Skip to content
type1.science
Phase 1RecruitingNCT06731218

RGB-5088 autologous CiPSC-derived islet injection in T1D

Hangzhou Reprogenix's Phase 1 study of RGB-5088 — islets grown from the patient's own chemically reprogrammed (CiPSC) cells — in 10 adults with type 1 diabetes at Tianjin First Center Hospital. This is the clinical follow-up to the widely reported "cured with her own cells" case. Read the eligibility criteria carefully: the trial explicitly enrolls people who have already received a liver or kidney transplant, and are therefore already on chronic systemic immunosuppression. It is not a test of whether these cells survive without anti-rejection drugs.

Primary endpoints

  • Safety: number of participants with adverse events, from transplantation to one year
  • Proportion of participants with HbA1c 6.5% or below and free of severe hypoglycemic events, from day 90 to day 365

Results so far

No results posted. The registry lists the study as recruiting (checked 15 July 2026), single-arm and open-label, with 10 participants at one site; primary completion is estimated December 2027 and study completion December 2031. The published evidence for this platform is a single patient, reported in Cell in September 2024 — insulin-independent from day 75 and still off insulin at one year — who was already on chronic systemic immunosuppression for a previous liver transplant.

The full picture

What is being tested

RGB-5088 is an autologous islet product: the participant's own cells are chemically reprogrammed to pluripotency (CiPSC), differentiated into islets, and transplanted back. The Phase 1 is single-arm, open-label, and enrolls 10 adults aged 18-60 with type 1 diabetes, stimulated C-peptide under 0.3 ng/mL, and at least one severe hypoglycemic event in the previous year, at Tianjin First Center Hospital.1

The eligibility line that matters

The registry's inclusion criteria read: "Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney)."1

People who have had a liver or kidney transplant are, without exception, on chronic systemic anti-rejection drugs. Enrolling them is not an oversight — it mirrors the published case that made this platform famous. In Cell (September 2024), the team reported a woman with T1D who was insulin-independent from day 75 and still off insulin at one year after receiving CiPSC islets.2 She had already received a liver transplant, and the graft went into an immune system that was already being suppressed for it; a peer-reviewed review of the case states that her transplant history was what allowed the team to "leverage existing immunosuppressive therapy."3

What this trial can and cannot show

It can show that islets grown from a person's own chemically reprogrammed cells can be manufactured, engrafted under the rectus sheath, and restore glucose control — which would be a serious advance on the cell-supply problem, because it needs no donor.

It cannot show that those cells survive without immunosuppression. Autologous cells solve allo-rejection; they do nothing about the autoimmunity that destroyed the person's beta cells in the first place, and a perfectly matched graft is exactly what those memory T cells were trained to attack. No CiPSC islet graft has ever been observed in an untreated type 1 immune system, in this trial or anywhere else. Anyone reading "her own cells, no rejection" as "no drugs" has the wrong end of the result.

References

  1. Hangzhou Reprogenix Bioscience. "A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus." ClinicalTrials.gov NCT06731218. Checked 15 July 2026: recruiting, 10 participants, Tianjin First Center Hospital, start February 2025, primary completion estimated December 2027. https://clinicaltrials.gov/study/NCT06731218 ↩ ↩2

  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 (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 ↩