Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank … (NCT06991829) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Clinical Study on the Safety and Efficacy of Immunophenotyped Pancreatic Endocrine Organoid Bank in Treating Patients With T3c Diabetes
China29 participantsStarted 2025-04-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Known hemoglobinopathies or moderate-to-severe anemia interfering with HbA1c interpretation;
What they're measuring
1
Proportion of Participants with ≥50% Reduction in Daily Insulin Dose at Week 52 Post-Transplantation Compared to Baseline
Timeframe: From enrollment to the end of treatment at 52 weeks post-transplantation
2
Proportion of Participants with HbA1c < 7.0% at Week 52 Post-Transplantation
Timeframe: From enrollment to the end of treatment at 52 weeks post-transplantation
3
Number of Participants with No Episodes of Severe Hypoglycemia Between Weeks 12 and 52 Post-Transplantation
Timeframe: From Week 12 to Week 52 post-transplantation
. 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;