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 : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : June 16, 2020
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 harvesting.
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|
|Study Type :||Observational|
|Actual Enrollment :||490 participants|
|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 :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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
- 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.
- 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.
- 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.
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
|United States, Texas|
|Lung Institute Dallas|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Melissa Rubio, PhD||Principal Investigator|