Phase 2
N=3
Allogeneic Islet Cells Transplanted Onto the Omentum
Type 1 Diabetes Mellitus · Hypoglycemia · Hypoglycemia Unawareness
Bottom Line
View on ClinicalTrials.gov: NCT02213003 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: A1c </= 6.5% and no Severe Hypoglycemia — 0.667 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Islet transplantation (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rodolfo Alejandro
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A1c </= 6.5% and no Severe Hypoglycemia |
0.667 | — |
| PRIMARY Procedural Complications |
3 | — |
Summary
Current islet transplantation into the portal vein of the liver has shown the unique ability of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the need for systemic immunosuppression to maintain function and the loss of islet function over time. Additionally, many studies have demonstrated that the current site of transplantation in the liver is not an ideal site due to several factors. These factors include (1) significant liver inflammation following islet infusion; (2) potential for life-threatening procedure-related complications such as bleeding and thrombosis; (3) high levels of immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the inability to retrieve islets after infusion; and (5) development of graft dysfunction in a number of recipients of intrahepatic allogeneic and autologous islets. The implantation of islets into the omentum will allow adequate engraftment of islets onto the omentum and will lead to comparable or superior functional and clinical outcomes than in the traditional intrahepatic site.
Eligibility Criteria
Inclusion Criteria
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Type1 diabetes with onset of disease at 5 years at the time of enrollment
- Absent stimulated c-peptide ( 30 kg/m2 or patient weight ≤50 kg.
- Insulin requirement of >1.0 IU/kg/day or 10%.
- Untreated proliferative diabetic retinopathy.
- Blood Pressure: SBP >160 mmHg or DBP >100 mmHg.
- Glomerular filtration rate 300mg/g creatinine).
- Presence or history of panel-reactive anti-HLA antibodies.
- For female subjects: Serum or urine Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control.
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB).
- Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
- Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment.
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- Active alcohol or substance abuse.
- Hb below the lower limits of normal at the local laboratory; lymphopenia ( 130 mg/dL, fasting triglycerides > 200 mg/dl).
- Chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
- Treatment with any anti-diabetic medications other than insulin within 4 weeks of enrollment.
- Use of any investigational agents within 4 weeks of enrollment. 24. Administration of live attenuated vaccine(s) within 2 months of enrollment. 25. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.
- Treatment with any immunosuppressive regimen at the time of enrollment. 27. A previous islet transplant. 28. A previous pancreas transplant 29. Inflammatory bowel disease. 30. History of intestinal obstructions. 31. Previous major abdominal surgery. 32. History of peritonitis.
Data sourced from ClinicalTrials.gov (NCT02213003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.