Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders

Conditions
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Lung Disease

Intervention / Treatment
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* Procedure: lipoaspiration
* Procedure: ADcSVF
* Procedure: Normal Saline IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior Diagnosis of moderate to severe COPD GOLD II a, III, IV Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipoaspiration Arm 1<br>Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat | Procedure: lipoaspiration<br>* Closed syringe harvesting subdermal fat<br>|
| Experimental: AD-cSVF Arm 2<br>Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF) | Procedure: ADcSVF<br>* Isolation of AD-cSVF<br>|
| Experimental: Normal Saline IV Arm 3<br>Normal Saline IV with AD-cSVF cells | Procedure: Normal Saline IV<br>* Normal Saline IV containing AD-cSVF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Pulmonary Function | Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study | 12 months Evaluate Function and Adverse Events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Respiratory Rate | Measured rate clinically at rest | 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 | 1 year | 
| Change from baseline 6 Minute Walk Test | Exercise capacity measured by distance a patient can walk in 6 minute timeframe | 12 Months | 
| Change from Baseline Lung X-Ray | standard flat film x-ray | 6 months, 12 months | 
| Change from Baseline SGOT Blood Testing | Measure Blood Serum Glutamate Oxaloacetate Transaminase (SGOT) Measure Blood Elevation with liver damage | 1 Month | 
| Change from Baseline SGPT Blood Testing | Measure Blood Serum Glutamate Pyruvate Transaminase (SGPT) elevation with liver damage | 1 Month | 
| Pulmonary Function Testing | Measure Baseline Pulmonary Function (FEV/FEVi Measure) | Baseline, 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Emphysema