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

Phase 1

• 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

• Registration Number: NCT02045745
• Lead Sponsor: Red de Terapia Celular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolonged postoperative air leaks in risk patients.	Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line	Patients with prolonged postoperative air leaks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinical Hospital of Salamanca; 🇪🇸 Salamanca, Salamanca/Castilla León, Spain