COPD Clinical Trial
Official title:
Autologous Stem Cell Treatment for Chronic Lung Disease Study
NCT number | NCT03044431 |
Other study ID # | LI001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | June 9, 2017 |
Verified date | October 2018 |
Source | Lung Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 207 |
Est. completion date | June 9, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Lung Institute Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Lung Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores | 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). | Measurements for COPD pre-treatment and then at 3 months post-treatment | |
Other | Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores | 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). | Measurements for COPD pre-treatment and then at 6 months post-treatment | |
Other | Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores | 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). | Measurements for ILD pre-treatment and then at 3 months post-treatment | |
Other | Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores | 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). | Measurements for ILD pre-treatment and then at 6 months post-treatment | |
Primary | Change in FEV1 From Baseline Among COPD Patients | Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment | Measurements pre-treatment and then at 6 months post- treatment | |
Primary | Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, 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). | Measurements pre-treatment and then at 3 months post-treatment for all diagnoses | |
Primary | Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, 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). | Measurements pre-treatment and then at 6 months post-treatment among all diagnoses |
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