 07 Sep 2012 20:48:39 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4236 I’m just saying we as citizens should be able to have the option to pursue the transplant shortly after it proves safe. Its not going to take anywhere near ten years to prove that. We will never know the long term effects until someone has it long term. If I were a young teen with my whole life ahead maybe it would be justifiable to wait but nearing 40 years of this with not a lot of time left on planet earth I feel I shouldn’t have to wait for FDA approval to pursue this. The only way to get around FDA approval is to be a recipient during the clinical trials. Scott, I take it your at least a couple years older then me but its your company and I ‘m sure you aren’t waiting around till the FDA decides its safe enough to commercialize. I don’t blame you. It’s your life and the FDA has no business dictating your life or anyone else’s that has diabetes.

]]> By: Scott King http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4235 Scott King Fri, 07 Sep 2012 17:06:34 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4235 Minor point Gary: the CIT-07 trial (islet allo-transplantation) has been submitted to FDA and will probably be approved in 2013. Thirteen years after Edmonton protocol publication.

My blog on this:
http://www.hanumanmedicalfoundation.org/blog/2012/06/11/islet-encapsulation-is-the-best-hope-as-islet-transplantation-declines/

]]> By: Gary http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4234 Gary Fri, 07 Sep 2012 11:31:15 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4234 Islet transplants that have been done for years now even with toxic drugs have not killed anyone to my knowledge. Most islet recipients that had the procedure done had some side effects from the drugs and it varied from person to person. Most said the side effects from the drugs were much more tolerable then dealing with roller coaster sugars. Of course this procedure was never FDA approved but they did approve the trials. Islet transplants themselves are relatively safe (I think?). The only change here is the fact the cells are protected. In my mind anyway this should be safer then toxic drugs that were used in the Edmonton protocol. The bottom line is there should be no reason the FDA needs to drag these trials out for a decade to insure safety. LCT is already years into this type of treatment and so far there are no reports of safety issues.I would bet that a good solid two to three years of proof of safety and effectiveness in humans and there would be enough diabetics to fill up every football stadium in the country and then some to have the transplant done.

]]> By: Brian Braxton http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4233 Brian Braxton Fri, 07 Sep 2012 01:11:58 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4233 I mention this before. What is the biggest risk with this type of “cure”. Potential allergic reaction to the sheets. Okay removal is an options if this happens. Worst case number 2, it does not work and a person will find this out quickly and they would need to go back on insulin. Not trying to make light of this or anything but from my perspective this would be worst case scenarios. This is why I know the FDA needs an overhaul, because they us a one size fits all approach to medical decision making. I believe the only exception maybe medical devices, which is what I feel this should come under. But hey I am a nobody :-)

]]> By: Scott King http://www.hanumanmedicalfoundation.org/blog/2012/09/05/study-of-islet-sheets-in-diabetic-pigs-difficult-but-promising/#comment-4232 Scott King Thu, 06 Sep 2012 21:25:08 +0000 http://www.hanumanmedicalfoundation.org/blog/?p=2313#comment-4232 Gary, we may do NHP (nonhuman primate) studies, we have not decided whether they are needed. It depends on how well pig and dog studies go. I agree that Islet Sheet therapy is safe, and should be permitted to go to clinical trials quickly, but it’s not my decision. There are many places outside the FDA’s control (Singapore for example) that are working to make a welcoming environment for biomedical research.

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