Patients With T1D Achieve Insulin Independence Following Implantation of Cell Pouch System and Islet Transplant

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Five patients in the cohort achieved this milestone and Sernova noted a sixth patient in the cohort is still awaiting assessment of islet graft function.

Five patients with type 1 diabetes (T1D) with severe hypoglycemia unawareness who were implanted with Sernova’s Cell Pouch System, an investigational medical device containing immune protected therapeutic cells, achieved insulinin dependence following islet transplant to the Cell Pouch and supplemental portal vein islet infusion.1

The 5 patients were among 6 patients being evaluated in the first cohort of a phase 1/2 clinical trial (NCT03513939) for the Cell Pouch System at the University of Chicago. Furthermore, Sernova noted that all 5 patients have sustained ongoing insulin independence for 6 months to 38 months, adding that the achievement of insulin independence was supported by a modest amount of islet top-up through the portal vein. The company also stated that surviving functional islets were observed on histological assessments performed on sentinel Cell Pouches that were excised 90 days or more following transplant. The sixth patient in the cohort is still awaiting assessment of islet graft function. 

The trial’s second cohort, which was cleared by the University of Chicago Institutional Review Board to begin enrolling patients in November 2022, has enrolled 5 patients so far; it is ultimately expected to enroll 7 patients in total.1,2 Unlike the first cohort, in which patients were implanted with an 8-channel Cell Pouch, patients in the second cohort are receiving implantation with a 10-channel Cell Pouch. The study’s protocol for the second cohort also calls for a reduction to 90-day intervals between islets transplants from the 180-day intervals used in the first cohort’s treatment.

All 5 patients enrolled in the second cohort to date have received implantation with the 10-channel Cell Pouch and 3 of these patients have received the first islet transplant to their Cell Pouch. Following 1 islet transplant, 1 of these 3 patients has shown persistent levels of serum C-peptide, which indicates islet insulin secretion. The patient has also exhibited persistent fasting and stimulated serum C-peptide levels. In terms of safety, Sernova stated that the implantation of the Cell Pouch System has been well-tolerated in both cohorts. The company noted that the first patient who received implantation in the second cohort necessitated stoppage of immunotherapy as a result of case of persistent neutropenia. Sernova anticipates reporting updated results from the trial’s second cohort before the end of the year.

“I continue to be encouraged by the results achieved in this trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell Pouch,” Piotr Witkowski, MD, PhD, the principal investigator of the trial and the director of the Pancreatic and Islet Transplant Program at The University of Chicago, said in a statement.1 “I look forward to reporting further data later this year.”

In addition to the clinical trial, Sernova is also conducting research on the potential use of the Cell Pouch System in conjunction with induced pluripotent stem cell (iPSC)-derived islet-like clusters (ILCs) as part of a collaboration with Evotec launched in May 2022.3 The program, also aimed at treating T1D, is currently in preclinical development. In April 2023, Sernova reported data from the preclinical research that included observed normalization of glycemic control in a mouse model of diabetes following implantation of ILCs into a Cell Pouch. Sernova plans to submit an investigational new drug application in 2024 for a phase 1/2 clinical trial that will evaluate the Cell Pouch in combination with iPSC ILCs.

“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” Philip Toleikis, the president and CEO of Sernova, added to the satement.1 “These additional data continue to confirm our understanding and provide verification of our estimates of islet dose thresholds and density required for optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived islet-like clusters in our upcoming clinical trial.”

REFERENCES
1. Sernova announces positive updated interim phase 1/2 clinical data for the Cell Pouch System at American Diabetes Association 83rd Scientific Sessions. News release. Sernova Corp. June 26, 2023. Accessed June 28, 2023. https://www.sernova.com/press/release/?id=374
2. Sernova receives authorization to enroll second patient cohort of phase 1/2 trial with Cell Pouch System for type 1 diabetes. News release. Sernova Corp. November 3, 2023. Accessed June 28, 2023. https://www.sernova.com/press/release/?id=350
3. Successful results using Sernova's Cell Pouch System with Evotec's IPSC-derived islet-like clusters for type 1 diabetes presented at the 4th IPITA / HSCI / JDRF summit. News release. Sernova Corp. April 24, 2023. Accessed June 28, 2023. https://www.sernova.com/press/release/?id=367
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