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Phase 1/2RecruitingjRCT2063250055

TUFF-IPC Phase 1/2a: autologous adipose-derived insulin-producing cells

Recruiting Japanese first-in-human Phase 1/2a of TUFF-IPC, insulin-producing cells made from a person's own fat-derived stem cells, transplanted into the mesentery. Target n=3. Safety to day 60 is primary. No results posted.

Primary endpoints

  • Safety (adverse events and device deficiencies) from fat harvest through day 60 after transplant

Results so far

No results posted. Recruiting; target n=3; registered 18 September 2025; last updated 27 August 2026. Exploratory engraftment is defined as fasting C-peptide of at least 0.3 ng/mL (0.1 nmol/L). A registered protocol is not insulin independence.

The full picture

This is a three-person first-in-human surgical protocol, not a donor-islet or Vertex-style allogeneic programme. Do not score it from other adipose-stem-cell studies, including the Ain Shams youth trial (NCT06951074), and do not treat Type 2 adipose-cell work as evidence.