Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders (ADcSVF-COPD)
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|ClinicalTrials.gov Identifier: NCT02946658|
Recruitment Status : Enrolling by invitation
First Posted : October 27, 2016
Last Update Posted : August 3, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Disease||Procedure: lipoaspiration Procedure: ADcSVF Procedure: Normal Saline IV||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||August 14, 2024|
|Estimated Study Completion Date :||August 14, 2024|
Experimental: Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
Closed syringe harvesting subdermal fat
Experimental: AD-cSVF Arm 2
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
Isolation of AD-cSVF
Experimental: Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
Procedure: Normal Saline IV
Normal Saline IV containing AD-cSVF
- Safety - Pulmonary Function [ Time Frame: 12 months Evaluate Function and Adverse Events ]Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
- Change from Baseline Respiratory Rate [ Time Frame: 1 month, 6 month, 1 year ]Measured rate clinically at rest
- GOLD Classification [ Time Frame: 1 year ]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
- Change from baseline 6 Minute Walk Test [ Time Frame: 12 Months ]Exercise capacity measured by distance a patient can walk in 6 minute timeframe
- Change from Baseline Lung X-Ray [ Time Frame: 6 months, 12 months ]standard flat film x-ray
- Change from Baseline SGOT Blood Testing [ Time Frame: 1 Month ]Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
- Change from Baseline SGPT Blood Testing [ Time Frame: 1 Month ]Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
- Pulmonary Function Testing [ Time Frame: Baseline, 6 Months ]Measure Baseline Pulmonary Function (FEV/FEVi Measure)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946658
|United States, Montana|
|Stevensville, Montana, United States, 59870|
|Global Alliance for Regenerative Medicine (GARM)|
|Roatan, HN, Honduras|
|Principal Investigator:||Robert W Alexander, MD||Healeon Medical Inc|
|Principal Investigator:||Glenn C. Terry, MD||Global Alliance for Regenerative Medicine (GARM)|