RecruitingNot ApplicableNCT06196996

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

Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus: A Clinical Study Evaluating Safety and Efficacy


Sponsor

Shanghai Changzheng Hospital

Enrollment

18 participants

Start Date

Sep 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a regenerative islet transplant approach for people with type 1 diabetes whose blood sugar remains dangerously uncontrolled despite taking insulin. It transplants insulin-producing cells (islets) from a donor pancreas into the patient to help restore natural insulin production. **You may be eligible if...** - You are 6–65 years old - You have type 1 diabetes with poor blood sugar control (HbA1c ≥7.5% or time in range <70%) despite intensive insulin therapy - Your body still produces some insulin (fasting C-peptide >0.1 nmol/L) - Your daily insulin dose is less than 0.5 units per kg of body weight - You are willing to use the study's blood glucose monitoring device **You may NOT be eligible if...** - You have no remaining insulin production - You have participated in another research study recently - You are pregnant or planning to become pregnant without using reliable contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThe method of islet transplantation is through percutaneous transhepatic portal vein puncture.

The method of islet transplantation is through percutaneous transhepatic portal vein puncture.After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy.


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT06196996