Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange. Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators. Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.
COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations. As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010. This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Closed syringe harvesting subdermal fat
Isolation of AD-cSVF
Normal Saline IV containing AD-cSVF
Regenevita LLC
Stevensville, Montana, United States
Global Alliance for Regenerative Medicine (GARM)
Roatán, HN, Honduras
Safety - Pulmonary Function
Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
Time frame: 12 months Evaluate Function and Adverse Events
Change from Baseline Respiratory Rate
Measured rate clinically at rest
Time frame: 1 month, 6 month, 1 year
GOLD Classification
Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a COPD staging system based on degree of airflow limitations (obstruction) and measured by pulmonary function studies
Time frame: 1 year
Change from baseline 6 Minute Walk Test
Exercise capacity measured by distance a patient can walk in 6 minute timeframe
Time frame: 12 Months
Change from Baseline Lung X-Ray
standard flat film x-ray
Time frame: 6 months, 12 months
Change from Baseline SGOT Blood Testing
Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
Time frame: 1 Month
Change from Baseline SGPT Blood Testing
Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
Time frame: 1 Month
Pulmonary Function Testing
Measure Baseline Pulmonary Function (FEV/FEVi Measure)
Time frame: Baseline, 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.