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Phase 3CompletedNCT00434811

Lantidra (donislecel): purified allogeneic islet cell therapy (CIT-07)

CIT-07 was the pivotal Phase 3 trial that proved transplanted donor islet cells can restore blood-sugar control and stop dangerous low-blood-sugar episodes in adults with hard-to-control type 1 diabetes — the science behind Lantidra, the first FDA-approved cell therapy for T1D.

Primary endpoints

  • Achieving HbA1c below 7.0% (53 mmol/mol) at day 365 AND freedom from severe hypoglycemic events from day 28 to day 365 after the first islet transplant

Results so far

87.5% of participants met the primary goal at 1 year (good glucose control with no severe lows), and 71% still met it at 2 years. Median HbA1c fell to 5.6% at both 1 and 2 years, hypoglycemia awareness was restored, and there were no study-related deaths. Bleeding from the procedure (10.4%) and immunosuppression-related infections and reduced kidney function were the main risks.

The full picture

What was tested and why it matters

Some people with type 1 diabetes lose the ability to feel a dangerous low blood sugar coming on — a condition called impaired hypoglycemia awareness. Even with the best modern care, 20-50% of them keep having severe lows that can cause seizures, coma, or death.1 CIT-07 asked a direct question: can transplanting insulin-making islet cells from a deceased donor's pancreas stop these episodes and restore blood-sugar control?1

This trial matters because it became the scientific foundation for Lantidra (donislecel) — the first cell therapy ever approved by the FDA for type 1 diabetes, cleared in June 2023.2

Who it was for

Forty-eight adults who had lived with type 1 diabetes for more than 5 years, made essentially no insulin of their own, and were still suffering severe lows despite expert intensive management.1

How it was designed

CIT-07 was a multicenter, single-arm Phase 3 study run at eight transplant centers across the United States and Canada by the NIH-funded Clinical Islet Transplantation Consortium.1 There was no placebo group — each participant served as their own comparison, measured against their condition before transplant.1 Participants received one or more infusions of purified human pancreatic islets, made on-site under strict pharmaceutical-grade manufacturing standards, plus immunosuppressive drugs to prevent rejection.1 The main goal was, at 1 year, to reach an HbA1c under 7.0% and have no severe low-blood-sugar events from day 28 to day 365.1

Key results

The therapy worked for most people. 87.5% of participants met the combined goal at 1 year, and 71% still met it at 2 years.1 The median HbA1c dropped to 5.6% — squarely in the non-diabetic range — at both 1 and 2 years, and the ability to sense oncoming lows was restored.1 There were no study-related deaths or permanent disabilities.1 The main harms were bleeding from the liver-infusion procedure (about 10% of people), infections linked to immunosuppression, reduced kidney function, and antibody sensitization in two people.1 Participants also reported large, lasting improvements in diabetes-related distress, fear of hypoglycemia, and overall quality of life.3

What it means and what's next

CIT-07 proved donor islet transplantation can free high-risk patients from severe lows.1 Its main limitation is the need for lifelong immunosuppression and the scarcity of donor pancreases — so the field is now racing toward an unlimited, stem-cell-derived islet supply that ideally needs no immune suppression.1

References

  1. Hering BJ, Clarke WR, Bridges ND, et al. Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care (2016);39(7):1230-40. According to PubMed. https://doi.org/10.2337/dc15-1988 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12 ↩13

  2. Latres E, et al. Donislecel: First Cellular Therapy to Treat Patients With Brittle Type 1 Diabetes (review of the FDA approval of Lantidra, June 28, 2023). PubMed Central PMC11060608. https://pmc.ncbi.nlm.nih.gov/articles/PMC11060608/ ↩

  3. Foster ED, Bridges ND, Feurer ID, et al. Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care (2018);41(5):1001-1008. According to PubMed. https://doi.org/10.2337/dc17-1779 ↩