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Autologous Stem Cell Treatment for Chronic Lung Disease Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044431
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : October 25, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Rubio, PhD, APRN, Lung Institute

Tracking Information
First Submitted Date February 3, 2017
First Posted Date February 7, 2017
Results First Submitted Date June 27, 2017
Results First Posted Date October 25, 2017
Last Update Posted Date October 15, 2018
Actual Study Start Date April 1, 2016
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2017)
  • Change in FEV1 From Baseline Among COPD Patients [ Time Frame: Measurements pre-treatment and then at 6 months post- treatment ]
    Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment
  • Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses [ Time Frame: Measurements pre-treatment and then at 3 months post-treatment for all diagnoses ]
    Number of patients in the total sample who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
  • Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses [ Time Frame: Measurements pre-treatment and then at 6 months post-treatment among all diagnoses ]
    Number of patients in the total sample who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
Original Primary Outcome Measures
 (submitted: February 3, 2017)
  • Change in quality of life (QOL) form baseline [ Time Frame: Measurements pre-treatment and then at 3 months and 6 months post-treatment ]
    Change from baseline in overall perceived quality of life over the course of a 6-month period as measured by the Clinical COPD Questionnaire (CCQ).
  • Change in FEV1 From Baseline Among COPD Patients [ Time Frame: Measurements pre-treatment and then at 6 months post- treatment ]
    Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2017)
  • Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores [ Time Frame: Measurements for COPD pre-treatment and then at 3 months post-treatment ]
    Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
  • Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores [ Time Frame: Measurements for COPD pre-treatment and then at 6 months post-treatment ]
    Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
  • Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores [ Time Frame: Measurements for ILD pre-treatment and then at 3 months post-treatment ]
    Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
  • Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores [ Time Frame: Measurements for ILD pre-treatment and then at 6 months post-treatment ]
    Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autologous Stem Cell Treatment for Chronic Lung Disease Study
Official Title Autologous Stem Cell Treatment for Chronic Lung Disease Study
Brief Summary

The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung Institute's treatment is limited to self-funded patients with chronic lung disease- chronic obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are harvested through venous or bone marrow collection techniques.

The hypothesized outcomes of therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their perceived quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce supplemental oxygen use, the ability to function well without the use of rescue inhalers, reduction of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

Detailed Description Through the collection of outcomes data, Lung Institute aims to explore and describe the safety and efficacy of autologous stem cell treatment for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. The study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function over time, and to describe the anecdotal quality of life changes of patients following treatment using quantitative and qualitative measures.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will include all patients treated with cell therapy Lung Institute in Dallas, Texas.
Condition
  • COPD
  • Interstitial Lung Disease
Intervention Procedure: Cell therapy
Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day.
Study Groups/Cohorts Cell therapy treated
All patients/participants enrolled will undergo cell therapy
Intervention: Procedure: Cell therapy
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 Completed
Actual Enrollment
 (submitted: September 26, 2017)
207
Original Actual Enrollment
 (submitted: February 3, 2017)
214
Actual Study Completion Date June 9, 2017
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. All eligible treated patients are eligible for the study.

Exclusion Criteria:

  • Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. In addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03044431
Other Study ID Numbers LI001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Melissa Rubio, PhD, APRN, Lung Institute
Study Sponsor Lung Institute
Collaborators Not Provided
Investigators
Principal Investigator: Melissa Rubio, PhD, APRN Lung Institute Dallas
PRS Account Lung Institute
Verification Date October 2018