Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.

NCT03803241 | Completed Phase 2

• 1 other identifier: 2014-001402-18
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Liver volume

  Liver volume estimated by computed tomography

  once residual liver volume reach >40%, an average of 5 weeks.

Secondary Outcomes (6)

• Liver volume

  Post-surgery follow-up visits the first 30 days

• Liver volume

  Post-surgery follow-up visits the first 90 days

• Liver volume

  Post-surgery follow-up visits the first 180 days

• Liver volume

  Post-surgery follow-up visits the first 12 months

• Liver volume

  Post-surgery follow-up visits the first 18 months

Study Arms (2)

PVE + CD133

EXPERIMENTAL

preop portal vein embolization + stem cells infusion

Drug: CD133+ infusion; Other: portal vein embolization

PVE

SHAM COMPARATOR

only preop portal vein embolization

Other: portal vein embolization

Interventions

CD133+ infusion DRUG

Infusion of cells cd133+

PVE + CD133

portal vein embolization OTHER

portal vein embolization

PVE; PVE + CD133

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (2)

Hospital Clinico San Carlos

Madrid, 28031, Spain

Location

Alejandra Garcia Botella

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 32561087 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: January 14, 2019
• Study Start: May 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

ES (2)