Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr ! (Seite 805)
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Sernova Corp Presents Positive Preliminary Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes
(via TheNewswire)
Sernova's Cell Pouch (TM) with transplanted islet cells reached primary safety measurements and clinically significant efficacy outcomes including glucose-stimulated C-peptide and the release of insulin in the first patient transplanted
LONDON, ONTARIO - TheNewswire - July 3, 2019 - Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova's Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose-stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness.
Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator presented on Sernova's Cell Pouch technology and preliminary data from Sernova's current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation Association (IPITA) in Lyon, France.
Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova Cell Pouch included:
- No incidences of adverse events determined to be related to the Cell Pouch implant.
- The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets
- A weight reduction of 6.35kg (12% total body weight)
- Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose Monitoring (CGM) as assessed by Medtronic
- 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period
- Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point as indicated in a mixed meal tolerance test
"I am quite pleased with these interim results in the first implanted patient," said Dr. Witkowski. "The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy. Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-term results in enrolled patients as the trial progresses," said Dr. Witkowski, principal study investigator.
ABOUT IPITA
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant scientific community in providing a forum for the open exchange of knowledge and expertise in order to facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of human diabetes. ( https://www.tts.org/ipita/home)
ABOUT THE STUDY
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. 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.
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.
...
Quelle: www.stockwatch.com
(via TheNewswire)
Sernova's Cell Pouch (TM) with transplanted islet cells reached primary safety measurements and clinically significant efficacy outcomes including glucose-stimulated C-peptide and the release of insulin in the first patient transplanted
LONDON, ONTARIO - TheNewswire - July 3, 2019 - Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF), a clinical-stage regenerative medicine company today announced that in an interim analysis of its human Phase I/II clinical trial, Sernova's Cell Pouch transplanted with islet cells showed initial safety, as well as key efficacy measures, including glucose-stimulated C-peptide, insulin production and additional clinically significant measures of glucose control in the first study patient with type-1 diabetes and severe hypoglycemia unawareness.
Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator presented on Sernova's Cell Pouch technology and preliminary data from Sernova's current clinical trial: A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch for Clinical Islet Transplantation today at the 17th World Congress of the International Pancreas and Islet Transplantation Association (IPITA) in Lyon, France.
Highlights of the presentation of the data from the first patient who received islet transplanted into Sernova Cell Pouch included:
- No incidences of adverse events determined to be related to the Cell Pouch implant.
- The Cell Pouch was well-incorporated with vascularized tissue, which enabled successful transplant of the purified islets
- A weight reduction of 6.35kg (12% total body weight)
- Stabilizing improvements in all glycemic control parameters as indicated by Continuous Glucose Monitoring (CGM) as assessed by Medtronic
- 87.5% reduction in hypoglycemic events from baseline collected over a two-week monitoring period
- Presence of stimulated blood levels of C-peptide and insulin at the observed 90-day post-transplant point as indicated in a mixed meal tolerance test
"I am quite pleased with these interim results in the first implanted patient," said Dr. Witkowski. "The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy. Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch. These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-term results in enrolled patients as the trial progresses," said Dr. Witkowski, principal study investigator.
ABOUT IPITA
The International Pancreas and Islet Transplantation Association aims to serve the pancreas and islet transplant scientific community in providing a forum for the open exchange of knowledge and expertise in order to facilitate the advancement of the clinical practice of pancreas and islet transplantation for the treatment of human diabetes. ( https://www.tts.org/ipita/home)
ABOUT THE STUDY
The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, where diabetic subjects with hypoglycemia unawareness enroll into the study. Participants are then implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression, and a dose of purified islets, under strict release criteria, is transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects will be followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will then be further followed for one year. 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.
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.
...
Quelle: www.stockwatch.com
Antwort auf Beitrag Nr.: 60.906.759 von Ghost-Cash am 27.06.19 19:04:20Dr. Witkowski wird seine Ansprache während eines Symposiums zur Inseltransplantation am 3. Juli 2019 um 10:45 Uhr (MEZ) an der Katholischen Universität von Lyon im Amphitheater Merieux 1 & 2 halten. Weitere Informationen zum wissenschaftlichen Programm finden Sie unter die Konferenz-Website (http://www.ipita2019.org/programme-scientifique).
Antwort auf Beitrag Nr.: 60.906.054 von Wolfirainbow am 27.06.19 17:34:39Das Volumen ist noch zu tief. Aber nächste Woche könnte es sehr schnell gehen! Bin gespannt, ob auch die Wirkung in die Info einfliesst. Zumindest hat man den Fahrplan eingehalten.
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Antwort auf Beitrag Nr.: 60.904.677 von techinvestor69 am 27.06.19 15:17:39Der Hüpfer nach oben gestern und keine Gewinnmitnahmen heute muss ja einen kleinen Grund haben
gute News mit Ansage - Dienstag nehme ich an 
Sernova's Principal Investigator to Present Interim Data from the Company's Ongoing Phase I/II Cell Pouch Clinical Trial at the 17th World Congress of the International Pancreas and Islet Transplant Association
https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aSVA-2778…
Sernova's Principal Investigator to Present Interim Data from the Company's Ongoing Phase I/II Cell Pouch Clinical Trial at the 17th World Congress of the International Pancreas and Islet Transplant Association
https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aSVA-2778…
Antwort auf Beitrag Nr.: 60.694.520 von techinvestor69 am 29.05.19 21:49:20Gib Ihm mal Den Echelon INITIAL lieber, Meine Meinung.
Antwort auf Beitrag Nr.: 60.694.148 von Baatzii11 am 29.05.19 21:00:20
https://filehorst.de/d/ccItjhjx
Zitat von Baatzii11: Kann mir jemand bitte genaue Daten/Fakten über dieses Unrernehmen geben? Was genau ist hier möglich? Ein einfagher link würde auch reichen :-* danke
https://filehorst.de/d/ccItjhjx
Kann mir jemand bitte genaue Daten/Fakten über dieses Unrernehmen geben? Was genau ist hier möglich? Ein einfagher link würde auch reichen :-* danke
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