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Sernova launches selection of patients and R recruitment for his clinical study on diabetes in the United States
LONDON, ONTARIO, on 5. July 2018 – Sernova Corp. (" Sernova " or the "Company") (TSX-V: SVA) (OTCQB: SEOVF) (F WB : PSH) announces that the examinations screening and recruitment of patients with diabetes as well as hypoglycemic perceptual disorders for a clinical study in the field of regenerative medicine in the United States ha ben .
Initial clinical evaluation of Sernova of tissue bag pre-vascularized – Cell Pouch (TM ) – demonstrated its biocompatibility and safety as well as the viability and vascularization of its transplanted islet cells . insulin, which were here for the first time pravasculated implantable medical device was successful.
"This first human trial provided the framework for II working from the new phase I / II clinical trial of Sernova . clinical team here at the University of Chicago can not wait to start the study on Sernova's transformation technology Piotr Witkowski MD, [19659010] Ph.D. .
" Sernova and CTI (Clinical Trial and Consulting), a renowned clinical research company with fundier [19659017] must support the timely conduct of the clinical trial according to the highest quality standards. Experience in the field of medicine egenerative, working closely with the dr. Witkowski working together, "Dr. Philip Toleikis President and CEO of Sernova .
This is about 39, a non-randomized, open-arm, single-arm, phase I / II study sponsored by a company under the clinical direction of Dr. Ing. Witkowski University of Chicago Medicine becomes study participants with perceptual disorders hypoglycemic with their consent declared on Cell Pouch implanted According to a vascularized vascularized development in the pocket Cell becomes a first dose of islet cells purified according to strict criteria ] n for the administration of m Medications in cell Pouch transplanted.
A "surveillance pocket" (Sentinel Pouch ) implanted simultaneously with islet cells in which islet cells were also inserted is removed for early badessment of islet transplantation. Follow-up (follow-up) will track safety and effectiveness of treatment for subjects for six months. At this time, the transplantation of a second dose of islet cells will be followed by another follow-up to demonstrate safety and effectiveness.
Patients are then followed for one year with the provisional results of participants being published at regular intervals as part of an open study
.
About developed by Sernova Cellular Cover Technology
Pile Cover is a new macroencapsulation device pre-vascularized proprietary, scalable, implantable, for the survival and long-term functioning of therapeutic cells [cellulesssuccesschelicinesandxenogeneiccells). These cells then release the proteins and / or hormones needed to treat the disease.
The device was developed to address the concerns of fibrosis during implantation by badociating with tissue and highly vascularized tissues for transplantation and the therapeutic function Shapes of cells. In small and large scale animal models of diabetes, the safety and long-term effectiveness of the therapeutic cell delivery device could be confirmed.
It has also been shown that the device creates a biocompatible environment for insulin-producing cells in humans.
About Diabetes
Type 1 Diabetes (T1D) is a life-threatening disease. In doing so, the body's immune system attacks and falsely kills the pancreatic cells that produce insulin. Insulin is an essential hormone that helps the body to metabolize glucose.
The current standard of care for T1D patients is suboptimal. T1D is still not curable and people who must live with this condition are dependent on exogenous insulin therapy. This therapy ensures the absence of excessive blood sugar which, in the long run, can lead to complications such as kidney and heart disease or an acute and life-threatening health crisis.
The insulin therapy available today is inadequate as a mode of treatment as it requires strict control of T1D1 patients' blood glucose levels throughout the day and the administration of multiple doses of D1. Insulin for diet, exercise and exercise, stress, illness and other factors must be accepted.
Patients are daily confronted with the threat of hyperglycemic episodes and hypoglycemic episodes due to miscalculations or unexpected variables. Only a third of patients with T1D successfully adjust their blood glucose levels in the long term. They present an increased risk of complications related to IDD.
About Sernova Corp.
Sernova is involved in the development of regenerative medical technologies using an implantable medical device and immunoprotective cells to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes mellitus, hemopathies and other diseases. Replacement of missing proteins or hormones in the body can be treated, can be improved. For more information, see www.sernova.com .
For more information, please contact:
Philip Toleikis Ph.D., President & CEO
Tel .: (604) 961- 2939 [19659171] [email protected]
www.sernova.com
Ray Matthews and Associates
Telephone: (604) 818-7778
www. raymatthews.ca
Forward-Looking Information
This press release may contain forward-looking statements . Forward-looking statements are statements that are not based on historical facts and generally, but not always, in such terms as "forecast", "plan", "anticipate", "believe", "estimate", " anticipate "" expressing potential or "similar expressions" or expressing that events or circumstances "will", "may" or "should". Although Sernova submits that the forward-looking statements are based on realistic badumptions, such statements are not indicative of future performance. Actual results may differ materially from those of the forward-looking statements . The forward-looking statements are based on badumptions, estimates and opinions of the management of [Sernova at the time of the statements. These include our belief in the implementation and success of clinical trials and that Sernova will be able to provide additional capital to finance his clinical programs – such as his clinical trial and [19659010] approved in the United States. Sernova has neither the intention nor the obligation to correct or update forward-looking statements whether as a result of new information or information Future events or otherwise.
The source language (usually English) in which the original text is published is the official, authorized and legal version. This translation is provided for a better understanding. The German version can be shortened or summarized. No responsibility or liability is accepted for the content, accuracy, adequacy or accuracy of this translation. From the translator's point of view, the message is not a recommendation to buy or sell! Please see the original message in English on www.sedar.com www.sec.gov www.asx.com .au / or on the company's website!
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