Skip to content
type1.science
N/A (device / behavioral)Not yet recruitingNCT07464119

iPSC-derived islet cells for diabetes (Peking University First Hospital)

A 30-person, single-arm, open-label study of infused iPSC-derived islet cells, run by Peking University First Hospital with Hangzhou Reprogenix — the company behind the celebrated Chinese "cured with her own cells" case. As of 15 July 2026 it is registered but **not yet recruiting**: nobody has been dosed. Two things are worth getting right before this one reaches the headlines. It is registered at phase **NA**, not Phase 1. And it is not an immunosuppression-free trial: the registry describes no drug-free protocol, and cells grown from a patient's own body answer rejection, not the autoimmunity that caused type 1 diabetes in the first place.

Primary endpoints

  • Adverse events, from enrolment to month 6

Results so far

No results, and no participants. 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 without recruitment opening. 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.

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.

Nobody has been dosed. As of 15 July 2026 the status is not yet recruiting. The registered start date of 16 March 2026 has come and gone without recruitment opening. Zero participants have 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:

  1. Allo-rejection — the immune system attacking tissue from another person. Autologous cells genuinely solve this.
  2. Autoimmunity — the thing that destroyed the beta cells in the first place. Those memory T cells are still present, still primed, still specific to beta-cell antigens. A perfectly matched autologous graft is precisely the target they were trained on.

Autologous cell therapy answers the first and is silent on the second. That silence is why the two celebrated Chinese cases are not what they were reported to be: both patients were already on chronic systemic immunosuppression for a prior liver transplant. A peer-reviewed review of the first case says so directly — her transplant history was what let the team "leverage existing immunosuppressive therapy."3 The grafts went into immune systems that had already been chemically disarmed. No CiPSC islet graft has ever been observed surviving in an untreated type 1 immune system, in this trial or any other.

The bar, for reference

As of July 2026, exactly one human on earth has transplanted insulin-producing cells surviving with zero immunosuppression: the Sana UP421 patient — gene-edited donor islets, 14 months, reported in the NEJM in July 2026, n=1, at a deliberately sub-therapeutic dose, and still on insulin. Everything else, including this trial, is either drug-dependent or preclinical.

This study can make a real contribution to the cell-supply problem: islets manufactured on demand, with no donor. That is worth something. It cannot, and is not designed to, show that anyone can keep those cells without anti-rejection drugs.

References

  1. 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. https://clinicaltrials.gov/study/NCT07464119 ↩ ↩2 ↩3 ↩4 ↩5

  2. 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). https://doi.org/10.1016/j.cell.2024.09.004 ↩

  3. Lou Y. "Illuminating the future of diabetes treatment: Autologous CiPSC-derived islets take center stage." Cell Transplantation (2025). https://doi.org/10.1177/09636897251366828 ↩