An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events

NCT07503028 · Enrolling by invitation

Last updated 2026-09-22

This clinical trial is testing the safety of lab-made pancreatic cells (CRG-002) derived from stem cells in people with type 1 diabetes or diabetes caused by pancreas damage who experience frequent or severe low blood sugar.

Status Enrolling by invitation Only people invited by the researchers can join.

Phase Early Phase 1 First exploratory testing in people.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 10 people Planned (estimated).

Who can join Ages 18–70 · all sexes

Timeline Started 2025-10 · est. completion 2028-01

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07503028 ↗

Description as written by the study sponsor.

This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in patients with type 1 diabetes mellitus (T1DM) or pancreatogenic diabetes who have hypoglycemia unawareness or severe hypoglycemic events.

Treatments tested

CRG002 Drug

Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

Main thing measured	Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
Sponsor	Celregen Therapeutics
Conditions studied	T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07503028 ↗