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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 : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
StemGenex

Tracking Information
First Submitted Date January 22, 2015
First Posted Date January 28, 2015
Last Update Posted Date August 31, 2018
Study Start Date November 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02348060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 22, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease
Official Title Autologous Adipose Stromal Vascular Fraction Outcomes in Chronic Obstructive Pulmonary Disease Research Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Sample
Condition Chronic Obstructive Pulmonary Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 28, 2018)
100
Original Estimated Enrollment
 (submitted: January 22, 2015)
75
Estimated Study Completion Date May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Holly Bergen 800-609-7795
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02348060
Other Study ID Numbers SVF01COPD
ASCCOPD-01 ( Other Identifier: StemGenex )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party StemGenex
Study Sponsor StemGenex
Collaborators Not Provided
Investigators Not Provided
PRS Account StemGenex
Verification Date August 2018