Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr ! (Seite 812)
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Antwort auf Beitrag Nr.: 59.749.410 von techinvestor69 am 30.01.19 20:16:47Ah ok! Das ist natürlich dann genau das Gegenteil von dem wie er es eigentlich meint. Danke, weiß ich jetzt Bescheid 😃
Antwort auf Beitrag Nr.: 59.749.410 von techinvestor69 am 30.01.19 20:16:47Ja so ist der ☺
Antwort auf Beitrag Nr.: 59.749.086 von Mammut22 am 30.01.19 19:49:46er verweist nur auf die Links, findet die News aber nicht schlecht
Antwort auf Beitrag Nr.: 59.745.915 von Popeye82 am 30.01.19 15:38:36.... und das ist schlecht weil? Oder hast du keinen anderen Finger gefunden?
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Sernova Announces Successful Enrollment Approaching 50% of Subjects in its U.S. Phase I/II Cell Pouch Diabetes Clinical Trial
January 17, 2019 9:00 a.m. EST
LONDON, ONTARIO – January 17, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova’s Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes.
“We are pleased to report we are on track with patient enrollment in the Sernova Cell Pouch study for type 1 diabetes,” stated Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “The Cell Pouch System is designed to improve the quality of life of people with diabetes and this milestone marks an important step towards building further validation of Sernova’s innovative approach to diabetes treatment.”
Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
About the Study
The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. Study subjects will receive Sernova’s Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch.
The sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second dose of purified islets. Patients will then be further followed to assess safety and efficacy for up to one year.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact (773) 702-2504.
About Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.
...
Quelle: https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aSVA-2707…
January 17, 2019 9:00 a.m. EST
LONDON, ONTARIO – January 17, 2019 – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF), a clinical-stage regenerative medicine company today announced the enrollment of the first three of seven subjects in its Phase I/II trial of Sernova’s Cell Pouch™ for Clinical Islet Transplantation in type 1 diabetes.
“We are pleased to report we are on track with patient enrollment in the Sernova Cell Pouch study for type 1 diabetes,” stated Dr. Piotr Witkowski, principal investigator and Director of the Pancreatic and Islet Transplant Program at University of Chicago School of Medicine. “The Cell Pouch System is designed to improve the quality of life of people with diabetes and this milestone marks an important step towards building further validation of Sernova’s innovative approach to diabetes treatment.”
Sernova is expecting to report preliminary safety data from this landmark clinical study in the first half of 2019 and preliminary efficacy data in the second half of 2019.
About the Study
The FDA allowed protocol is a Phase I/II non-randomized, open label, single arm, company-sponsored trial, where up to seven diabetic subjects with hypoglycemia unawareness enroll into the study under informed consent. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. The secondary objective is to assess efficacy through a series of defined measures including reduction in severe hypoglycemic events and HbA1c as well as survival of islets following transplant into the Cell Pouch. Study subjects will receive Sernova’s Cell Pouches including a small sentinel device implanted under the skin. Following a defined period to allow for the development of vascularized tissue chambers within the Cell Pouch, subjects will be stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, will be transplanted into the Cell Pouch.
The sentinel Cell Pouch will be removed after approximately 90 days to allow for an early assessment of islet survival in the device. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regard to the transplant of a second dose of purified islets. Patients will then be further followed to assess safety and efficacy for up to one year.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova or contact (773) 702-2504.
About Diabetes
Type 1 diabetes is a chronic disease that affects more than 42.5 million globally, in which the body's immune system attacks and destroys the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. To date, there is no cure for type 1 diabetes, and people living with the disease are dependent on insulin therapy, an imperfect treatment method that requires careful monitoring throughout the day along with multiple calculated doses of insulin to help regulate their blood sugar levels. A miscalculation or unexpected variable leading to high or low blood sugar episodes are daily threats, and only a third of people with type 1 diabetes achieve their long-term blood glucose targets, placing them at risk for type 1 diabetes-related health complications. Hypoglycemia unawareness, a subset of diabetes in which individuals experience a critical drop in blood sugar without warning symptoms, represents more than 15% of type 1 diabetes population.
About the Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.
...
Quelle: https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aSVA-2707…
Antwort auf Beitrag Nr.: 59.485.959 von Popeye82 am 21.12.18 01:14:28
www.sernova.com/press/#Press_Releases
www.uchicagomedicine.org/conditions-services/transplant/panc…
www.clinicaltrials.gov/ct2/show/NCT03513939
www.pwitkowski.org/sernova?utm_campaign=c8f39a3137-EMAIL_CAM…
www.sernova.com/press/#Press_Releases
www.uchicagomedicine.org/conditions-services/transplant/panc…
www.clinicaltrials.gov/ct2/show/NCT03513939
www.pwitkowski.org/sernova?utm_campaign=c8f39a3137-EMAIL_CAM…
Antwort auf Beitrag Nr.: 59.200.459 von Popeye82 am 12.11.18 21:44:44Und was soll ich dir sagen, selbst hier schreibst du am Thema vorbei
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