The investigational cell therapy donislecel demonstrated a favorable risk-benefit profile for certain patients with difficult-to-control type 1 diabetes.
There is nothing patients [with diabetes] like more than freedom from dealing with the entire insulin issue.
This therapy can help some patients and will be incredibly meaningful to those who receive it.
Donislecel (Lantidra, CellTrans) — an allogeneic pancreatic islet cellular therapy — has been shown to increase insulin independence and decrease the number of severe hypoglycemic events among patients with difficult-to-control type 1 diabetes, based on pooled results of two open-label studies.
The therapy comprises islet cells isolated from a single donor pancreas. The final cultured cell product is transplanted through infusion in the hepatic portal vein via percutaneous or transvenous transhepatic access or — if these are not feasible —via laparoscopic or open surgical access.
The data on sustained insulin independence are compelling,
also The results meet the minimum 4-year insulin-independence benchmark for providing clinically impactful benefit that the panel had agreed to earlier.
Finally, The evidence suggests that many patients have benefited from this type of transplantation , even if the market size for this therapy might decline over time.