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

Postoperative Air Leaks in Risk Patients Clinical Trial

— CSM/FAP/2012  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045745
• Other study ID #: CSM/FAP/2012
• Secondary ID: 2013-000535-27
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 22, 2014
• Last updated: March 29, 2017
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: Fermín Sánchez-Guijo Martín, Ph.D
• Phone: +34923294624
• Email: ferminsg[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Air Leaks in Risk Patients

Intervention

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

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Salamanca	Salamanca	Salamanca/Castilla León

Sponsors (4)

Lead Sponsor	Collaborator
Red de Terapia Celular	Castilla y León Hematology and hemotherapy Foundation, Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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