- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415643
The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes
May 14, 2024 updated by: Sheng Yan, Zhejiang University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this clinical trial is to verify the safety and effectiveness of autologous islet transplantation after in vitro expansion in the forms of functional islet organoids, for the treatment of pancreatogenic diabetes in patients who have undergone pancreatic resection through a single-center single-arm study We aim to establish the entire operational process of isolating expanding and transplanting islets from the pancreas removed from the patient and managing postoperative care We hope to accumulate clinical experience in treating pancreatogenic diabetes with transplanted autologous islet cell clusters expanded in vitro establish standard and regulated medical operations and gather materials for future applications of this treatment method in clinical practice.
Study Type
Interventional
Enrollment (Estimated)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xi Ma, MD
- Phone Number: 86-18768117002
- Email: xima@zju.edu.cn
Study Contact Backup
- Name: Qing Cissy Yu, PhD
- Phone Number: 86-13916205952
- Email: qing.yu@newislet.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Zhejiang University Second Affiliated Hospital
-
Contact:
- Xi Ma, MD
- Phone Number: 86-18768117002
- Email: xima@zju.edu.cn
-
Principal Investigator:
- Sheng Yan, PhD,MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntarily sign the informed consent form and adhere to the trial treatment plan and visit schedule.
- When signing the informed consent form, the age should be between 18-70 years old, with no gender restrictions.
- 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.
- 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.
- Clinical examinations must meet the following criteria: Normal glycated hemoglobin (HbA1c) measurement.
- Normal alanine aminotransferase (ALT) measurement, or abnormal but clinically insignificant
- 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.
- 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.
- Post-pancreatic surgery blood sugar increase, meeting the diagnostic criteria for diabetes (World Health Organization 2019 edition).
- C-peptide level <0.3 ng/mL 120 minutes after mixed meal stimulation before pancreatic islet transplantation.
Exclusion Criteria:
- The investigator considers the following diseases to be clinically significant: a history of diabetes, or preoperative hyperglycemia, meeting the diagnosis of diabetes.
- Undergone previous pancreatic or islet transplantation
- 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.
- 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)
- Women in pregnancy, less than 6 months after miscarriage, less than 1 year after delivery and lactation.
- History of infectious diseases including but not limited to hepatitis A, hepatitis B, hepatitis C, HIV and syphilis
- 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.
- 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.
- History of coagulation disorders or need for long-term anticoagulation treatment (such as warfarin) (low-dose aspirin treatment is allowed) or INR>1.5
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transplantation group
transplantation group
|
autologous transplantation of ex vivo expanded islet organoids.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-peptide secretion
Time Frame: before transplantation and 1 year after transplantation
|
C-peptide detection assay
|
before transplantation and 1 year after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c level
Time Frame: before transplantation and 1 year after transplantation
|
HbA1c detection assay
|
before transplantation and 1 year after transplantation
|
MAGE
Time Frame: 12 weeks and 52 weeks post transplantation
|
Glucose measurement
|
12 weeks and 52 weeks post transplantation
|
Ryan Hypoglycemia event
Time Frame: baseline and 52 weeks post transplantation
|
recorded events of severe hypoglycemia
|
baseline and 52 weeks post transplantation
|
Insulin usage
Time Frame: 12 weeks and 52 weeks post transplantation
|
comparison of Insulin usage
|
12 weeks and 52 weeks post transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheng Yan, PhD, MD, Zhejiang University Second Affiliated Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 10, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
May 9, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YD-ZE-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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