Diabetes After Total PancreatectomyPhase 2NCT05990517
Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients
A Phase 2 study testing YD01-2022 in people with Diabetes After Total Pancreatectomy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of autologous transplantation of expanded pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes After Total Pancreatectomy
- What is being tested?
- YD01-2022
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Voluntarily sign an informed consent form and comply with the trial treatment plan and visit schedule.
- 2. Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
- 3. Diagnosed with chronic pancreatitis and indication for total pancreatectomy. 4. Post-total pancreatectomy, experiencing elevated blood glucose levels and meeting the diagnostic criteria for diabetes (World Health Organization, 2019 edition).
- 5. Post-mixed meal stimulation, C-peptide level <0.3 ng/mL at 120 minutes. 6. Sexually active males who are not surgically sterilized or have partners of childbearing potential agree to use effective contraception during the entire trial period and for at least 6 months after the study ends; sexually active females of childbearing potential agree to use effective contraception during the entire study period and for at least 6 months after the study ends.
- History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic criteria for diabetes.
- Previous pancreatic or islet transplantation.
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- Uncontrolled hypertension, such as systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg despite stable dose (at least 4 weeks) of antihypertensive medication.
- Known hemoglobin-related diseases, anemia (moderate to severe), or other known hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell disease).
- Impaired liver or kidney function at screening (reference range from the study center's laboratory): 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 rate <45 mL/min (calculated by the Cockcroft-Gault formula).
- Significant albuminuria (urinary albumin excretion rate >300 mg/g) or history thereof.
- Uncontrolled thyroid disease or adrenal insufficiency.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA ≥104 copies or ≥2000 IU/mL (HBsAg positive with HBV DNA <2000 IU/mL (<104/mL) must receive antiviral treatment throughout the study; HBcAb positive with HBV DNA <2000 IU/mL (<104/mL) require regular monitoring of HBV DNA quantification throughout the study); Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA ≥103 IU/mL; Human immunodeficiency virus (HIV) antibody positive; Active syphilis infection (cured cases may be included); Cytomegalovirus (CMV) DNA positive; Positive nucleic acid test for novel coronavirus (COVID-19).
- Severe heart disease or a history of cardiovascular disease within 6 months before screening, including stroke, decompensated heart failure (NYHA class III or IV), myocardial infarction, unstable angina, or coronary artery bypass grafting.
- Previous history of coagulation disorders or requiring long-term anticoagulant therapy (e.g., warfarin) (low-dose aspirin therapy is allowed) or patients with INR >1.5.
- Substance abusers with a history of drug abuse/dependence or drug use within 1 year before screening.
- Received live virus vaccines within the past 6 months or planned to receive live virus vaccines during the trial or within 1 month after treatment. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guérin, typhoid vaccine, COVID-19 vaccine, etc.
- Previous history of pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, end-stage lung disease, or liver cirrhosis.
- Other abnormal laboratory test results deemed clinically significant by the investigator.
- Patients with severe mental illness.
- Participated in a drug or medical device clinical trial within the past 3 months and received investigational drugs or medical devices; or within 5 half-lives of another drug before screening (if the half-life exceeds 3 months).
- Currently receiving long-term (continuous for ≥14 days) systemic pharmacological doses of glucocorticoids or other medications that may affect the participant's consciousness.
- Treatment (local, intra-articular, intraocular, or inhalation preparations) for any other factors or diseases not mentioned above, deemed unsuitable for participation in this clinical study by the investigator.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
Shanghai, 200025
Weiqiong Gu, PhD, 86-21-64370045 ext. 672701, Gwq10978@rjh.com.cn
About this study
Official title: Evaluation of the Efficacy and Safety of Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients With Diabetes Mellitus After Total Pancreatectomy
This study will evaluate the efficacy and safety of autologous transplantation of expanded pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy.
- Conditions
- Diabetes After Total Pancreatectomy
- Being tested
- YD01-2022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YD01-2022Biological
Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein.
| Study group | Role | What they receive |
|---|---|---|
| YD01-2022 | Experimental | Not described Receives: Biological: YD01-2022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide change
Evaluation of the magnitude of C-peptide change after transplantation
Measured: 12 months post-transplant
Secondary outcomes (6)
the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events
Measured: 52 weeks post-transplant
The proportion of subjects who are insulin-independent
Measured: 12 weeks and 52 weeks post-transplant
The percentage reduction in insulin requirement
Measured: 12 weeks and 52 weeks post-transplant
Glycemic control (MAGE)
Evaluation of the average amplitude of glycemic fluctuations (MAGE) in subjects
Measured: 12 weeks and 52 weeks post-transplant
Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)
Measured: baseline and 52 weeks post-transplant
Quality of life score
Evaluation of the quality of life score in subjects
Measured: baseline and 52 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Feb 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes After Total PancreatectomyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990517
- Sponsor's protocol ID
- YD01-2022
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients With Diabetes Mellitus After Total Pancreatectomy
- ClinicalTrials.gov ID
- NCT05990517
- Acronym / sponsor ID
- YD01-2022
- Conditions
- Diabetes After Total Pancreatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
This study will evaluate the efficacy and safety of autologous transplantation of expanded pancreatic islet cells in patients with diabetes mellitus after total pancreatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YD01-2022 | Experimental | Biological: YD01-2022 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 1. Voluntarily sign an informed consent form and comply with the trial treatment plan and visit schedule.
- 2. Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
- 3. Diagnosed with chronic pancreatitis and indication for total pancreatectomy. 4. Post-total pancreatectomy, experiencing elevated blood glucose levels and meeting the diagnostic criteria for diabetes (World Health Organization, 2019 edition).
- 5. Post-mixed meal stimulation, C-peptide level <0.3 ng/mL at 120 minutes. 6. Sexually active males who are not surgically sterilized or have partners of childbearing potential agree to use effective contraception during the entire trial period and for at least 6 months after the study ends; sexually active females of childbearing potential agree to use effective contraception during the entire study period and for at least 6 months after the study ends.
- History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic criteria for diabetes.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| YD01-2022Human islet cells were isolated and expanded in vitro to generate islets containing all types of pancreatic endocrine cells and possessing comparable function of human islets. These islet cells will be infused into the hepatic portal vein. | Biological | YD01-2022 |
Primary outcome
C-peptide change
Time frame: 12 months post-transplant
Evaluation of the magnitude of C-peptide change after transplantation
6 secondary outcomes
the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events
Time frame: 52 weeks post-transplant
The proportion of subjects who are insulin-independent
Time frame: 12 weeks and 52 weeks post-transplant
The percentage reduction in insulin requirement
Time frame: 12 weeks and 52 weeks post-transplant
Glycemic control (MAGE)
Time frame: 12 weeks and 52 weeks post-transplant
Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)
Time frame: baseline and 52 weeks post-transplant
Quality of life score
Time frame: baseline and 52 weeks post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes After Total Pancreatectomy
RecruitingObservational study
Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients
Pancreatectomy, Diabetes Mellitus Type 2
Recruiting
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
Pancreatectomy, Total Pancreatectomy
Not yet recruitingObservational study
Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus
Diabetes Mellitus Type 2, Pancreatectomy
Enrolling by invitationObservational study
Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation
Islets of Langerhans Transplantation, Pancreatitis, Chronic
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YD01-2022 in people with Diabetes After Total Pancreatectomy, run by Shanghai Jiao Tong University School of Medicine 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 22 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiqiong Gu, PhD (86-21-64370045 ext. 671701, Gwq10978@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide change (time frame: 12 months post-transplant). 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 14 Aug 2023.