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Trial record 5 of 3461 for:    Respiratory Disease | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

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

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ClinicalTrials.gov Identifier: NCT02348060
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
StemGenex

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
Chronic Obstructive Pulmonary Disease

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Adipose Stromal Vascular Fraction Outcomes in Chronic Obstructive Pulmonary Disease Research Study
Study Start Date : November 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases




Primary Outcome Measures :
  1. 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) [ Time Frame: 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 :
  1. 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 [ Time Frame: Baseline, Month 12 ]
    Participant assessment of breathing comfort from baseline to month 12 using the CRQ-SAI dyspnea subscale.

  2. 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 [ Time Frame: Baseline, Month 12 ]
    Participant assessment of fatigue from baseline to month 12 using the CRQ-SAI fatigue subscale.

  3. 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 [ Time Frame: Baseline, Month 12 ]
    Participant assessment of emotional function from baseline to month 12 using the CRQ-SAI emotional function subscale.

  4. 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348060


Contacts
Contact: Holly Bergen 800-609-7795

Locations
United States, California
StemGenex Recruiting
La Jolla, California, United States, 92037
Contact    800-541-4740      
Sponsors and Collaborators
StemGenex

Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02348060     History of Changes
Other Study ID Numbers: SVF01COPD
ASCCOPD-01 ( Other Identifier: StemGenex )
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases