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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

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.

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02045745
Acronym
CSM/FAP/2012
Enrollment
10
Registered
2014-01-27
Start date
2013-12-31
Completion date
2017-12-31
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Air Leaks in Risk Patients

Keywords

Postoperative air leaks in risk patients.

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.

Interventions

BIOLOGICALImplantation 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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety of the procedureDuring the procedure and postoperative period (48 hours)Security is measured in terms of: Adverse effects derived from the implantation of the CSM

Secondary

MeasureTime frameDescription
Analyze the efficacy of the procedurePostoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 monthsClinical: * Duration of postoperative air leak * Amount of leakage and trends measured by digital memory device * Cardiorespiratory complications Radiological: * Pneumothorax on chest radiograph.

Countries

Spain

Contacts

Primary ContactFermín Sánchez-Guijo Martín, Ph.D
ferminsg@usal.es+34923294624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026