Using islet organoids to treat diabetes after pancreatic surgery

The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes

This study is testing whether transplanting patients' own islet cells, grown in the lab, can help people with diabetes after they've had pancreatic surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06415643 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of transplanting autologous islet organoids, which are expanded in vitro, for treating pancreatogenic diabetes in patients who have undergone pancreatic surgery. The study will follow a single-center, single-arm design, focusing on the operational process of isolating, expanding, and transplanting islets from the participants' own pancreas. Investigators will also manage postoperative care and gather clinical experience to establish standardized procedures for this treatment method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with specific pancreatic conditions requiring surgery and no significant organ damage.

Not a fit: Patients with chronic organ failure or severe mental disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from diabetes related to pancreatic surgery.

How similar studies have performed: While the use of islet organoids is a novel approach, similar studies involving islet transplantation have shown promise in treating diabetes.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form and adhere to the trial treatment plan and visit schedule.
2. When signing the informed consent form, the age should be between 18-70 years old, with no gender restrictions.
3. Good overall health condition: no damage to important organs such as heart, lungs, liver, kidneys, no serious or uncontrolled infections, and no history of severe mental disorders.
4. Meets the diagnosis of pancreatic tumor, chronic pancreatitis (diffuse pancreatic duct stones, refractory pain, associated with high risk of pancreatic cancer), pancreatic trauma, postoperative pancreatic fistula with class C, pancreatic cystic fibrosis, has indications for total or subtotal pancreatectomy, and no chronic organ failure.
5. Clinical examinations must meet the following criteria: Normal glycated hemoglobin (HbA1c) measurement.
6. Normal alanine aminotransferase (ALT) measurement, or abnormal but clinically insignificant
7. negative for Hepatitis A virus antibody (HAV antibody), Hepatitis B virus surface antigen (HBsAg) and e antigen, Hepatitis C virus antibody (HCV antibody), Human Immunodeficiency Virus antibody (HIV-1 and HIV-2 antibody), Syphilis antibody, Epstein-Barr virus antibody (EBV antibody), Cytomegalovirus (CMV-DNA), B19 virus nucleic acid, Human T-lymphotropic virus antibody.
8. Male participants who are sexually active and have not undergone surgical sterilization or whose partners are capable of childbearing, agree to take effective contraceptive measures for the entire trial period and at least 6 months after the end of the study, and not to donate sperm. Female participants capable of childbearing agree to take effective contraceptive measures for the entire study period and at least 6 months after the end of the study.
9. Post-pancreatic surgery blood sugar increase, meeting the diagnostic criteria for diabetes (World Health Organization 2019 edition).
10. C-peptide level \<0.3 ng/mL 120 minutes after mixed meal stimulation before pancreatic islet transplantation.

Exclusion Criteria:

1. The investigator considers the following diseases to be clinically significant: a history of diabetes, or preoperative hyperglycemia, meeting the diagnosis of diabetes.
2. Undergone previous pancreatic or islet transplantation
3. Uncontrolled hypertension, such as systolic blood pressure (SBP) \>160 mmHg and/or diastolic blood pressure (DBP) \>100 mmHg after treatment with a stable dose (at least 4 weeks) of antihypertensive drugs.
4. Fatty hepatitis, portal vein thrombosis, portal hypertension, anterolateral pancreatic jejunostomy, or visceral hyperalgesia.Impaired liver and kidney function at screening (reference to the normal range of laboratory tests in the research center): aspartate aminotransferase (AST) \>3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \>3 times ULN, total bilirubin level (TBL) \>2 times ULN (excluding Gilbert's syndrome). Creatinine clearance \<45 mL/min (calculated by Cockcroft-Gault formula)
5. Women in pregnancy, less than 6 months after miscarriage, less than 1 year after delivery and lactation.
6. History of infectious diseases including but not limited to hepatitis A, hepatitis B, hepatitis C, HIV and syphilis
7. Presence of known hemoglobin-related diseases, anemia (moderate to severe) or other known hemoglobin diseases that interfere with HbA1c measurement (such as sickle cell disease). Presence of massive albuminuria (urinary protein excretion rate \>300 mg/g) or past medical history.
8. Presence of severe heart disease or cardiovascular disease within 6 months before screening, including: stroke, decompensated heart failure (NYHA class III or IV), myocardial infarction, unstable angina, those who have undergone coronary artery bypass grafting.
9. History of coagulation disorders or need for long-term anticoagulation treatment (such as warfarin) (low-dose aspirin treatment is allowed) or INR\>1.5
10. Treatment (local, intra-articular, intraocular, or inhaled formulations) for any other factors or diseases, other than the above reasons, that the researcher deems unsuitable for participation in this clinical study.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang University Second Affiliated Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Sheng Yan, PhD, MD — Zhejiang University Second Affiliated Hospital
• Study coordinator: Xi Ma, MD

Conditions: T3c Diabetes