Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
- Conditions
- Lung Disease
- Interventions
- Procedure: lipoaspirationProcedure: ADcSVFProcedure: Normal Saline IV
- Registration Number
- NCT02946658
- Lead Sponsor
- Healeon Medical Inc
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- Prior Diagnosis of moderate to severe COPD
- GOLD II a, III, IV
- Pregnant or Lactating Females
- Life expectancy of < 3 months due to concomitant illnesses
- Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results
- Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes
- Subjects on chronic immunosuppressive or chemotherapeutic medications
- Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.
- Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)
- Unwilling or not competent to understand and execute an informed consent agreement
- Patients positive for Hepatitis (Hepatitis A history excepted)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lipoaspiration Arm 1 lipoaspiration Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat AD-cSVF Arm 2 ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) Normal Saline IV Arm 3 Normal Saline IV Normal Saline IV with AD-cSVF cells
- Primary Outcome Measures
Name Time Method Safety - Pulmonary Function 12 months Evaluate Function and Adverse Events Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
- Secondary Outcome Measures
Name Time Method Change from baseline 6 Minute Walk Test 12 Months Exercise capacity measured by distance a patient can walk in 6 minute timeframe
Change from Baseline Lung X-Ray 6 months, 12 months standard flat film x-ray
Change from Baseline SGOT Blood Testing 1 Month Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage
Change from Baseline SGPT Blood Testing 1 Month Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage
GOLD Classification 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 Respiratory Rate 1 month, 6 month, 1 year Measured rate clinically at rest
Pulmonary Function Testing Baseline, 6 Months Measure Baseline Pulmonary Function (FEV/FEVi Measure)
Trial Locations
- Locations (2)
Global Alliance for Regenerative Medicine (GARM)
🇭🇳Roatan, HN, Honduras
Regenevita LLC
🇺🇸Stevensville, Montana, United States