Autologous Islet Transplantation for Diabetes

Early Phase 1Enrolling By InvitationNCT07118475

Shanghai Zhongshan Hospital24 enrolled

Overview

This study aims to conduct an exploratory clinical trial recruiting insulin-dependent diabetic patients who meet the criteria for islet transplantation. Pancreatic tissue will be obtained via endoscopic ultrasound-guided fine-needle aspiration biopsy, and adult pancreatic progenitor cells (APP) will be expanded in vitro and differentiated into islet-like cells. After quality assessment, these cells will be transplanted via injection beneath the anterior rectus sheath. Following autologous transplantation of APP-derived islets, the transplanted islets are expected to survive at the implantation site, stably secrete insulin, and thereby reduce or potentially eliminate the need for exogenous insulin. Glycated hemoglobin (HbA1c) levels are anticipated to decrease, with a significant reduction in the risk of severe hypoglycemic episodes, and no transplant-related adverse events are expected. As this is an exploratory clinical study, participants may not benefit from APP islet transplantation and may face risks or adverse events associated with the procedure. However, the findings of this research may advance more scientific and effective treatment strategies for diabetes. The successful completion of this study could provide a feasible and scalable approach to functionally curing diabetes, effectively reducing disability and mortality rates among diabetic patients, improving their quality of life, and generating substantial health, economic, and social benefits.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diabetic patients with islet transplantation indications 2. Dependent on exogenous insulin therapy 3. C-peptide \<0.3 ng/ml or blood glucose control remains unsatisfactory despite intensive insulin therapy. Exclusion Criteria: 1. Unable to tolerate transplant related procedures for various reason 2. Persons with a history of infectious diseases such as hepatitis B, hepatitis C, HIV and tuberculosis, or persons with active bacterial, fungal or viral infection 3. Heart, liver and kidney dysfunction or significant decrease in blood cells 4. Previous cancer history 5. Researcher-deemed ineligible for this clinical trial due to other reasons.

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Adverse events will be coded according to the MedDRA dictionary, and AE will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 of the National Cancer Institute.