Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC)

This is an interventional treatment trial for Vocal Cord Paralysis, Unilateral focused on measuring adipose tissue, adult stem cells, vocal cord paralysis Read More

Inclusion Criteria:

• VC paralysis in paramedian position.
• Patients without previous compensation of the healthy contralateral VF.
• Males and females 18-years old or older.
• Women presenting the possibility of being pregnant must present a negative test of current pregnancy before the inclusion in the clinical trial (it must be certified at the minus 2 medical visit). It can be done by a blood test or a urinary test.
• The paralyzed VC should not be affected by granulomas, tumors o macroscopic objectable lesions by conventional laryngoscopy.
• The clinical situation of the patient must be ASA I or II following the parameters of the American Society of Anesthesiologists.
• There should not be any circumstance that could not afford the patient to follow the procedures of the clinical trial at least 6 months from the operation day.
• The patient must sign and confirm a specific informed acceptance to participate in the trial

Exclusion Criteria:

• Patients affected by kidney insufficiency, presenting a seric creatinine higher than 2.5 mg/dl.
• Medical history of allergy to proteins, or other allergies that could lead to a safety problem if the patient joins the present clinical trial.
• Acute infectious disease at the moment of enrollment.
• Chronic infectious disease affecting directly or indirectly the anatomical area that is going to be operated (it includes tuberculosis, brucellosis, chronic candidiasis and cutaneous chronic ulcers).
• Pregnancy or lactating patient.
• Patient needing a surgery in the anatomical area that is going to be operated on for a different reason at the moment of inclusion in the study, or patients in which it is suspected to perform surgeries in the mentioned anatomical area 24 weeks after the implant.
• Alcohol abuse or drugs abuse 6 months before the inclusion.
• Latent or active HIV infection or viral hepatitis.
• Patient suffered a major surgery or a major trauma 28 days before enrollment.
• Patients treated with immune-modulators (including therapy with systemic stem cells) 6 months before the inclusion in the study.
• Lung or heart disease that is unstable of presents a gravity that suggests to exclude the enrollment in the study.
• Life expectancy inferior to one year, in relation to comorbidities presenting in the moment of the clinical evaluation.
• Patients presenting deep venous thrombosis or lung thromboembolism, or patients who presented these diseases 6 months before the inclusion in the study.
• Patient presenting acquired or congenital immunodeficiencies.
• Patients presenting hemorrhagic diseases with INR>2,0, without anticoagulant treatment.
• Patients with any medical or psychiatric disorder that under the point of view of the researchers justifies the exclusion in the trial, because follow-up could be interrupted, because enrolment could be a risk for the patient or because it could be a risk for the global evaluation of the clinical trial.
• Patients enrolled currently in other clinical trials, or patients that participated in clinical trial 30 days before the inclusion in this study, if the previous one could not interfere in the participation or in the evaluation of the objectives of the present study.
• Patient who does not wish or cannot follow the procedures indicated in the clinical trial.
• Patients treated with platelet anti-aggregates or non-steroid anti-inflammatories 15 days before the surgery.