NCT02045745UnknownPhase 1
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.
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Red de Terapia Celular
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety of the procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 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
Arms & Interventions
Prolonged postoperative air leaks in risk patients.
Experimental
Patients with prolonged postoperative air leaks
Intervention: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line (Biological)
Outcomes
Primary Outcomes
Safety of the procedure
Time Frame: During the procedure and postoperative period (48 hours)
Security is measured in terms of: Adverse effects derived from the implantation of the CSM
Secondary Outcomes
- Analyze the efficacy of the procedure(Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months)
Investigators
Study Sites (1)
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