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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • StemGenex
      • Contact: Phone Number: 800-541-4740

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community Sample

Description

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 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

Collaborators and Investigators

• Sponsor: StemGenex

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (ESTIMATE): January 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SVF01COPD; ASCCOPD-01 (OTHER: StemGenex)