2023 The Final Countdown, page-1282

Mesoblast passed their phase 3 trial so I am guessing they don't fit into your categorisation in the above post .... oh but do tell us how it was an open label trial while at the same time defending the recent FDA approval of Lantidra with exactly that - single arm non-randomised trials with only 30 participants (15 each)





https://www.fda.gov/news-events/pre...llular-therapy-treat-patients-type-1-diabetes

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes


The safety and effectiveness of Lantidra was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions. Overall, 21 participants did not need to take insulin for a year or more, with 11 participants not needing insulin for one to five years and 10 participants not needing insulin for more than five years. Five participants did not achieve any days of insulin independence.