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Islet Cell Transplant
Islet Cell Transplant is a Small molecule drug developed by University of Illinois at Chicago. It is currently in Phase 3 development for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes. Also known as: Allogeneic islets.
Islet cell transplantation restores insulin-producing beta cells to the pancreas, enabling endogenous insulin secretion and glycemic control in patients with type 1 diabetes.
Islet cell transplantation is a treatment studied for conditions such as Type 1 Diabetes Mellitus, where isolated cadaveric islet cells or labeled islets are transplanted into the liver. The mechanism of islet cell transplantation is currently unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Islet Cell Transplant |
|---|---|
| Also known as | Allogeneic islets |
| Sponsor | University of Illinois at Chicago |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
This procedure involves isolation and transplantation of pancreatic islet cells (containing insulin-producing beta cells) from a donor pancreas into a recipient with type 1 diabetes. The transplanted islets engraft in the liver or other sites and begin producing insulin in response to blood glucose levels, reducing or eliminating the need for exogenous insulin therapy. Success requires immunosuppression to prevent rejection of the allogeneic tissue.
Approved indications
- Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes
Common side effects
- Graft failure or loss of function
- Immunosuppression-related infections
- Immunosuppression-related malignancy
- Bleeding or thrombosis at transplant site
- Hyperglycemia recurrence
Key clinical trials
- SGLT2i Therapy in Islet Transplantation (SIT) (PHASE4)
- Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM (NA)
- Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
- Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye (PHASE1, PHASE2)
- Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) (PHASE1, PHASE2)
- A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus (PHASE1, PHASE2)
- A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation (PHASE1, PHASE2)
- Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Islet Cell Transplant CI brief — competitive landscape report
- Islet Cell Transplant updates RSS · CI watch RSS
- University of Illinois at Chicago portfolio CI
Frequently asked questions about Islet Cell Transplant
What is Islet Cell Transplant?
How does Islet Cell Transplant work?
What is Islet Cell Transplant used for?
Who makes Islet Cell Transplant?
Is Islet Cell Transplant also known as anything else?
What development phase is Islet Cell Transplant in?
What are the side effects of Islet Cell Transplant?
Related
- Manufacturer: University of Illinois at Chicago — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes
- Also known as: Allogeneic islets
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing