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Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases. (cellcol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803241
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Alejandra Garcia Botella, 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: CD133+ infusion Other: portal vein embolization Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
Actual Study Start Date : May 2015
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: PVE + CD133
preop portal vein embolization + stem cells infusion
Drug: CD133+ infusion
Other: portal vein embolization
Sham Comparator: PVE
only preop portal vein embolization
Other: portal vein embolization



Primary Outcome Measures :
  1. Liver volume [ Time Frame: once residual liver volume reach >40%, an average of 5 weeks. ]
    Liver volume estimated by computed tomography


Secondary Outcome Measures :
  1. Liver volume [ Time Frame: Post-surgery follow-up visits the first 30 days ]
    Liver volume estimated by computed tomography

  2. Liver volume [ Time Frame: Post-surgery follow-up visits the first 90 days ]
    Liver volume estimated by computed tomography

  3. Liver volume [ Time Frame: Post-surgery follow-up visits the first 180 days ]
    Liver volume estimated by computed tomography

  4. Liver volume [ Time Frame: Post-surgery follow-up visits the first 12 months ]
    Liver volume estimated by computed tomography

  5. Liver volume [ Time Frame: Post-surgery follow-up visits the first 18 months ]
    Liver volume estimated by computed tomography

  6. Liver volume [ Time Frame: Post-surgery follow-up visits the first 24 months ]
    Liver volume estimated by computed tomography



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  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.

Exclusion criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803241


Locations
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Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28031
Contact: ALEJANDRA GARCIA BOTELLA    687488278    sandragbotella@hotmail.es   
Alejandra Garcia Botella Not yet recruiting
Madrid, Spain, 28040
Contact: alejandra garcia botella    +34913303000 ext 3184    alejandramaria.garcia@salud.madrid.org   
Contact: uicec fundación para la investigación biomedica HCSC    +34913303000 ext 2774    fibucicec.hcsc@salud.madrid.org   
Sponsors and Collaborators
Hospital San Carlos, Madrid
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandra Garcia Botella, Principal investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03803241    
Other Study ID Numbers: 2014-001402-18
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes