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 (CSM/FAP/2012)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Air Leaks in Risk Patients
• Intervention / Treatment: Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Fermín Sánchez-Guijo Martín, Ph.D; Phone Number: +34923294624; Email: ferminsg@usal.es

Study Locations

• Spain
  • Salamanca/Castilla León
    • Salamanca, Salamanca/Castilla León, Spain, 37007
      • Recruiting
      • University Clinical Hospital of Salamanca
      • Contact: Fermín Sánchez-Guijo Martín, Ph.D; Phone Number: +34923294624; Email: ferminsg@usal.es
      • Principal Investigator: Marcelo F Jiménez López, Ph.D
      • Sub-Investigator: Gonzalo Varela Simó, Ph.D
      • Sub-Investigator: Nuria M Novoa Valentín, Ph.D
      • Sub-Investigator: Jose L Aranda Alcaide, Ph.D
      • Sub-Investigator: Consuelo del Cañizo, Ph.D
      • Sub-Investigator: Fermín Sánchez-Guijo Martín, Ph.D
      • Sub-Investigator: Olga López Villar, Ph.D
      • Sub-Investigator: Eva M Villarón Ríos, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 70 years
• Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)
• Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria.

Exclusion Criteria:

Patients with any of the following exclusion criteria may not be included in the clinical trial:

• Those considered by the investigator are not on a good position to tolerate the procedure
• Clinical criteria and anesthetics that contraindicate surgery
• Uncontrolled severe disease
• Pregnant women
• Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus
• People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization
• The absence of informed consent or revocation thereof

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged postoperative air leaks in risk patients.; Patients with prolonged postoperative air leaks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the procedure	Security is measured in terms of: Adverse effects derived from the implantation of the CSM	During the procedure and postoperative period (48 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze the efficacy of the procedure	Clinical: Duration of postoperative air leak; Amount of leakage and trends measured by digital memory device; Cardiorespiratory complications Radiological: Pneumothorax on chest radiograph.	Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Red de Terapia Celular
• Collaborators: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán; Spanish National Health System; Castilla y León Hematology and hemotherapy Foundation
• Investigators: Principal Investigator: Marcelo F Jiménez López, Ph.D, University Clinical Hospital of Salamanca; Study Chair: Gonzalo Varela Simó, Ph.D, University Clinical Hospital of Salamanca; Study Chair: Nuria M Novoa Valentín, Ph.D, University Clinical Hospital of Salamanca; Study Chair: José L Aranda Alcaide, Ph.D, University Clinical Hospital of Salamanca; Study Director: Consuelo del Cañizo, Ph.D, University Clinical Hospital of Salamanca; Study Chair: Fermín Sánchez-Guijo Martín, Ph.D, University Clinical Hospital of Salamanca; Study Chair: Olga López Villar, Ph.D, University Clinical Hospital of Salamanca; Study Chair: Eva M Villarón Ríos, Ph.D, University Clinical Hospital of Salamanca

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Postoperative air leaks in risk patients.
• Other Study ID Numbers: CSM/FAP/2012; 2013-000535-27 (EudraCT Number)