Loading clinical trials...

Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGEARLY_PHASE1

Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes

NCT06991829•Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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 assessment of organoid-like structures, and biobanking. After matching for HLA, the cells are administered into patients with type 3c diabetes mellitus (T3cDM) via ultrasound-guided percutaneous transhepatic portal vein catheterization. A 52-week follow-up is conducted to evaluate the safety of the cell therapy and its clinical efficacy in glycemic control.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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;
•2. Post-pancreatectomy hyperglycemia consistent with diagnostic criteria for T3cDM;
•3. Stimulated C-peptide level \< 0.3 ng/mL at 120 minutes following a mixed meal;
•4. HbA1c≥7.5% or TIR \< 70% despite intensified insulin therapy;
•5. 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.
•6. Voluntary written informed consent and willingness to comply with the study protocol and visit schedule.

Exclusion Criteria

•1. Known hemoglobinopathies or moderate-to-severe anemia interfering with HbA1c interpretation;
•2. 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;
•3. Positive HCV antibody with HCV RNA≥10³IU/mL;
•4. Positive HIV antibody testing;
•5. Active syphilis infection (those with resolved infection may be included);
•6. Existence or suspicion of other uncontrollable or untreatable fungal, bacterial, viral or other infections;
•7. Uncontrolled hypertension (SBP \>160 mmHg and/or DBP \>100 mmHg despite stable antihypertensive treatment for ≥4 weeks);
•8. History of coagulopathy or long-term anticoagulation therapy (e.g., warfarin) or INR \>1.5 (low-dose aspirin permitted);
•9. Impaired liver function: AST or ALT \>3× ULN Total bilirubin \>2× ULN;
•10. Impaired renal function with Creatinine clearance \<45 mL/min (Cockcroft-Gault formula);
+5 more criteria

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 3, 2025

Primary Completion Date

April 3, 2027

Completion Date

October 31, 2027

Last Updated

May 28, 2025

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus

Interventions

HLA-matched pancreatic endocrine organoids transplantation

PROCEDURE

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Achieving Routine Intervention and Screening for Emotional Health