CD133+ infusion
DrugInfusion of cells cd133+
NCT Number: NCT03803241
Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient remnant liver volume (RLV), which allows maintaining optimal liver function after resection. If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still, in 20% of these patients surgery can not be performed because RLV is not achieved or because the disease progresses while waiting for growth. Therefore, it is necessary to improve liver regeneration without promoting tumor growth. Studies on liver regeneration, have determined that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy. CD133 + have been used to induce liver hypertrophy with encouraging results. This population of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte colony-stimulating factor (G-CSF), being able to obtain a large number of them. The investigators propose to treat patients who do not meet criteria for surgery because of insufficient volume <40%, with CD133 + and portal embolization in order to carry out a surgical resection in a second place.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Alejandra Garcia Botella, Madrid, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Infusion of cells cd133+
portal vein embolization
Time frame: once residual liver volume reach >40%, an average of 5 weeks.
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 30 days
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 90 days
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 180 days
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 12 months
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 18 months
Liver volume estimated by computed tomography
Time frame: Post-surgery follow-up visits the first 24 months
Liver volume estimated by computed tomography
Hospital San Carlos, Madrid
Other
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
Acronym: cellcol
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT07725692
Anastomotic Leak, Colon Cancer
Alexandria, Please Select, Egypt
View Trial DetailsNCT07180303
Colonic Diseases, Colorectal Cancer
Liyang, Jiangsu, China
View Trial DetailsNCT03958747
Colonic Diseases, Colorectal Cancer
Winston-Salem, North Carolina, United States
View Trial Details