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.

• Conditions: Type-I Diabetes Mellitus in renal trasplant patients; MedDRA version: 8.1Level: ptClassification code 10061835

• Registration Number: EUCTR2005-004523-19-ES
• Lead Sponsor: Área de Trasplante y Terapia Celular - Hospital Central de Asturias

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

. Type-I diabetes mellitus patients with renal transplantation and good renal function (serum creatinine < 2 mg/dl, creatinine clearance > 40 ml/min and proteinuria < 1 gr/day).
. Patients who were indicated a renal but not a pancreas transplantation because of the high-risk for surgery. For these patients renal and pancreatic islet cells transplant will be performed at the same time.
. Patients between 18 and 65 years of age.
. C-peptide levels < 0.48 ng/ml.
. Body Mass Index (BMI) < 28 kg/m2
. Time of renal transplantantion of at least 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 <30%).
. Consumption of alcohol or any other substance abuse, including tobacco (abstinence is required for a period of at least 6 months).
. Active infections (hepatitis B and C, HIV, tuberculosis, etc.).
. Presence of neoplasia within 5 years prior to the transplantation, excluding nonmelanoma skin carcinomas.
. Hepatic disease or hepatic disorders (ie. portal hypertension detected by ecographic control).
. Presence of motor neuropathy or autonomic impairment.
. Presence of coagulation disorders.
. Presence of Leukopenia <3000/mm3 or thrombopenia <100.000/mm3.
. Renal failure (creatinine clearance <60 ml/min or macroalbuminuria), except when performed together with the renal transplant.
. Non-treated proliferative retinopathy .
. Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods.
. Daily insulin requirement > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br><br>. 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.