An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
Completed
Conditions studied: COPD, Interstitial Lung Disease
In brief
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.
Key facts
- Study ID
- NCT03040674
- Run by
- Lung Institute
- People needed
- 489
- Starts
- 2017-01-03
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-04-27
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Lung Institute Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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