ECEESPE2025 Oral Communications Oral Communications 8: Diabetes and Insulin Part 2 (6 abstracts)
The Proof of Concept INCEPTR trial 12 month outcomes – Intracutaneous islet transplant in humans into pre-vascularised Novosorb® neodermis
Patrick Coates 1,2 , Daniella Penko 1 , Jodie Nitschke 1 , Julie Johnson 1 , Svjetlana Kireta 1 , Elizabeth Concannon 1 , Tom Loudovaris 3 , Alice Rickard 1 , Colleen Etherton 1 , Patrick Coghlan 1 , David Torpy 1 , Thomas Kay 3 , Shane Grey 4 , John Greenwood 1 & Chris Drogemuller 1
1Royal Adelaide Hospital, Central Northern Adelaide Renal and Transplantation Service, Adelaide, Australia; 2Royal Adelaide Hospital, Adelaide, Australia; 3St Vincent’s Institute of Medical Research, Diabetes and Immunology Unit, Melbourne, Australia; 4University of New South Wales Sydney, Department of Biomedicine and Biotechnology, Sydney, Australia
JOINT320
Introduction: Allogeneic islet-cell-transplantation (ICT) is an established treatment for hypoglycaemic unawareness for selected people living with Type-1 diabetes (T1D) available in Europe, the UK and Australia. As ICT is currently practiced, allogeneic human islets are transplanted into the liver via the portal vein. However, up to 75% of the transplanted islet mass is lost within the first 48 hours post-transplant, due to the Instant Blood Mediated Inflammatory Reaction. Furthermore, the hepatic transplant site is unable to be easily biopsied, transplanted islets are unable to be monitored or retrieved, limiting the ability to detect and treat islet graft rejection. In order to develop an alternative to intra-hepatic ICT we pre-implanted a Biodegradable Temporizing Matrix (Novosorb®) into the inner-bicep of three trial participants prior to ICT as part of our INtra-Cutaneous Ectopic Pancreas TRial – INCEPTR. Pre-implantation of Novosorb® created a fully functional dense vascular bed capable of supporting transplanted islets within the intracutaneous-transplant site (Diabetes 2023 PMID: 36929171). Unlike the hepatic site, intracutaneous islet grafts can be monitored in vivo, enable topical immunosuppression and removed in toto, thus creating an attractive site for gene modified, xenogeneic- and stem-cell-derived ICT.
Method: INCEPTR is a prospective first-in-human study of allogeneic ICT into a pre-vascularised intracutaneous transplant site : Australian and New Zealand Clinical Trials Registry (ACTRN12621001573842). The INCEPTR trial primary outcome was detectable c-peptide at 3 months post-transplant. Secondary outcomes included average daily exogenous insulin usage and HbA1c measured at baseline, 3, 6 and 12 months post-transplant.
Results: Three immunosuppressed kidney transplant patients with longstanding T1D (c-peptide negative) underwent Novosorb® implantation under local anaesthesia as outpatients prior to intracutaneous cadaveric human islet transplantation.
| Pt | Pre-Islet transplant Novosorb® integration period | Total IEQ transplant | 3/12 c-pep | 3/12 HbA1c reduction | 3/12 insulin reduction | 6/12 HbA1c reduction | 6/12 insulin reduction | 12/12 HbA1c reduction | 12/12 Insulin reduction |
| 1 | 25 days | 485,584 | pos | 1.1% | 21% | 1.8% | 22% | 1.8% | 28% |
| 2 | 33 days | 204,633 | neg | 1.1% | 10% | 0.6% | 7% | 0.8% | 21% |
| 3 | 76 days | 276,026 | pos | 0.3% | 44% | 0.3% | 44% | 1.3% | 62% |
Conclusions: In this study two of three participants had positive c-peptide at 3 months with all patients showing improvement in glycaemic control over 12 months. One of the patients with positive c-peptide at 3 months has ongoing long-term detectable graft function out to 2.5 years post engraftment. The prevascularised Novosorb® neo-dermis is safe and supported human islet cell survival in an intracutaneous transplant site outside of the liver.
Volume 110
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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