CD133 + CELL INFUSION IN PATIENTS WITH COLORECTAL LIVER ORIGIN METASTASES GOING TO BE SUBMITTED TO A MAJOR LIVER RESECTIO

Phase 1

• Conditions: patients with liver metastases from colorectal carcinoma; MedDRA version: 17.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001402-18-ES
• Lead Sponsor: ALEJANDRA GARCIA BOTELLA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-16
• Study Completion: 2020-12-31
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Age between 18 and ? 80 years old
2. Quality of Life Scale ECOG (Eastern Cooperative Oncology Group) ?2
3. Potential childbearing women must follow contraception methods recomended by Clinical Trial Facilitation Group (CTFG) .
4. patients with liver metastases from colorectal carcinoma, which have insufficient liver remnant to make a major hepatectomy. This volume is calculated by imaging with multidetector CT of 64 channels.
- patients who received preoperative chemotherapy and estimated residual liver volume <40%.
- Patients with preserved liver function who have not received chemotherapy and calculated residual volume <30%
5. Signing the informed consent.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Any condition that, according to the researchers, involving subjecting the patient to an unjustifiable risk.
3. Severe comorbidities: ASA ? 4.
4. Changes in the blood count and morphological alterations, hematologist accounted for prior to the administration of G-CSF.
5. Liver function: Child ? B7, INR ? 2 in anticoagulated patients, in patients anticoagulated values prior to the surgery reversed.
6. Participation in other research studies in the last 12 months.
7. Patients on chemotherapy, can not be administered G-CSF until they have not spent 48 hours after the last dose of chemotherapy. Patients who received Avastin must wait 30 days from the last administration.
8. Aspects that prevent the patient cannot be part of the study such as understanding the rules thereof, follow the instructions to be given, or other aspects deemed appropriate.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effectiveness of preoperative portal embolization with administration of single liver CD133 + cells mobilized with G-CSF compared to portal embolization;Secondary Objective: Evaluate the Safety of experimental treatment<br>Compare final degree of hypertrophy after surgery and how the biochemical parameters of liver function are modified in both groups.<br>Assessment of different morphological changes that occur in the same following administration of G-CSF<br>Compare the postoperative morbidity between groups. <br>Analyze the event-free survival (death from any cause) in groups.;Primary end point(s): Liver volumes (in cubic centimeters, cc);Timepoint(s) of evaluation of this end point: Before surgery, after embolization site after surgery. <br>The first control after PVE was performed at 2 weeks and repeated every 2 weeks until surgery. <br>After surgery monthly until month 24 (1,3,6,12,18,24).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events related to infusion of CD133 + cells. <br>Analytical Parameters: Total bilirubin, albumin, AST, ALT, alkaline phosphatase, GGT, WBC, hemoglobin, hematocrit, platelets, INR, prothrombin activity and clinical parameters: presence or absence of ascites and / or hepatic encephalopathy. <br>Morphological changes of the liver <br>Postoperative morbidity. <br>Death from any cause.;Timepoint(s) of evaluation of this end point: Antes de la cirugía, tras la embolización portal y después de la cirugía.<br>El primer control tras la PVE se realizará a las 2 semanas y se repetirá cada 2 semanas hasta cirugía.<br>Tras la cirugía mensualmente hasta mes 24 (1,3,6,12,18,24).