Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak … (NCT02045745) | Clinical Trial Compass
UnknownPhase 1/2
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
Spain10 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the procedure
Timeframe: During the procedure and postoperative period (48 hours)