Clinical trial NCT02045745: 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
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Air Leaks in Risk Patients
Keywords: Postoperative air leaks in risk patients.
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Castilla y León Hematology and hemotherapy Foundation
name: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
name: Spanish National Health System
First posted: 2014-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of the procedure
timeFrame: During the procedure and postoperative period (48 hours)
Secondary outcomes:
measure: Analyze the efficacy of the procedure
timeFrame: Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University Clinical Hospital of Salamanca
state: Salamanca/Castilla León
Study officials:
affiliation: University Clinical Hospital of Salamanca
name: Marcelo F Jiménez López, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinical Hospital of Salamanca
name: Gonzalo Varela Simó, Ph.D
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Salamanca
name: Nuria M Novoa Valentín, Ph.D
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Salamanca
name: José L Aranda Alcaide, Ph.D
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Salamanca
name: Consuelo del Cañizo, Ph.D
role: STUDY_DIRECTOR
affiliation: University Clinical Hospital of Salamanca
name: Fermín Sánchez-Guijo Martín, Ph.D
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Salamanca
name: Olga López Villar, Ph.D
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Salamanca
name: Eva M Villarón Ríos, Ph.D
role: STUDY_CHAIR
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