NCT02045745

Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells

CLINICAL TRIAL PHASE I / II, PROSPECTIVE, OPEN, NONRANDOMIZED, FOR TREATMENT OF POSTOPERATIVE AIR LEAK AFTER LUNG RESECTION IN HIGH RISK PATIENTS THROUGH THE ADMINISTRATION OF MESENCHYMAL AUTOLOGOUS CELLS.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Red de Terapia Celular · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.

Conditions

• Postoperative Air Leaks in Risk Patients

Interventions

Type	Name	Description
BIOLOGICAL	Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line	Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-01-27
• Last updated: 2017-03-30

Locations

1 site across 1 country: Spain