Status:
ACTIVE_NOT_RECRUITING
Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Shanghai Newislet Therapeutics Co., Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
Islet cells are isolated from resected pancreatic tissue obtained from patients undergoing surgery, followed by ex vivo expansion and culture. Subsequent procedures include HLA typing, functional asse...
Eligibility Criteria
Inclusion
- Aged ≥18 and ≤70 years at the time of informed consent, regardless of sex; History of total pancreatectomy with baseline C-peptide levels below the lower limit of normal;
- Post-pancreatectomy hyperglycemia consistent with diagnostic criteria for T3cDM;
- Stimulated C-peptide level \< 0.3 ng/mL at 120 minutes following a mixed meal;
- HbA1c≥7.5% or TIR \< 70% despite intensified insulin therapy;
- Male participants who are sexually active and not surgically sterilized or whose partners are of childbearing potential must agree to use effective contraception and refrain from sperm donation throughout the study and for at least 6 months thereafter; female participants of childbearing potential must agree to use effective contraception for the duration of the study and for at least 6 months thereafter.
- Voluntary written informed consent and willingness to comply with the study protocol and visit schedule.
Exclusion
- Known hemoglobinopathies or moderate-to-severe anemia interfering with HbA1c interpretation;
- Positive HBsAg or HBcAb with HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; Patients with positive HBsAg and HBV DNA \<2000 IU/mL must be on antiviral therapy throughout the study. Patients with positive HBcAb and HBV DNA \<2000 IU/mL must undergo regular HBV DNA monitoring;
- Positive HCV antibody with HCV RNA≥10³IU/mL;
- Positive HIV antibody testing;
- Active syphilis infection (those with resolved infection may be included);
- Existence or suspicion of other uncontrollable or untreatable fungal, bacterial, viral or other infections;
- Uncontrolled hypertension (SBP \>160 mmHg and/or DBP \>100 mmHg despite stable antihypertensive treatment for ≥4 weeks);
- History of coagulopathy or long-term anticoagulation therapy (e.g., warfarin) or INR \>1.5 (low-dose aspirin permitted);
- Impaired liver function: AST or ALT \>3× ULN Total bilirubin \>2× ULN;
- Impaired renal function with Creatinine clearance \<45 mL/min (Cockcroft-Gault formula);
- History of end-stage heart or lung disease, or cirrhosis;
- Presence or history of any type of cancer, excluding papillary thyroid cancer cured for more than 1 year;
- Severe mental/psychological disorders, or severe cognitive impairment
- Pregnant or lactating women;
- Other situations or abnormal findings judged by the investigator as unsuitable for participating in the trial.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06991829
Start Date
April 3 2025
End Date
October 31 2027
Last Update
May 28 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032