iPSC-derived islet cells for diabetes (Peking University First Hospital)
What this study tests
Registered single-arm study of infused iPSC-derived islet cells in an estimated 30 adults with longstanding insulin-treated diabetes. The registry lists phase N/A and not yet recruiting. It does not restrict the condition to T1D or establish an immunosuppression-free protocol; registration does not demonstrate treatment success.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-03-11.
Most recent recorded citation date: 2026-03-16. 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 18 or older, any sex, on insulin therapy, with diabetes of more than 5 years' duration and a BMI of 18-35 kg/m². Note that the registered condition is "Diabetes Mellitus" — the record does not restrict enrolment to type 1. Exclusions include HIV, active hepatitis B or C, syphilis, active tuberculosis, uncontrolled infection, severe diabetic complications, severe organ disease, and any history of malignancy. 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
- No results posted; enrollment remains an estimate. The registry lists the study as not yet recruiting as of 15 July 2026, with an estimated start date of 16 March 2026 that has passed, while the registry still lists not yet recruiting. Enrolment target is 30; primary completion is estimated December 2028 and study completion December 2033. Secondary endpoints are change from baseline in HbA1c and in exogenous insulin dose, both at 6 months — note that an insulin-dose *reduction* endpoint is not an insulin-independence endpoint.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: Other regions. 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
- Adverse events, from enrolment to month 6
The full picture
What is being tested
A single-arm, open-label study of iPSC-derived islet cells infused into 30 adults with diabetes, at Peking University First Hospital in Beijing, with Hangzhou Reprogenix Bioscience as collaborator.1 Reprogenix is the company behind the chemically induced pluripotent stem cell (CiPSC) islets reported in Cell in 2024 — the case that travelled the world as the woman "cured of type 1 diabetes with her own cells."2 This is the next step in that programme.
The primary endpoint is safety: adverse events from enrolment to month 6. Change in HbA1c and change in exogenous insulin dose are secondary, also at 6 months.1
Read the registry before the headlines
Four details in the record are easy to lose and worth stating plainly.
Recruitment is not confirmed. The registry remains not yet recruiting despite a passed estimated start date. That is the reported status, not independent confirmation that no one has received cells.1
It is registered at phase NA, not Phase 1. Do not upgrade it. Primary completion is estimated December 2028, with follow-up running to December 2033.1
The registered condition is "Diabetes Mellitus", not type 1. Eligibility is diabetes of more than 5 years' duration, on insulin, BMI 18-35 kg/m². Nothing in the record restricts enrolment to type 1, and nothing on this site scores a type 1 record on evidence that may not be type 1.1
The registry does not say the cells are autologous. The intervention is listed only as "iPSC-derived islet cell". Given the collaborator, the autologous CiPSC platform is the obvious inference — but it is an inference, and we mark it as one.
This is not a drug-free trial
The registry describes no immunosuppression-free protocol. It describes no immunosuppression protocol at all. Absence of a mention is not evidence of absence of drugs, and it is certainly not evidence of freedom from them.
More fundamentally, "your own cells" was never an answer to immunosuppression in type 1 diabetes. A transplanted islet faces two enemies:
- Allo-rejection — the immune system attacking tissue from another person. Autologous cells can avoid this allo-rejection risk in principle.
- Autoimmunity — the process that destroyed the beta cells in the first place. Memory T cells specific to beta-cell antigens may persist, so a perfectly matched autologous graft presents the same antigens the autoimmune response originally targeted.
Autologous origin may reduce allo-rejection risk, but does not establish protection from recurrent autoimmunity. The separate published T1D case involved a patient already receiving immunosuppressive therapy in connection with a prior liver transplant; that case therefore cannot on its own demonstrate drug-free graft survival.23
The bar, for reference
As a point of contrast sometimes cited: a single reported case — the Sana UP421 recipient, described in the NEJM in July 2026 as gene-edited donor islets surviving without immunosuppression at 14 months (n=1, at a deliberately sub-therapeutic dose, and still on insulin per that report; not verified against a primary source in this review). A single reported case does not establish a general result, and it does not change what this registry entry can show.
This study could still contribute to the cell-supply question: islets manufactured on demand, with no donor. That is worth something. But with a 6-month adverse-event primary endpoint and no immunosuppression regimen described in the record, it is not designed to show that anyone can keep those cells without anti-rejection drugs.
Sources
- [1]A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus (NCT07464119) · Trial registry · 2026-03-16 — Registry record retrieved 15 July 2026: status NOT_YET_RECRUITING; phase NA; interventional; enrolment 30; sponsor Peking University First Hospital, collaborator Hangzhou Reprogenix Bioscience, Inc; single site in Beijing; primary completion 31 December 2028, study completion 31 December 2033. Primary outcome is adverse events to month 6. Condition listed as "Diabetes Mellitus". Intervention listed as "iPSC-derived islet cell", with no statement of autologous vs allogeneic and no immunosuppression regimen.
Peking University First Hospital (collaborator: Hangzhou Reprogenix Bioscience, Inc). "A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus." ClinicalTrials.gov NCT07464119. Record retrieved 15 July 2026: not yet recruiting; phase NA; enrolment 30; single site, Beijing; primary completion estimated 31 December 2028; study completion 31 December 2033.
- [2]Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient · Peer-reviewed study · 2024-09-25 — Wang S, Du Y, ... Deng H, Shen Z. Cell 187(22):6152-6164. The single-patient CiPSC islet result from the Peking University / Reprogenix collaboration that this programme follows on from.
Wang S, Du Y, Zhang B, et al. "Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient." Cell 187(22):6152-6164 (25 September 2024).
- [3]Illuminating the future of diabetes treatment: Autologous CiPSC-derived islets take center stage · Peer-reviewed study · 2025-08-18 — "The first human trial involved a patient with a history of liver transplantation, allowing the team to leverage existing immunosuppressive therapy."
Lou Y. "Illuminating the future of diabetes treatment: Autologous CiPSC-derived islets take center stage." Cell Transplantation (2025).