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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02348060
• Other study ID #: SVF01COPD
• Secondary ID: ASCCOPD-01
• Status: Recruiting
• Start date: November 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2018
• Source: StemGenex
• Contact: Holly Bergen
• Phone: 800-609-7795
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	StemGenex	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
StemGenex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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