Phase II clinical trial to evaluate the efficacy and safety in the use of pancreatic islets cells from cadaver donors for the treatment of Type-I Diabetes Mellitus in renal transplant patients.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004523-19-ES

Enrollment

Registered

2010-03-15

Start date

2008-02-08

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Type-I Diabetes Mellitus in renal trasplant patients MedDRA version: 8.1 Level: pt Classification code 10061835

Interventions

Product Name: Pancreatic islets cells in suspension from cadaver donor Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: . Type-I diabetes mellitus patients with renal transplantation and good renal function (serum creatinine 40 ml/min and proteinuria =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: . Deliberate desire not to take part in the trial. . Negative to sign the informed consent, essetial to take part in the Trial. . Presence of higher cardiovascular risks: ischemic cardiopathy, peripheral vasculopathy (amputation and/or intermittent claudication) and left ventricular dysfunction (LVEF left ventricular ejection fraction 0.7 U/kg/day. . HbA1c > 12%. . Uncontrolled hyperlipidemia. . Obesity. . Any other medical situation which in the investigator’s opinion could interfere with optimum participation in the trial or cause significant risk for the patient.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of the pancreatic islet cells transplantation from a cadaver donor, in the glycemic control of patients with Type-I Diabetes Mellitus and renal transplant, through its implantation into the liver by percutaneous portal vein catheterization. ;Secondary Objective: To evaluate "the dose of pancreatic islet cells" in the use of such therapy.;Primary end point(s): . Proportion of patients who get the control of gylcemic levels without the administration of any exogenous insulin in the post-transplant period, in Type-I diabetes mellitus patients with renal transplantation. . Correlation between pre-trasplant and post-transplant blood glucose levels, and the control of insulin secretion in response to blood glucose after pancreatic islets transplant.	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of the pancreatic islet cells transplantation from a cadaver donor, in the glycemic control of patients with Type-I Diabetes Mellitus and renal transplant, through its implantation into the liver by percutaneous portal vein catheterization. ;Secondary Objective: To evaluate "the dose of pancreatic islet cells" in the use of such therapy.;Primary end point(s): . Proportion of patients who get the control of gylcemic levels without the administration of any exogenous insulin in the post-transplant period, in Type-I diabetes mellitus patients with renal transplantation. . Correlation between pre-trasplant and post-transplant blood glucose levels, and the control of insulin secretion in response to blood glucose after pancreatic islets transplant.

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Countries

Spain

Outcome results

None listed

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