TUFF-IPC autologous adipose-derived insulin-producing cells
Investigator-led (Tokushima)
A Japanese first-in-human Phase 1/2a trial of a person's own fat-derived stem cells turned into insulin-producing cells (TUFF-IPC) and placed in the mesentery. Target enrolment is three people. No results are posted.
The scorecard
No human result is posted. Insulin independence is an exploratory hope, not a measured outcome.[1]
Protocol follow-up for efficacy markers runs to 360 days. Nothing has been shown to last.[1]
The product is autologous, so allo-rejection is not the design problem. The public protocol does not state a drug-free regimen, and autoimmunity is not solved by using the recipient's own fat cells.[1]
Fat harvest plus laparoscopic placement into the mesentery near the ligament of Treitz is surgery, not an infusion.[1]
First-in-human, target n=3, age under 65, Tokushima only. Not a path most people with T1D can enter.[1]
Registered recruiting Phase 1/2a (jRCT2063250055). First participant enrolled 27 January 2026; last jRCT publication 18 May 2026. A first enrollment date is not a C-peptide result.[1]
The full picture
TUFF-IPC is an autologous adipose-to-islet programme: a person's own fat-derived stem cells are differentiated toward insulin-producing cells and transplanted laparoscopically into the mesentery. Because the cells are the recipient's, this is not a donor-islet shortage story — and it is also not proof that autoimmunity will leave the graft alone.
The only registered study is a three-person first-in-human trial in Tokushima (jRCT2063250055), recruiting as of a live check on 27 August 2026. The registry's own last publication date is 18 May 2026; the first participant was enrolled on 27 January 2026. Safety to day 60 is the primary endpoint. Fasting C-peptide of at least 0.3 ng/mL (0.1 nmol/L) is the protocol's engraftment mark, not a posted result. Do not read a Japanese registry listing, or a first-enrollment date, as insulin independence.
Coming soon
ETA · Phase 1/2a recruiting in Tokushima; first enrolled 27 Jan 2026; n=3; no efficacy timeline
Sources
- [1]jRCT2063250055 — investigator-initiated FIH of autologous adipose-derived insulin-producing cells in type 1 diabetes · registry · 2026-05-18 — Recruiting (募集中). Target n=3. First enrollment 27 January 2026; last jRCT publication 18 May 2026 (Reiwa 8-05-18). Ages 18–65. Dose 1,100–1,500 IE/kg into mesentery. Primary endpoint is safety to day 60 after transplant. Engraftment defined as fasting C-peptide at least 0.3 ng/mL (0.1 nmol/L). Inclusion also requires at least one severe hypoglycaemia in 12 months, defined in part as needing assistance with glucose ≤60 mg/dL (3.3 mmol/L).