Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hospital San Carlos, Madrid
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
2. ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
3. Patients with hepatic metastases of colorectal carcinoma and insufficient hepatic remnant function to perform a major hepatectomy. This volume would be calculated by Positron emission tomography-Computed tomography (PET-CT) images or 64-channel multidetector CT.
In patients who have received preoperative chemotherapy, the estimate residual liver volume to be included in the study will be \<40%.
Patients who have preserved liver function (Child ≤ B7 and International Normalized Ratio (INR) ≤ 2 in non-anticoagulated patients) and those who have not received chemotherapy, needs \< 30% of residual volume to be included in the study.
4. Patients should have signed informed consent.
You may not be if
1. Pregnancy or lactation period.
2. Any condition that the investigators consider an unjustifiable risk in the patient.
3. Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
4. Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
5. Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
6. Patients who have not received research drugs in the last 30 days or in the period of 5 elimination half-life.
7. In patients on chemotherapy treatment, G-CSF can not be administered until 48 hours after the last administration of chemotherapy. Patients who have received Bevacizumab must wait 30 days since the last administration.
8. In addition, all those aspects that prevent the patient from being part of the study, understand the rules, follow the instructions given, or other aspects.
Clareo Health | Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
