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Autologous Stem Cell Treatment for Chronic Lung Disease Study

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ClinicalTrials.gov Identifier: NCT03044431
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Melissa Rubio, PhD, APRN, Lung Institute

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.


Condition or disease Intervention/treatment
COPD Interstitial Lung Disease Procedure: Cell therapy

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
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autologous Stem Cell Treatment for Chronic Lung Disease Study
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort Intervention/treatment
Cell therapy treated
All patients/participants enrolled will undergo cell therapy
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.




Primary Outcome Measures :
  1. 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

  2. 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).

  3. 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).


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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).

  4. 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).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will include all patients treated with cell therapy Lung Institute in Dallas, Texas.
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.

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): NCT03044431


Locations
United States, Texas
Lung Institute Dallas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Lung Institute
Investigators
Principal Investigator: Melissa Rubio, PhD, APRN Lung Institute Dallas
  Study Documents (Full-Text)

Documents provided by Melissa Rubio, PhD, APRN, Lung Institute:

Additional Information:
Responsible Party: Melissa Rubio, PhD, APRN, PhD, APRN, Lung Institute
ClinicalTrials.gov Identifier: NCT03044431     History of Changes
Other Study ID Numbers: LI001
First Posted: February 7, 2017    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa Rubio, PhD, APRN, Lung Institute:
Shortness of breath
Breathlessness
Stem cells
Platelet rich plasma
Quality of life
Pulmonary Function

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases