TUFF-IPC Phase 1/2a: autologous adipose-derived insulin-producing cells
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-16. Registry’s own update: 2026-05-18.
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 at a glance
- Who can enter the study?
- Adults aged 18–65 with type 1 diabetes, insulin dependence for more than five years, fasting C-peptide below 0.1 ng/mL, extremely difficult glucose control despite intensive treatment, and at least one severe hypoglycemic episode in the preceding 12 months. Tokushima University Hospital, Japan. See the jRCT record for all criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The checked jRCT record lists recruiting, target n=3, first registration 18 September 2025 and last public update 18 May 2026. First participant enrolment was 27 January 2026. Exploratory engraftment is defined as fasting C-peptide of at least 0.3 ng/mL (approximately 0.1 nmol/L) at specified follow-up visits. No results are posted in the checked record; a protocol threshold is not an observed result or insulin independence.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Japan. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Safety (adverse events and device deficiencies) from pretreatment before fat collection through day 60 after laparoscopic transplantation
The full picture
TUFF-IPC is a three-person, single-arm first-in-human protocol using cells derived from each participant’s own adipose stem cells. Its small planned enrollment and safety-first design cannot establish effectiveness. Results from other cell products cannot substitute for this trial’s outcomes.1
Sources
- [1]jRCT2063250055: TUFF-IPC autologous adipose-derived IPCs in T1D · Trial registry · 2026-05-18
jRCT2063250055. Study design, eligibility, intervention and outcomes; last public update 18 May 2026.