Hey readers! Every implanted cell therapy for type 1 diabetes has run into the same wall: the body wraps the device in scar tissue and starves the cells inside. This week, Encellin reported something unusual from its first human trial - the scar simply did not form. Let's get into what that means, and round up a busy fortnight of Tzield approvals, inhaled insulin for kids, and closed-loop news.
🧫 The headline: Encellin's implant avoided the scar
Encellin's diabetes implant shows non-fibrotic engraftment in phase 1 reports first-in-human Phase 1 data, presented at the ISSCR 2026 Annual Meeting, showing that all seven adults who received Encellin's subcutaneous encapsulated cell replacement therapy (ENCRT) achieved durable, non-fibrotic engraftment of donor islets without lifelong immunosuppression. - Scienmag
Here is why this is worth your attention. The central problem with putting insulin-producing cells under the skin has always been the foreign body response: a dense collagen scar that walls off the implant, cuts it from the blood supply, and kills the cells. Encellin reported that explanted devices and imaging showed an absence of that fibrotic capsule, while histology found host microvessels penetrating the device periphery and insulin-positive islet clusters still viable at analysis.
"The field has made important advances in developing insulin-producing cells but delivering those cells safely and durably without lifelong immunosuppression remains one of the central challenges," said Crystal Nyitray, Ph.D., CEO and Founder of Encellin. "These clinical findings represent encouraging progress toward addressing that challenge and provide evidence that our approach may support engraftment and vascularization without the fibrotic response that has historically limited implanted cell therapies."
A few honest caveats, because they matter. This was an open-label study of seven people, and the primary endpoint was safety and tolerability, not efficacy. That means the trial was not designed to show whether these islets actually improved blood sugar or reduced insulin needs. As Mirage News notes, the results build on interim findings first reported in January 2026, transplanted islets were identified in multiple participants, and full-dataset analysis is still ongoing. Encellin says larger, controlled studies with prespecified efficacy measures and longer follow-up on durability and immune sensitization are still needed. So: promising engraftment biology, not yet proof of a functional treatment.
What makes the platform interesting beyond diabetes is that it is a delivery vehicle. If cells can survive and get vascularized under the skin without a scar or immunosuppression, the same device could in principle host stem cell-derived islets or other protein- and hormone-producing cells for chronic diseases. For now, the takeaway for people living with T1D is measured optimism: a longstanding barrier looks more approachable than it did, and the next studies will tell us whether that translates into insulin your own implant makes.
🛡️ The other side of the rejection problem: hiding the cells
Encellin's approach is essentially mechanical - a device that physically protects islets. A parallel line of work presented at the same ISSCR meeting tries to solve rejection at the cellular level instead.
New first-in-human study explores immune-engineered cell therapy describes a trial of allogeneic, hypoimmune-engineered insulin-producing cells designed to survive and function without chronic immunosuppression. - Medical Xpress
"Type 1 diabetes is still treated primarily by replacing insulin, not by replacing the insulin-producing cells that were lost," said Sonja Schrepfer, M.D., Ph.D., of Cedars-Sinai Medical Center and guest professor at Uppsala University, who presented at the meeting. "This would be an important step toward a functional cure by replacing the insulin-producing cells that were lost, restoring biological insulin production, and reducing the daily burden of disease management for patients."
A companion writeup at News USA Today frames the appeal and the risk together: making cells invisible to the immune system removes the need for toxic immunosuppressants, but it also raises the bar on safety monitoring.
If you make cells invisible to the immune system, you must be absolutely certain that they do not become malignant or behave in unexpected ways.
A third strategy worth flagging comes from UCSF's CAR-Treg trial, a Phase 1 study that engineers a patient's own regulatory T cells to target pancreatic antigens and create a localized tolerant environment, borrowing CAR technology from oncology. Three different bets on the same core problem - rejection - and it is genuinely useful that the field is not putting all its chips on one approach.
💉 Tzield goes to more kids, and reaches real patients
While cell therapy makes headlines, the disease-modifying drug already in clinics kept expanding this month.
FDA Approves Tzield for Children With New Stage 3 Type 1 Diabetes covers the accelerated approval of teplizumab-mzwv for children ages 8 to 17 recently diagnosed with stage 3 T1D, based on the PROTECT phase 3 study of 328 children. - Ophthalmology Advisor
PROTECT showed a significant slowing of the decline in mean C-peptide versus placebo, meaning kids held onto more of their own insulin production. It is not without tradeoffs: common adverse events included lymphopenia and rash, and serious events such as cytokine release syndrome and life-threatening viral reactivation have been reported. This is a real drug with real risks, not a cure.
What this looks like on the ground: a Lincoln Parish teen became the first person in Louisiana and fourth in the world to receive Tzield for stage 3 disease, a $14,000 regimen he was set to finish on July 15.
"Type 1 diabetes now has stages and many people don't know that yet," one clinician said. "If we can catch it earlier, prevent DKA and delay progression for someone else, that's a win for every family."
A few more pieces of the Tzield picture:
UC Davis Health now offers Tzield for stage 2 and stage 3 T1D in adults and children age 1 and older, delivered as daily IV infusions over 14 days, and is emphasizing screening for first-degree relatives.
In England and Wales, NICE recommended teplizumab to delay symptomatic T1D by nearly three years on average for people in stage 2, with NHS access rolling out over specified timelines.
On the business side, MacroGenics is set to receive a $24.5 million milestone payment from Sanofi tied to the accelerated approval.
The common thread across all of these: none of it works without early screening, because stage 2 usually has no symptoms.
🫁 Needle-free insulin for kids
Afrezza Rapid-Acting Inhaled Insulin Now Approved for Children and Adolescents reports MannKind's inhaled mealtime insulin was FDA-approved on May 29, 2026 for kids ages 6 and older, based on the Phase 3 INHALE-1 trial. - The Educated Patient
Inhaled insulin peaks within 35 to 45 minutes and clears within 1.5 to 3 hours, which trims the long "tail" of injected insulin. In INHALE-1 it was comparable to injections on A1c and time-in-range over 26 weeks. Worth noting: baseline spirometry is required, and it is contraindicated for children with asthma or reactive airway disease.
The companion family story is a good reminder of what the emotional burden of visible diabetes care looks like for a teenager:
"She wasn't missing out on snacks or desserts or anything like that because she didn't want to do another shot. She just kind of got to be a kid."
⚙️ Devices and data worth a scroll
Diabeloop's DBLG2 automated insulin delivery algorithm is now open for prescription in Germany with the Dexcom G7 and ViCentra's Kaleido patch pump, running on a smartphone and adjusting insulin every five minutes without mandatory meal announcements.
The FDA cleared the Tandem t:slim X2 with Control-IQ+ for use in pregnancy, based on the CIRCUIT trial, which showed 65.4% time in the tight pregnancy range versus 50.3% with standard care and lower preeclampsia rates (14% vs 25%).
NICE draft guidance recommends pregnancy-specific hybrid closed-loop technology for pregnant women with T1D and those planning pregnancy, requiring devices to deliver at least 5% more time in range than standard care.
Health Canada authorized Dexcom's G7 15 Day CGM for adults, offering 15.5-day wear, though it is not yet available for purchase there.
New JAMA Network Open data from a Montefiore cohort of 8,502 adults found CGM started in primary care was linked to a larger A1c drop and 13% fewer recurrent hospitalizations.
That's the issue. Between a scar-free implant, three shots at solving rejection, and Tzield reaching its fourth patient worldwide, the through-line is clear: the field is chasing the cells, not just the insulin. As always, talk to your care team before changing anything - this is news, not medical advice. See you next time.