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

NCT01745731 | Completed Phase 2 DMC

• 2 other identifiers: CMMo/RH/20092009-017793-20
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of adverse events and serious adverse events

  First 24 hours after administration of the mo-MNC, and monitoring at weeks 2,4 and 6 after drug administration of cell therapy.

  6 after drug administration of cell therapy.

Secondary Outcomes (1)

• Changes in volume hepatic after application of hepatic regeneration procedures before surgery.

  12 months

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Control

NO INTERVENTION

Patients with hepatic space occupying lesion that require an extended liver resection that were performed preoperatively portal embolization of the affected segments.

Interventions

Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments. OTHER

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.

Experimental

Eligibility Criteria

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

You may qualify if:

• \- Patients of both sexes aged ≥ 18 years.
• \- Standard analytical parameters, defined by:
• Leukocytes ≥ 3000
• Neutrophils ≥ 1500
• Platelets ≥ 100,000
• Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 1.5 standard range institution
• creatinine ≤ 1.5 mg / dl
• \- Patients with liver space occupying lesion (LOE) that require extended hepatic resection.
• Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry:
• Metastatic Disease subsidiary right hepatectomy extended to segment IV
• Metastatic Disease subsidiary right hepatectomy with suspected diseased liver (neoadjuvant chemotherapy) (in cases of doubt may be used liver function test "indocyanine green")
• Bilobar liver metastases with multiple nodules in the right lobe and more than 3 nodules greater than 30 mm in the left hepatic lobe (LHI) will perform lumpectomies the LHI + right portal branch ligation (or postoperative percutaneous embolization) in order to make right hepatectomy 4-6 weeks ("two stage" surgery)
• Subsidiary Hepatocarcinoma extended right hepatectomy
• Liver Injury benign / malignant (Hemangiomas, hydatid cysts or liver tumors / primary bile hepatoblastoma), which by extension threatens the viability of the remaining liver tissue.
• Patients give their written informed consent for participation in the study and provide sufficient guarantees adherence to protocol according to the opinion of the investigator in charge of the patient care.

You may not qualify if:

• Different tumor records current disease or any disease hematologic.
• Patients with uncontrolled hypertension.
• Severe heart failure (NYHA IV).
• Patients with malignant ventricular arrhythmias or unstable angina.
• Diagnosis of deep vein thrombosis in the previous 3 months.
• Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II.
• BMI\> 40 kg/m2.
• Patients with alcoholic with active alcoholism.
• Proliferative retinopathy.
• Concomitant disease that reduces life expectancy to less than a year.
• Difficulty in monitoring.
• Heart failure or ejection fraction (EF) \<30%.
• Stroke or myocardial infarction within the last 3 months.
• Pregnant women or women of childbearing age who do not have adequate contraception.

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (1)

University Hospital Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location

Related Links

• Andalusian Molecular Biology and Regenerative Medicine Centre

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Francisco Javier Padillo, MD

  Head of General and Digestive Surgery, University Hospital Virgen del Rocio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 10, 2012
• Study Start: March 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

ES (1)