Back to resultsCd133+ Cell Infusion in Patients With Colorectal Liver Metastases. (cellcol)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
CD133+ infusion
portal vein embolization
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion criteria:
- Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
- ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
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.
- Patients should have signed informed consent.
Exclusion criteria:
- Pregnancy or lactation period.
- Any condition that the investigators consider an unjustifiable risk in the patient.
- Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
- Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
- Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
- Patients who have not received research drugs in the last 30 days or in the period of 5 elimination half-life.
- 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.
- 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.
Sites / Locations
- Hospital Clinico San Carlos
- Alejandra Garcia Botella
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
PVE + CD133
PVE
Arm Description
preop portal vein embolization + stem cells infusion
only preop portal vein embolization
Outcomes
Primary Outcome Measures
Liver volume
Liver volume estimated by computed tomography
Secondary Outcome Measures
Liver volume
Liver volume estimated by computed tomography
Liver volume
Liver volume estimated by computed tomography
Liver volume
Liver volume estimated by computed tomography
Liver volume
Liver volume estimated by computed tomography
Liver volume
Liver volume estimated by computed tomography
Liver volume
Liver volume estimated by computed tomography
Full Information
NCT ID
NCT03803241
First Posted
November 18, 2016
Last Updated
September 22, 2021
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03803241
Brief Title
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
Acronym
cellcol
Official Title
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVE + CD133
Arm Type
Experimental
Arm Description
preop portal vein embolization + stem cells infusion
Arm Title
PVE
Arm Type
Sham Comparator
Arm Description
only preop portal vein embolization
Intervention Type
Drug
Intervention Name(s)
CD133+ infusion
Intervention Description
Infusion of cells cd133+
Intervention Type
Other
Intervention Name(s)
portal vein embolization
Intervention Description
portal vein embolization
Primary Outcome Measure Information:
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
once residual liver volume reach >40%, an average of 5 weeks.
Secondary Outcome Measure Information:
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 30 days
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 90 days
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 180 days
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 12 months
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 18 months
Title
Liver volume
Description
Liver volume estimated by computed tomography
Time Frame
Post-surgery follow-up visits the first 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
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.
Patients should have signed informed consent.
Exclusion criteria:
Pregnancy or lactation period.
Any condition that the investigators consider an unjustifiable risk in the patient.
Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
Patients who have not received research drugs in the last 30 days or in the period of 5 elimination half-life.
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.
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.
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Alejandra Garcia Botella
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32561087
Citation
Garcia-Botella A, Saez-Carlin P, Mendez R, Martin MP, Ortega L, Mendez JV, Garcia-Paredes B, Diez-Valladares L, Torres AJ. CD133 + cell infusion in patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL): A randomized open label clinical trial. Surg Oncol. 2020 Jun;33:224-230. doi: 10.1016/j.suronc.2019.10.005. Epub 2019 Oct 7.
Results Reference
derived
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Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
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