Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients

NCT05990517 | Unknown Phase 2

• 1 other identifier: YD01-2022
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes After Total Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• C-peptide change

  Evaluation of the magnitude of C-peptide change after transplantation

  12 months post-transplant

Secondary Outcomes (6)

• the proportion of subjects with HbA1c ≤7.0% and no severe hypoglycemic events

  52 weeks post-transplant

• The proportion of subjects who are insulin-independent

  12 weeks and 52 weeks post-transplant

• The percentage reduction in insulin requirement

  12 weeks and 52 weeks post-transplant

• Glycemic control (MAGE)

  12 weeks and 52 weeks post-transplant

• Evaluation of the severity of hypoglycemia using the Ryan Hypoglycemia Severity Score (HYPO)

  baseline and 52 weeks post-transplant

Study Arms (1)

YD01-2022

EXPERIMENTAL

Biological: YD01-2022

Interventions

YD01-2022 BIOLOGICAL

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.

YD01-2022

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Voluntarily sign an informed consent form and comply with the trial treatment plan and visit schedule.
• \. Age ≥18 years and ≤60 years on the day of signing the informed consent form, regardless of gender.
• \. 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).
• \. 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.
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University

Shanghai, 200025, China

RECRUITING

Central Study Contacts

Weiqiong Gu, PhD

CONTACT

86-21-64370045; Gwq10978@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: February 22, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CN (1)