The use of stem cells to assist in regenerating the liver before cancerous parts of the liver are removed

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: 1. Control group: right hepatic portal embolization 2. Study group: right hepatic portal embolization plus infusion of stem cells. Generic drug name: mononuclear bone marrow stem cells 3. Dosage given: 2.000 x 106 cells 4. Method and frequency of administration: intraportal infusion in a single administration 5. Follow up for all treatment arms: 12 months CONDITION: Use of stem cells in hepatic resection due to hepatic space occupying lesions ; Cancer ; Malignant neoplasm of liver PRIMARY OUTCOME: 1. Adverse events and serious adverse events in the first 24 hours of administering the BM‐MNCs, and observed in the follow ups at 2, 4 and 6 weeks following cell therapy administration; 2. Assessment of the hepatic volume via computed tomography (CT) (10 mm thick axial helical CT with 10 mm reconstruction) at 2, 4 and 6 weeks following the administration of cell therapy (until 8 weeks in cyrrhotic patients):; 2.1. In each axial section: volume (cm3) = Area (cm2) x reconstruction index (cm); 2.2. The volumes are calculated by totalling the areas of each cut; 3. The following parameters are used:; 3.1. Total hepatic volume (THV); 3.2. Residual hepatic volume (RHV); 3.3. Percentage THV / RHV SECONDARY OUTCOME: 1. Duration of hepatic regeneration (days); 2. Percentage of patients that can be fully operated on; 3. Time since [falling ill]; 4. Assessment of the hepatic regeneration response:; 4.1. TNF‐a, interleukina 2, interleukina 6; 4.2. Hepatocyte Growth Factor (HGF); 4.3. Epidermal Growth Factor (EGF); 4.4. Transforming Growth Factor Alpha (TGF‐a); 4.5. Insulinaemia; 4.6. Metanephrines (urine); 5. Inherent post‐operative complications regarding the residual hepatic volume (degree of liver failure: Model fo End stage Liver Disease ‐ MELD); 6. Resection margins free from tumours; 7. Structured histological assessment of the regenerated hepatic tissue and of the degree of fibrosis INCLUSION CRITERIA: 1. Patients of both sexes aged between 18 and 70 2. Normal analytical parameters, defined by: 2.1. Leukocytes higher than 3,000 2.2. Neutrophils higher than 1,500 2.3. Platelets higher than 100,000 2.4. AST/ALT less than 1.5 standard institutional range 2.5. Creatinine less than 1.5 mg/dl 3. Patients with a hepatic space occupying lesion (SOL) which need an extended hepatic resection (of more than five segments) 4. The selection must be careful and basically include 4 types of hepatic lesions which must previously be submitted to a hepatic volumetry: 4.1. Metastatic disease susceptible to extended right hepatectomy in segment IV 4.2. Metastatic disease susceptible to right hepatectomy with suspected liver disease(neoadjuvant chemotherapy) (when hepatic function is unclear, the indocyanine green test can be used) 4.3. Bilobar hepatic metastases with multiple nodules in the right lobe, and more than 3 nodules bigger than 30mm in the l
Epistemonikos ID: 831235b1d50ce15328da658388757928871e5839
First added on: Aug 22, 2024