Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration
This is a randomized controlled trial in which the safety and feasibility of cell therapy medicinal product shall be measured by comparing the variables of the response after treatment compared to baseline prior to implementation. Secondarily the results obtained are compared with each of the study groups.
Patients will receive concomitant basic pharmacological treatment for maintaining liver function.
All patients will be equally medically treated. The hypothetic test is to propose mononuclear cells from the bone marrow infused in the territory hepatic portal remaining segments (II and III) to be performed while contralateral portal embolization provides progenitor cells hepatic regenerative capacity that would shorten the time of liver regeneration and increase residual volume, facilitating the realization of an extended hepatectomy with greater assurance of maintaining proper residual function and adequate surgical margins.
|Liver Transplant Rejection||Other: Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial Phase II Multicenter Open Randomized Trial of the Therapeutic Use of Cells Intraportal Infusion of Autologous Bone Marrow Mononuclear as Enhancing Liver Regeneration Prior to Performing Extended Hepatic Resection.|
- Number of adverse events and serious adverse events [ Time Frame: 6 after drug administration of cell therapy. ]First 24 hours after administration of the mo-MNC, and monitoring at weeks 2,4 and 6 after drug administration of cell therapy.
- Changes in volume hepatic after application of hepatic regeneration procedures before surgery. [ Time Frame: 12 months ]
|Study Start Date:||March 2011|
|Study Completion Date:||December 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients with hepatic space occupying lesion requiring an extended hepatic resection to those who were preoperatively performed a Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.
Other: Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.
Proceeds to selective application of stem cells in the portal branches of segments II and III as 10 ml aliquots of taking a time of 4 minutes between each application.
No Intervention: Control
Patients with hepatic space occupying lesion that require an extended liver resection that were performed preoperatively portal embolization of the affected segments.
The study population corresponds to patients with hepatic space occupying lesion that require extended hepatic resection and in which the residual liver volume is insufficient to ensure liver function as well as required safety margins after resection.
The study population will consist of a total of 65 patients divided into two groups:
Study group: patients with hepatic space occupying lesion requiring an extended hepatic resection to those who are undergoing preoperative embolization segments portal intraportal affections and application of bone marrow cells.
Control group: patients with hepatic space occupying lesion that require an extended liver resection and who were performed preoperatively embolization portal of the affected segments.
The distribution of cases / controls will be 1/1. Patients in study group before surgery as well as portal embolization of the affected by the injury, will receive the experimental treatment being tested. Autologous bone marrow will be extracted by aspiration of the iliac crest under local anesthesia, and then the mononuclear cells (mo-MNCs) will be separated by density gradient centrifugation on Ficoll by an automatic procedure in the Laboratory for Cell Therapy.
In the control group patients will be held an embolization of liver segments in which are located the lesion.
It is estimated that the inclusion period is approximately 24 months plus the follow-up of each patient twelve months. Thus the total duration of the study will be about thirty-six months from the entry of the first patient until the end of the monitoring period of the last patient included.
The main objective is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells as autologous liver regeneration enhancer, administered intraportal before surgery in patients with liver space occupying lesion that require extended hepatic resection and in which the residual liver volume is insufficient to ensure liver function and safety margins required after the resection.
- Complications from regenerative therapy and / or study procedures.
- Increased volume obtained after applying the procedures of liver regeneration after surgery.
- The percentage of resections that has allowed liver regeneration.
- The liver functional status after surgery.
- The resection margins free of tumor.
Radiological assessment of liver volumes. Analytical evaluation of markers of regeneration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745731
|University Hospital Virgen del Rocio|
|Sevilla, Spain, 41013|
|Principal Investigator:||Francisco Javier Padillo, MD||Head of General and Digestive Surgery, University Hospital Virgen del Rocio|
|Principal Investigator:||Antonio Galindo, MD||Head of General and Digestive Surgery, University Hospital Nuestra Señora de Valme|
|Principal Investigator:||Daniel Garrote, MD||Section Chief of General Surgery, University Hospital Virgen de las Nieves|
|Principal Investigator:||Sebastian Rufian, MD||Head of General and Digestive Surgery, University Hospital Reina Sofia|
|Study Chair:||Francisco Javier Padillo, MD||Head of General and Digestive Surgery, University Hospital Virgen del Rocio|