OPF-310 encapsulated porcine islets for unstable T1D

What is being tested, and why it matters

Every islet-transplant approach runs into the same wall: there are not enough human donor pancreases to treat more than a tiny fraction of people with type 1 diabetes. Xenotransplantation — using cells from another species — is one way around that. Pigs can be bred in large numbers under controlled conditions, and neonatal pig islets make insulin that works in humans (pork-derived insulin was used clinically for decades before synthetic human insulin). OPF-310 is Otsuka's investigational product: porcine islet cells sealed inside a capsule and transplanted without immunosuppressive drugs.¹

The capsule is the whole idea. A pig cell dropped into a human body without protection would be destroyed quickly. The bet is that a physical barrier can let glucose, oxygen and insulin pass through while keeping immune cells and antibodies out — so the graft survives without the lifelong immunosuppression that makes conventional islet transplants a hard trade for most people. That is why participants must not be on immunosuppressive medication to enter.¹

What the capsule is made of — an open question

Otsuka has not publicly disclosed the encapsulation material or device.² There is a strong hint in the protocol: the trial excludes anyone with an "alginate/seaweed allergy," alongside pork and porcine-insulin allergy.¹ Alginate — a gel derived from seaweed — is the classic islet-encapsulation material, and the same sponsor lineage (Diatranz Otsuka / Living Cell Technologies) previously ran DIABECELL, a trial explicitly titled Immunoprotected (Alginate-Encapsulated) Porcine Islets for Xenotransplantation.³ Taken together, alginate looks very likely. But that is our inference from an exclusion criterion and company history, not a statement from Otsuka, and it should be read as such until the company or a published paper says otherwise.

Who it is for

This trial is aimed at a narrow, high-risk group: adults aged 35–65 who have lived with type 1 diabetes for at least 5 years, have essentially no insulin production of their own left (C-peptide below 0.3 ng/mL), have an HbA1c of 9.0% or less and a BMI of 27 or less, and have already been on a closed-loop system for at least 6 months and are still having dangerous lows.¹

"Still having dangerous lows" is defined three ways, and meeting any one of them qualifies: at least three level-3 (severe — needing someone else's help) hypoglycemic episodes in the past year; or one such episode plus impaired awareness of hypoglycemia (a Clarke score of 4 or more); or spending more than 1% of the time below 70 mg/dL (3.9 mmol/L) plus impaired awareness.¹ You do not need to have had three severe episodes to be eligible. Prior transplant of any kind rules a person out, as do pork, porcine-insulin and alginate/seaweed allergies.¹

How the study is designed

It is a Phase 1/2a study, open-label and single-arm — everyone who enrolls gets OPF-310; there is no placebo group and no blinding.¹ Enrollment is 13 participants at one site, the University of Illinois Hospital in Chicago. The trial started on 10 June 2025 and is currently recruiting, with primary completion scheduled for 30 June 2027.¹

The primary endpoint is unusually specific, and worth reading closely, because it sets the bar for what "success" means here. A participant counts as reaching the efficacy goal only if, at one year, all three of these are true: HbA1c below 7.0%; HbA1c down by at least 0.5 percentage points from their own baseline; and no level-3 severe hypoglycemic episode between week 12 and week 52 after transplant.¹ Note what that is not: it is not insulin independence. The goal is safer, steadier control in people whose lows are currently dangerous — not getting off insulin.

What it means, honestly

Encapsulated pig islets are not a new idea, and that cuts both ways. It means the concept has been through human hands before; it also means it has not worked well enough to become a therapy. DIABECELL, the alginate-encapsulated porcine islet product from the same sponsor lineage, went through Phase 1/2 trials that wrapped up more than a decade ago.³ No encapsulated porcine islet product is approved anywhere today, and OPF-310 is being run as a fresh first-in-human study — which tells you the earlier work did not deliver a durable therapy. Anyone reading this trial as "pig islets are about to cure type 1 diabetes" is reading it wrong.

What OPF-310 would prove, if it works, is significant on its own terms. It attacks the cell-supply problem (pigs, not donors), and it attacks the immunosuppression problem (a capsule, not drugs) — two of the hardest bottlenecks on the road to a cure. But with 13 people, no control group, a company that has not said what the device is made of, and no data due before mid-2027, this is an early signal to watch, not a result to plan around.

References

1. Otsuka Pharmaceutical Factory, Inc. A Phase I/IIa Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] (design, eligibility, endpoints, sites, status). ClinicalTrials.gov, NCT06575426. https://clinicaltrials.gov/study/NCT06575426 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹

2. type1strong. New Type 1 Diabetes Trial Using Pig Islets (Aug 18, 2025) — notes that Otsuka has not disclosed the encapsulation device type. https://www.type1strong.org/blog-post/new-type-1-diabetes-trial-using-pig-islets ↩

3. Diatranz Otsuka Limited. DIABECELL: A Phase I/IIa Open-label Investigation of Immunoprotected (Alginate-Encapsulated) Porcine Islets for Xenotransplantation. ClinicalTrials.gov, NCT00940173. https://clinicaltrials.gov/study/NCT00940173 ↩ ↩²