Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: CD133+ infusion; Other: portal vein embolization

• Registration Number: NCT03803241
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-05-31
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVE + CD133	CD133+ infusion	preop portal vein embolization + stem cells infusion
PVE + CD133	portal vein embolization	preop portal vein embolization + stem cells infusion
PVE	portal vein embolization	only preop portal vein embolization

Primary Outcome Measures

Name	Time	Method
Liver volume	once residual liver volume reach >40%, an average of 5 weeks.	Liver volume estimated by computed tomography

Secondary Outcome Measures

Name	Time	Method
Liver volume	Post-surgery follow-up visits the first 24 months	Liver volume estimated by computed tomography

Trial Locations

Locations (2)

Alejandra Garcia Botella; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain