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Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration

NCT01745731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-12-14

No results posted yet for this study

Summary

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.

Conditions

  • Liver Transplant Rejection

Interventions

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.

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

  • Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

    lead OTHER

Principal Investigators

  • Francisco Javier Padillo, MD · Head of General and Digestive Surgery, University Hospital Virgen del Rocio

  • Antonio Galindo, MD · Head of General and Digestive Surgery, University Hospital Nuestra Señora de Valme

  • Daniel Garrote, MD · Section Chief of General Surgery, University Hospital Virgen de las Nieves

  • Sebastian Rufian, MD · Head of General and Digestive Surgery, University Hospital Reina Sofia

  • Francisco Javier Padillo, MD · Head of General and Digestive Surgery, University Hospital Virgen del Rocio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-01-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745731 on ClinicalTrials.gov