Outcomes Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with chronic obstructive pulmonary disease (COPD). SVF contains multiple cellular components, including stem cells, with both regenerative and anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of COPD. This study is designed to evaluate quality of life changes in individuals with COPD for up to 12 months following SVF treatment.

Official Title
-----------------
Autologous Adipose Stromal Vascular Fraction Outcomes in Chronic Obstructive Pulmonary Disease Research Study

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with chronic obstructive pulmonary disease (COPD) Subjects scheduled for a stem cell/SVF treatment Subjects willing and able to sign informed consent Subjects willing and able to perform follow-up interviews and surveys Exclusion Criteria: Subjects with additional major health condition/disease diagnoses Subjects that are pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) | The change from baseline over the course of 12 months using participants' assessment of their overall quality of life. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are given as a seven point Likert response scale. | Baseline, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Overall Breathing Comfort at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Dyspnea Subscale | Participant assessment of breathing comfort from baseline to month 12 using the CRQ-SAI dyspnea subscale. | Baseline, Month 12 | 
| Change from Baseline in Overall Fatigue at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Fatigue Subscale | Participant assessment of fatigue from baseline to month 12 using the CRQ-SAI fatigue subscale. | Baseline, Month 12 | 
| Change from Baseline in Overall Emotional Function at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Emotional Function Subscale | Participant assessment of emotional function from baseline to month 12 using the CRQ-SAI emotional function subscale. | Baseline, Month 12 | 
| Change from Baseline in Mastery at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Mastery Subscale | Participant assessment of mastery (the ability to control feelings of disease-related fear or panic) from baseline to month 12 using the CRQ-SAI mastery subscale. | Baseline, Month 12 |