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Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 9, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Dec 2023); last known: Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the treatment of brittle type 1 diabetes mellitus. Eighteen patients with brittle type 1 diabetes mellitus, who have inadequate blood glucose control despite intensified exogenous insulin therapy, will be enrolled. The primary endpoint is defined as the safety and improvement in blood glucose levels of the 12 months after allogeneic regenerative islet transplantation.
Trial Details
NCT Number NCT06196996
Lead Sponsor Shanghai Changzheng Hospital
Conditions
(from sponsor)		 Brittle Type 1 Diabetes Mellitus
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov