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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Air Leaks in Risk Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prolonged postoperative air leaks in risk patients.

Patients with prolonged postoperative air leaks

Group Type EXPERIMENTAL

Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line

Intervention Type BIOLOGICAL

Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro

Interventions

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Implantation 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 70 years
* Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR