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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02348060
Other study ID # SVF01COPD
Secondary ID ASCCOPD-01
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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