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NCT07118475: APPITD
Autologous Islet Transplantation for Diabetes
EARLY_PHASE1 trial testing Autologous islet transplantation in Diabetes Mellitus, Type 2 in 24 participants. Enrolling by invitation.
30 May 2027
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 7 October 2025 |
| Primary completion | 30 May 2027 |
| Estimated completion | 30 May 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Autologous islet transplantation — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to conduct an exploratory clinical trial recruiting insulin-dependent diabetic patients who meet the criteria for islet transplantation. Pancreatic tissue will be obtained via endoscopic ultrasound-guided fine-needle aspiration biopsy, and adult pancreatic progenitor cells (APP) will be expanded in vitro and differentiated into islet-like cells. After quality assessment, these cells will be transplanted via injection beneath the anterior rectus sheath. Following autologous transplantation of APP-derived islets, the transplanted islets are expected to survive at the implantation site, stably secrete insulin, and thereby reduce or potentially eliminate the need for exogenous insulin. Glycated hemoglobin (HbA1c) levels are anticipated to decrease, with a significant reduction in the risk of severe hypoglycemic episodes, and no transplant-related adverse events are expected. As this is an exploratory clinical study, participants may not benefit from APP islet transplantation and may face risks or adverse events associated with the procedure. However, the findings of this research may advance more scientific and effective treatment strategies for diabetes. The successful completion of this study could provide a feasible and scalable approach to functionally curing diabetes, effectively reducing disability and mortality rates among diabetic patients, improving their quality of life, and generating substantial health, economic, and social benefits.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07118475
- Europe PMC full search
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Related trials
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- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07118475 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 6 April 2026
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