T3c DiabetesNCT06415643
The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes
A study testing Islet organoids transplantation in people with T3c Diabetes, run by Zhejiang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T3c Diabetes
- What is being tested?
- Islet organoids transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang University Second Affiliated Hospital
Hangzhou, Zhejiang
Xi Ma, MD, 86-18768117002, xima@zju.edu.cn
Sheng Yan, PhD,MD
About this study
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.
Read the 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 participants who have undergone pancreatic resection through a single-center single-arm study. The investigators aim to establish the entire operational process of isolating expanding and transplanting islets from the pancreas removed from the participants and managing postoperative care. The investigators 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.
- Conditions
- T3c Diabetes
- Being tested
- Islet organoids transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islet organoids transplantationOther
autologous transplantation of ex vivo expanded islet organoids.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation group | Experimental | transplantation group Receives: Other: Islet organoids transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide secretion
C-peptide detection assay
Measured: before transplantation and 1 year after transplantation
Secondary outcomes (4)
HbA1c level
HbA1c detection assay
Measured: before transplantation and 1 year after transplantation
Mean Amplitude of Glycemic Excursion (MAGE)
Glucose measurement
Measured: 12 weeks and 52 weeks post transplantation
Ryan Hypoglycemia event
recorded events of unaware severe hypoglycemia (glucose level below 3 mmol/L)
Measured: baseline and 52 weeks post transplantation
Reduced Insulin usage
Reduced insulin usage of over 50% compared with prior to treatment
Measured: 12 weeks and 52 weeks post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Aug 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T3c DiabetesStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Newislet Biotechnology (Shanghai) Ltd.
- Responsible party
- Principal investigator, Sheng Yan, Zhejiang University
- Investigators
- Sheng Yan, PhD, MD, Principal investigator, Zhejiang University Second Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415643
- Sponsor's protocol ID
- YD-ZE-001
- Status last verified
- Jul 2024
- First submitted
- 9 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Islet Organoids in the Treatment of Pancreatic Surgery-related Diabetes
- ClinicalTrials.gov ID
- NCT06415643
- Acronym / sponsor ID
- YD-ZE-001
- Conditions
- T3c Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Newislet Biotechnology (Shanghai) Ltd.
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 participants who have undergone pancreatic resection through a single-center single-arm study. The investigators aim to establish the entire operational process of isolating expanding and transplanting islets from the pancreas removed from the participants and managing postoperative care. The investigators 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation group | Experimental | Other: Islet organoids transplantationtransplantation group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Islet organoids transplantationautologous transplantation of ex vivo expanded islet organoids. | Other | Transplantation group |
Primary outcome
C-peptide secretion
Time frame: before transplantation and 1 year after transplantation
C-peptide detection assay
4 secondary outcomes
HbA1c level
Time frame: before transplantation and 1 year after transplantation
Mean Amplitude of Glycemic Excursion (MAGE)
Time frame: 12 weeks and 52 weeks post transplantation
Ryan Hypoglycemia event
Time frame: baseline and 52 weeks post transplantation
Reduced Insulin usage
Time frame: 12 weeks and 52 weeks post transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Yan, PhD, MD principal investigator
Zhejiang University Second Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Islet organoids transplantation in people with T3c Diabetes, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Ma, MD (86-18768117002, xima@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide secretion (time frame: before transplantation and 1 year after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.