Transplantation of immunoprotected pancreatic islets for the therapy of type 1 diabetes mellitus (T1DM)

Microencapsulated pancreatic islet allografts into nonimmunosuppressed patients with type 1 diabetes mellitus: a phase I single-arm single-centre pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43557935

Enrollment

Registered

2009-06-30

Start date

2004-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Graft of human pancreatic islet containing microcapsules made of alginic acid and poly-L-ornithine. Upon an overnight insulin feed-back, in order to achieve and sustain normoglycemia, the patients und

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male patients, age range: 20-50 years 2. Patients with long-standing T1DM (over 15 years) 3. On daily quadruple insulin injection therapy regimen 4. No major complications of the disease (pre-proliferative retinopathy, initial microalbuminuria, macrovascular disease)

Exclusion criteria

Exclusion criteria: 1. Female patients (because the capsules were to be implanted intraperitoneally, with possible adverse effects on ovary's function) 2. Patients with advanced complcations of T1DM 3. Patients with neoplasms whatsoever

Design outcomes

Primary

Measure	Time frame
1. Blood glucose (by reflectometer)hourly the first 7 days, thereafter 4 times a day as per usual clinical protocols for diabetes care 2. Serum C-peptide (radioimmunoassay) hourly the first 7 days, thereafter once a week in basal and 30 min after meal, throughout 2 years 3. Abdominal CT scan (1-6 months)	—

Secondary

Measure	Time frame
1. Blood glucose levels. Timepionts: hourly during the first 72 hours post-transplant, thereafter 6 times a day until 2 years post-transplantation (end of protocol) 2. Serum C-peptide. Timepoints: hourly during the first 72 hours and thereafter twice a day until 2 weeks post-transplantation (basal, 60 min after breakfast), thereafter once a day (60 min after breakfast) for 3 months, thereafter once monthly (basal + 60 min after breakfast) for 2 years 3. Depending upon obtained blood glucose control (and insulin/C-peptide output) exogenous insulin may be tapered down until suspension if necessary 4. CT scan of the abdomen every 6 months for 2 years 5. The following will be checked regularly until 2 years post-transplantation in order to assess any eventual favourable impact of the encapsulated islet grafts on secondary complications of T1DM: 5.1. Retinography 5.2. Nerve motor and sensorial conduction velocity 5.3. Microalbuminuria (24 hour urines)	—

Measure

Time frame

1. Blood glucose levels. Timepionts: hourly during the first 72 hours post-transplant, thereafter 6 times a day until 2 years post-transplantation (end of protocol) 2. Serum C-peptide. Timepoints: hourly during the first 72 hours and thereafter twice a day until 2 weeks post-transplantation (basal, 60 min after breakfast), thereafter once a day (60 min after breakfast) for 3 months, thereafter once monthly (basal + 60 min after breakfast) for 2 years 3. Depending upon obtained blood glucose control (and insulin/C-peptide output) exogenous insulin may be tapered down until suspension if necessary 4. CT scan of the abdomen every 6 months for 2 years 5. The following will be checked regularly until 2 years post-transplantation in order to assess any eventual favourable impact of the encapsulated islet grafts on secondary complications of T1DM: 5.1. Retinography 5.2. Nerve motor and sensorial conduction velocity 5.3. Microalbuminuria (24 hour urines)

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026