Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2005-004523-19-ES
EUCTR2005-004523-19-ES
Active, not recruiting
Not Applicable

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.

Área de Trasplante y Terapia Celular - Hospital Central de Asturias0 sites10 target enrollmentMarch 15, 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsType-I Diabetes Mellitus in renal trasplant patientsMedDRA version: 8.1Level: ptClassification code 10061835

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type-I Diabetes Mellitus in renal trasplant patients
Sponsor
Área de Trasplante y Terapia Celular - Hospital Central de Asturias
Enrollment
10
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 15, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Área de Trasplante y Terapia Celular - Hospital Central de Asturias

Eligibility Criteria

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

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\.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Phase III clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19.COVID-19Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2020-001760-29-ESSociedad Española de Farmacia Hospitalaria156
Active, not recruiting
Phase 1
Study to evaluate the efficacy of FOLFIRI + aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without ACE polymorphismsMetastatic colorectal cancerMedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001508-45-ESGrupo de Tratamiento de los Tumores Digestivos (TTD)100
Active, not recruiting
Phase 1
Randomised clinical trial to test if silibinin administration can prevent the respiratory failure secondary to the COVID19 lung infection in oncologic patients.COVID19 respiratory failureTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2020-001794-77-ESINSTITUT CATALÀ D'ONCOLOGIA GIRONA - HOSPITAL JOSEP TRUETA92
Active, not recruiting
Phase 1
Clinical trial to evaluate the effectiveness and safety of acetazolamide in the treatment of cerebellar syndrome in patients with phosphomannomutase deficiency.Cerebellar syndromeMedDRA version: 19.1Level: PTClassification code 10008072Term: Cerebellar syndromeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2017-000810-44-ESFundació Sant Joan de Déu30
Recruiting
Phase 2
Cladribine therapy in Myasthenia
2024-517083-32-00Uniwersytet Medyczny W Lublinie200