Autologous Islet Transplantation for Diabetes (APPITD)

Fudan University

Status and phase: Invitation-only; Early Phase 1

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

Treatments: Biological: Autologous islet transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07118475

B2025-257

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Autologous islet transplantation

Experimental group

Treatment:

Biological: Autologous islet transplantation