Status:
UNKNOWN
Allogeneic Transplantation of Expanded Pancreatic Islet Cells
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Brittle Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of allogeneic pancreatic islet cells transplantation in patients with "brittle" type 1 diabetes.
Eligibility Criteria
Inclusion
- Voluntarily sign an informed consent form and agree to 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.
- Body mass index (BMI) ≥18.0 kg/m2 and ≤35.0 kg/m2.
- Diagnosed with T1DM based on the World Health Organization's diabetes classification (2019).
- HbA1c ≥7.0% and ≤15.0% at screening.
- Dependence on insulin injection therapy for ≥5 years, receiving a stable insulin treatment plan for ≥3 months, and injecting insulin three or more times per day or using an insulin pump.
- Postprandial mixed meal stimulated C-peptide level \<0.3 ng/mL.
- Experienced impaired awareness of hypoglycemia or significant glycemic instability during screening and in the past 6 months. Hypoglycemic episodes are associated with impaired awareness of hypoglycemia, extreme glycemic instability, or severe fear and maladaptive behavior.
- 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.
Exclusion
- Types of diabetes other than T1DM.
- Body mass index (BMI) \>35 kg/m2 or weight \<50 kg.
- Excessive insulin sensitivity and/or insulin resistance (insulin requirement \>1.0 IU/kg/day or \<15 U/day).
- Previous pancreatic or islet transplantation. Severe trauma, severe infection, or surgery that may affect glycemic control within one month before screening.
- History of hypertension with systolic blood pressure (SBP) \>160 mmHg and/or diastolic blood pressure (DBP) \>100 mmHg after stable dose (at least 4 weeks) of antihypertensive medication.
- Blood transfusion or severe bleeding within the past 3 months, 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: 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 or untreated thyroid disease or adrenal insufficiency.
- Severe diabetic kidney disease or renal insufficiency, proliferative retinopathy, diabetic foot ulcers, diabetes-related amputation, and/or severe peripheral neuropathy at screening.
- Active hepatitis B, hepatitis C, acquired immunodeficiency syndrome, syphilis, or tuberculosis. Even without clinical evidence of active infection, participants with laboratory evidence of active infection are also excluded.
- 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 vaccines within 14 days before screening or planned to receive live 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.
- Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors for pancreatitis, or patients with blood amylase \>1.2 times ULN at screening.
- 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.
Key Trial Info
Start Date :
February 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05990530
Start Date
February 22 2023
End Date
August 1 2025
Last Update
August 14 2023
Active Locations (1)
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1
Department of Endocrinology and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao-Tong University
Shanghai, China, 200025