Outcomes Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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) [Baseline, 12 Months]
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.
Secondary Outcome Measures
- 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 [Baseline, Month 12]
Participant assessment of breathing comfort from baseline to month 12 using the CRQ-SAI dyspnea subscale.
- 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 [Baseline, Month 12]
Participant assessment of fatigue from baseline to month 12 using the CRQ-SAI fatigue subscale.
- 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 [Baseline, Month 12]
Participant assessment of emotional function from baseline to month 12 using the CRQ-SAI emotional function subscale.
- 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 [Baseline, Month 12]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects diagnosed with chronic obstructive pulmonary disease (COPD)
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Subjects scheduled for a stem cell/SVF treatment
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Subjects willing and able to sign informed consent
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Subjects willing and able to perform follow-up interviews and surveys
Exclusion Criteria:
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Subjects with additional major health condition/disease diagnoses
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Subjects that are pregnant or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | StemGenex | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- StemGenex
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SVF01COPD
- ASCCOPD-01