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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02348060

Enrollment

100

Registered

2015-01-28

Start date

2015-11-30

Completion date

2019-05-31

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactHolly Bergen

800-609-7795

Outcome results