Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000535-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Castilla y León Hematology and hemotherapy Foundation | UNKNOWN |
| Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán | OTHER |
| Spanish National Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged postoperative air leaks in risk patients. | Experimental | Patients with prolonged postoperative air leaks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line | Biological | Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the efficacy of the procedure | Clinical:
Radiological:
| Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with any of the following exclusion criteria may not be included in the clinical trial:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fermín Sánchez-Guijo Martín, Ph.D | Contact | +34923294624 | ferminsg@usal.es |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo F Jiménez López, Ph.D | University Clinical Hospital of Salamanca | Principal Investigator |
| Gonzalo Varela Simó, Ph.D | University Clinical Hospital of Salamanca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital of Salamanca | Recruiting | Salamanca | Salamanca/Castilla León | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37904229 | Derived | Jimenez MF, Gomez-Hernandez MT, Villaron EM, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded with Tissucol Duo(R) for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2023 Oct 31;14(1):313. doi: 10.1186/s13287-023-03545-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nuria M Novoa Valentín, Ph.D |
| University Clinical Hospital of Salamanca |
| Study Chair |
| José L Aranda Alcaide, Ph.D | University Clinical Hospital of Salamanca | Study Chair |
| Consuelo del Cañizo, Ph.D | University Clinical Hospital of Salamanca | Study Director |
| Fermín Sánchez-Guijo Martín, Ph.D | University Clinical Hospital of Salamanca | Study Chair |
| Olga López Villar, Ph.D | University Clinical Hospital of Salamanca | Study Chair |
| Eva M Villarón Ríos, Ph.D | University Clinical Hospital of Salamanca | Study Chair |