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An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT03040674
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : March 6, 2018
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 same-day. Lung Institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are collected through venous or bone marrow harvesting techniques.

The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their ability to be more physically active; walking greater distances with or without oxygen and improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability to reduce their use of oxygen and possibly to stop it., the ability to function well without the use of rescue inhalers, reduction or ceasing 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 outcome 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, and to describe the anecdotal quality of life changes of patients following treatment using both quantitative and qualitative measures.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : January 3, 2019
Estimated Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine


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 quality of life (QOL) from baseline [ Time Frame: Measurements pre-treatment then at 3 and 6 months post-treatment ]
    • Change from baseline in overall perceived quality of life over the course of a 12 month period as measured by the Clinical COPD Questionnaire (CCQ) The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ.

  2. Change in MMRC scale from baseline [ Time Frame: Measurements pre-treatment then at 3 and 6 months post-treatment ]
    • Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 6 months using the participant's self-reported response to the MMRC. Mean scores will be used at baseline (day 0) and at months 3 and 6.

  3. Change in FEV1 from baseline [ Time Frame: Measurements pre-treatment and at 6 months post-treatment ]

    •Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.

    The change from baseline in FEV1 as measured by pulmonary function testing/spirometry over the course of 6 months. Scores will be used at baseline (day 0) and at 6 months.




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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 at Lung Institute Dallas.
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 nurse practitioner or physician of the Lung Institute who determines final eligibility for treatment. All eligible and thereby traded 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): NCT03040674


Contacts
Contact: Melissa Rubio, PhD 855-543-6299 mrubio@lunginstitute.com
Contact: Sreedevi Marakatham, MD 855-543-6299 smarakatham@lunginstitute.com

Locations
United States, Texas
Lung Institute Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Melissa Rubio, PhD, APRN    800-729-3065    mrubio@lunginstitute.com   
Contact: Sreedevi Marakatham, MD    1-800-729-3065    smarakatham@lunginstitute.com   
Sponsors and Collaborators
Lung Institute
Investigators
Principal Investigator: Melissa Rubio, PhD Principal Investigator

Additional Information:
Responsible Party: Melissa Rubio, PhD, APRN, Principal Investigator, Lung Institute
ClinicalTrials.gov Identifier: NCT03040674     History of Changes
Other Study ID Numbers: LI002
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
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