Actively Recruiting
The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes
Led by Zhejiang University · Updated on 2024-07-30
5
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
N
Newislet Biotechnology (Shanghai) Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to verify the safety and effectiveness of autologous islet organoids transplantation after in vitro expansion for the treatment of pancreatogenic diabetes.
CONDITIONS
Official Title
The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and adhere to the trial treatment plan and visit schedule.
- Be between 18 and 70 years old with no gender restrictions.
- Be in good overall health with no damage to major organs such as heart, lungs, liver, or kidneys.
- Have a diagnosis of pancreatic tumor, chronic pancreatitis with diffuse pancreatic duct stones and refractory pain, pancreatic trauma, postoperative pancreatic fistula class C, or pancreatic cystic fibrosis.
- Have indications for total or subtotal pancreatectomy and no chronic organ failure.
- Have normal glycated hemoglobin (HbA1c) measurement.
- Have normal or clinically insignificant abnormal alanine aminotransferase (ALT) measurements.
- Test negative for hepatitis A, B, C, HIV, syphilis, Epstein-Barr virus, cytomegalovirus, B19 virus, and human T-lymphotropic virus.
- Male participants who are sexually active and not surgically sterilized or females capable of childbearing agree to use effective contraception during the study and for 6 months after.
- Have post-pancreatic surgery blood sugar increase meeting the 2019 WHO diabetes diagnostic criteria.
- Have C-peptide level below 0.3 ng/mL 120 minutes after mixed meal stimulation before transplantation.
You will not qualify if you...
- History of diabetes or preoperative hyperglycemia meeting diabetes diagnosis.
- Previous pancreatic or islet transplantation.
- Uncontrolled hypertension with systolic blood pressure over 160 mmHg or diastolic over 100 mmHg despite stable antihypertensive treatment.
- Fatty hepatitis, portal vein thrombosis, portal hypertension, anterolateral pancreatic jejunostomy, or visceral hyperalgesia.
- Impaired liver or kidney function beyond defined limits, including elevated liver enzymes or low creatinine clearance below 45 mL/min.
- Women who are pregnant, less than 6 months postpartum after miscarriage, less than 1 year postpartum after delivery, or currently breastfeeding.
- History of infectious diseases such as hepatitis A, B, C, HIV, or syphilis.
- Known hemoglobin-related diseases or anemia interfering with HbA1c measurement.
- Severe heart or cardiovascular disease within 6 months before screening including stroke, decompensated heart failure, myocardial infarction, or unstable angina.
- History of coagulation disorders or need for long-term anticoagulation treatment (except low-dose aspirin).
- Treatment for other medical conditions deemed unsuitable by the investigator for study participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang University Second Affiliated Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
X
Xi Ma, MD
CONTACT
Q
Qing Cissy Yu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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