TUFF-IPC autologous adipose-derived insulin-producing cells
Investigator-led (Tokushima)
What it is
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.
Editorial review: .
Most recent recorded citation date: 2026-05-18. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Insulin independence: No human result is posted. Insulin independence is an exploratory hope, not a measured outcome.[1]
- Important harms and treatment burden
- Immunosuppression-free: 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]
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Protocol follow-up for efficacy markers runs to 360 days. Nothing has been shown to last.[1]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 5 × 30 + 5 × 20 + 40 × 20 + 22 × 10 + 12 × 10 + 20 × 10 = 1590; divide by total weight 100. Unrounded weighted result: 15.9.
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, ages 18–65 inclusive, 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 · Trial 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).