Stem-cell-derived islet clusters (Seraxis SR-02)
Seraxis
Seraxis SR-02 is allogeneic pancreatic endocrine cell clusters grown from a proprietary stem-cell line and implanted into the omentum (the fatty apron in the abdomen), where they aim to form a functional mini-pancreas. It has FDA clearance to begin a Phase 1/2 trial in severe T1D and still uses immunosuppression; a gene-edited, immunosuppression-free successor (SR-03) is planned.
The scorecard
No human data yet — the Phase 1/2 trial is FDA-allowed but not yet started, so insulin independence in people with T1D is unproven and scored on potential only.[1]
Durability rests on preclinical and manufacturing data; the omentum site is intended to support stable engraftment, but no human durability has been demonstrated.[1]
SR-02 requires standard immunosuppression to prevent rejection of the allogeneic cells; the immunosuppression-free advance is deferred to the separate gene-edited SR-03 program.[3]
Cells are surgically implanted onto the omentum (a laparoscopic abdominal procedure) rather than infused, making it more invasive than a portal-vein infusion, though the site is accessible.[1]
Initial trial targets only severe T1D with hypoglycemia, and nothing is available yet; an unlimited stem-cell source could broaden eligibility later if efficacy is shown.[1]
Earliest-stage of the cell-replacement candidates here: FDA IND allowed (Oct 2024), Phase 1/2 registered but not yet recruiting (~9 planned participants); no clinical readouts.[2]
The full picture
Seraxis is pursuing a manufactured, off-the-shelf islet replacement for type 1 diabetes. Its lead candidate, SR-02, is made of allogeneic pancreatic endocrine cell clusters grown at clinical scale from a proprietary stem-cell line that the company reprogrammed from healthy donor pancreas tissue. The aim is an essentially unlimited supply of insulin-producing cells, sidestepping the scarcity of deceased-donor pancreases that limits conventional islet transplants.
What distinguishes SR-02 from liver-infusion approaches is the implantation site. Rather than delivering cells into the hepatic portal vein, Seraxis places the clusters onto the omentum — the fatty, blood-vessel-rich apron of tissue in the abdomen — where they are intended to engraft and organize into a functioning endocrine pancreas outside the native organ. This site is surgically accessible and potentially supportive of long-term graft survival.
SR-02 is at an early stage. The U.S. FDA allowed its investigational new drug application in late 2024, clearing a Phase 1/2 study in adults with severe type 1 diabetes and hypoglycemia, but that trial has not yet begun enrolling and no human results exist. SR-02 also still relies on standard immunosuppression. Seraxis is separately developing a gene-edited successor, SR-03, engineered so anti-rejection drugs would not be needed, with a clinical trial targeted to begin in 2026.
Coming soon
ETA · FDA IND-allowed Phase 1/2 not yet recruiting; first human data years away. Gene-edited, immunosuppression-free SR-03 trial targeted to start 2026
- →Start of the first-in-human Phase 1/2 trial of SR-02 in adults with type 1 diabetes
- →Gene-edited successor SR-03, engineered so anti-rejection immunosuppressants are not needed, with a clinical trial targeted to begin · 2026
Sources
- [1]Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes · manufacturer · 2024-10-01
- [2]Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes (Seraxis SR-02; NCT07581197) · registry
- [3]Breakthrough T1D — Cell therapies in clinical trials for type 1 diabetes (Seraxis SR-02 / SR-03 overview) · news