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IRW-PRESS: Sernova Corp. : Sernova Launches Patient Selection and Recruitment for US Diabetes Clinical Study
Sernova Launches Patient Selection and Recruitment for US Diabetes Clinical Study
LONDON, ONTARIO , July 5, 2018 – Sernova Corp. (Sernova or the Company) (TSX-V: SVA) (OTCQB: SEOVF) (FWB: PSH) announces that screening tests and recruitment of patients with diabetes as well as hypoglycemic perceptual disorders for a regenerative clinical trial [19659002] The initial clinical evaluation of Sernova's pre-vascularized tissue pocket – Cell Pouch (TM) – had demonstrated its biocompatibility and safety as well as the viability and vascularity of its insulin-dependent islet cells. transplanted, which have been demonstrated in a pre-vascularized study. implantable medical device.
This first human trial provided the framework for the development of the new clinical protocol for the Sernova Phase I / II trial. Our clinical team here at the University of Chicago can not wait to start the study on Sernova's transformation technology, said the research director, dr. Piotr Witkowski, MD, Ph.D.
Sernova and CTI (Clinical Trial and Consulting), a leading clinical research company with extensive experience in the field of regenerative medicine, work closely together to deliver test deliveries. clinics with the highest standards of quality. with the dr team. Witkowski work together, Dr. Philip Toleikis, President and CEO of Sernova
This is a non-randomized, open, branch-sponsored, phase I / II clinical trial sponsored by a society. Under the clinical direction of Dr. Ing. Witkowski, University of Chicago Medicine, implants the cell pocket on study participants with hypoglycemic cognitive impairment with their informed consent. Following the vascularized tissue development in the cell pocket, a first dose of purified islet cells is transplanted into the cell pocket according to strict criteria for drug delivery.
A synchronized pocket (sentinel pocket) implanted simultaneously with islets, which also includes islets. removed for early evaluation of islet cell transplantation. Follow-up will track the safety and effectiveness of treatment for the 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 intermediate outcomes of participants periodically published as part of an open study.
About Sernova's Cell Pouch Technology
to provide a novel, protected, scalable, implantable, pre-vascularized macroencapsulation device for the long-term survival and functioning of therapeutic cells (donor cells, cells strains and xenogeneic cells). 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 joining tissue and forming highly vascularized tissue chambers for transplantation and therapeutic cell function. 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.
However, currently available insulin therapy is inadequate as it requires strict control of the daily glucose levels of T1D patients, and the administration of multiple doses of insulin needs to be tailored precisely to consumption, to exercise and exercise, stress, illness and other factors. ,
Patients are daily faced with the threat of hyperglycemic or 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. As a result, they are at increased risk of TID-related complications.
About Sernova Corp.
Sernova is interested in the development of regenerative medical technologies involving the treatment and quality of life of people using an implantable medical device and immunoprotective therapeutic cells. Chronic metabolic diseases such as insulin-dependent diabetes, blood disorders such as hemophilia, as well as other diseases that can be treated by replacing the missing proteins or hormones in the body, can be improved. For more information, visit www.sernova.com
For more information, contact:
Philip Toleikis, Ph.D., President and Chief Executive Officer
Tel .: (604) 961-2939
Philip. [19649023] Ray Matthews & Associates
Tel. Forward-Looking Information
This press release may contain forward-looking statements. Forward-looking statements are statements that are not based on historical facts and that generally, but not always, are expressed in terms of anticipation, planning, anticipation, belief, esteem , prediction, potential and similar expressions or expression. Events or circumstances could, could, should, or should occur. Although Sernova believes that the expectations expressed in such forward-looking statements are based on realistic badumptions, these statements are not indicative of future performance. Actual results may differ materially from those in the forward-looking statements. Forward-looking statements are based on the badumptions, estimates and beliefs of Sernova's management as of the date such statements are made. This includes our belief in the implementation and success of clinical trials and that Sernova will be able to provide additional capital to fund its clinical programs – such as its planned and approved clinical trial 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 future events or otherwise.
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