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Sernova’s Cell Pouch System shows sustained clinical benefit in study patients with type 1 diabetes through multiple efficacy indicators and ongoing safety and tolerability
- 5 of 7 patients are currently enrolled in the study.
- 5 of 7 patients have been implanted with the Cell Pouch
- 3 of 7 patients have received their first/one islet transplant
- 2 of 7 patients have received their first and second islet transplant
- The remaining 2 patients are actively being pre-screened to complete trial enrolment
The overall objective of the study is to assess the safety, tolerability, and efficacy of the Cell Pouch with insulin-producing islets. In addition to other criteria, prior to entry into the study, the patients must demonstrate long-standing type 1 diabetes with severe hypoglycemic unawareness episodes and no glucose-stimulated C-peptide circulating in their bloodstream.
In his presentation, aside from confirming ongoing safety and tolerability in all currently enrolled patients,
- Absence of life threatening severe hypoglycemic events;
- Sustained blood levels of C-peptide (a biomarker for insulin produced by cells in the Cell Pouch);
- Reduction in HbA1c (a measure of long-term glucose control); and,
- Improvement in overall Continuous Glucose Monitoring (CGM) measured glucose control parameters (e.g., blood glucose ‘Time in Range’).
With the positive clinical benefit achieved in patients with Cell Pouch islets, one patient was later provided a single infusion of islets (portal vein). This top-up to the islets already received in the Cell Pouch contributed to this patient achieving and sustaining insulin independence. This patient has now been insulin free (requiring no injectable insulin) for nine months with optimal glucose control.
“I am pleased with the invitation to present additional positive preliminary clinical trial results to my esteemed peers at the 2021 ASTS meeting,” said
ABOUT SERNOVA’S CLINICAL TRIAL
Eligible subjects are implanted with Cell Pouches. Following 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, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are 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. Following this period, eligible patients may be administered a single dose of islets through the portal vein. Patients will be then further followed for one year to assess longer-term safety and efficacy.
This study is supported in part by funding from JDRF, the leading global organization funding type 1 diabetes (T1D) research.
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.
ABOUT
For further information contact:
Tel: (519) 858-5126
dominic.gray@sernova.com
www.sernova.com
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although
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Copyright (c) 2021 TheNewswire - All rights reserved., source