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

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

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

Sponsors & Collaborators

• Castilla y León Hematology and hemotherapy Foundation

  collaborator UNKNOWN

• Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán

  collaborator OTHER

• Spanish National Health System

  collaborator OTHER

• Red de Terapia Celular

  lead INDUSTRY

Principal Investigators

• Marcelo F Jiménez López, Ph.D · University Clinical Hospital of Salamanca

• Gonzalo Varela Simó, Ph.D · University Clinical Hospital of Salamanca

• Nuria M Novoa Valentín, Ph.D · University Clinical Hospital of Salamanca

• José L Aranda Alcaide, Ph.D · University Clinical Hospital of Salamanca

• Consuelo del Cañizo, Ph.D · University Clinical Hospital of Salamanca

• Fermín Sánchez-Guijo Martín, Ph.D · University Clinical Hospital of Salamanca

• Olga López Villar, Ph.D · University Clinical Hospital of Salamanca

• Eva M Villarón Ríos, Ph.D · University Clinical Hospital of Salamanca

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Spain

Study Locations