One patient had their Cell Pouch removed after the donor islet cells were found to be contaminated with Candida albicans yeast.
Sernova’s Cell Pouch System has been well-tolerated, with 5 of 6 patients with Type 1 Diabetes (T1D) in cohort 1 achieving insulin independence at follow-ups for up to 3.5 years.
The updated data, from a phase 1/2 clinical trial (NCT03513939), were presented by primary investigator Piotr Witkowski, MD, PhD, Professor of Surgery and director, pancreatic and islet transplant program, University of Chicago, at the International Pancreas and Islet Transplant Association (IPITA), the International Xenotransplantation Association (IXA), and the Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress, held October 26 – 29 in San Diego, California.
“I am pleased with the overall patient outcomes and learnings from the first trial cohort. We have applied those learnings to the second patient cohort along with the introduction of the higher capacity 10-channel Cell Pouch,” Witkowski said in a statement. “I am encouraged by the positive safety profile observed with Cell Pouch implants longer than 4 years, and early patient outcomes with the enhanced 10-channel device that we are using in the second cohort. Enrollment of the second cohort is nearly complete, and I look forward to reporting further results.”
Cohort A utilizes an 8-channel version of the Cell Pouch while Cohort B utilizes a 10-channel version and also incorporates a revised and better-tolerated immunosuppression regimen. Cohort A has completed its enrollment of 6 patients, with follow-up ranging from 6 months to 3.5 years. Cohort B began enrolling in November 2022 and 6 of 7 planned patients have had the Cell Pouch implanted.
All 6 patients in Cohort A had successful implantations with no seromas, unexpected adverse events (AEs), or chronic pain or discomfort. Investigators observed surviving and functional islets in these patients as well as positive fasting and stimulated serum C-peptide in patients who maintained optimal immunosuppression. The first 5 patients achieved sustained insulin independence. All patients later received marginal dose supplemental islet infusions through the portal vein and all achieved HbA1c within the nondiabetic range (<6.5%) with persistent serum fasting and stimulated C-peptide levels.
Out of the 6 patients in Cohort B that have had the Cell Pouch implanted, 5 have completed 1 of 2 protocol-defined islet transplants to the Pouch. One patient had their Cell Pouch removed without complications after islets from the donor pancreas were found to be positive for the yeast Candida albicans. The patient recovered without any wound or systemic blood infection and remains insulin independent after an intraportal islet transplant. Other Cell Pouches were not contaminated.
The first evaluable patient in Cohort B has shown persistent fasting and stimulated serum C-peptide, with stable BETA-2 score up to day 180 after transplant. This patient’s HbA1c has also slightly improved from 7.5% at baseline to 6.9% at day 180. Patients in Cohort B have had no donor islet rejection or donor specific antibodies under the new immunosuppression regimen.
The study is primarily evaluating safety and tolerability of islet transplantation into Cell Pouch in patients with T1D, impaired hypoglycemia awareness, and a history of severe hypoglycemic episodes. It is also evaluating islet survival, reductions in severe hypoglycemic episodes, and reductions in HbA1c as secondary outcomes.
“We are very encouraged by the results and our learnings from our trial to date,” Cynthia Pussinen, chief executive officer, Sernova, added. “Having recently advanced the trial into Cohort B, using our higher capacity 10-channel Cell Pouch, we are already seeing positive signals for both safety and efficacy. We look forward to sharing the next trial update, in the coming months.”