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)

The Cellular Therapy Network (TerCel)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Postoperative Air Leaks in Risk Patients

Treatments

Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02045745

2013-000535-27 (EudraCT Number)

CSM/FAP/2012

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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