Clinical trial NCT03040674: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
Official title: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Interstitial Lung Disease
Keywords: Shortness of breath
Breathlessness
Cellular therapy
Platelet rich plasma
Quality of life
Pulmonary function
Lead sponsor: Lung Institute
Sponsor class: INDUSTRY
First posted: 2017-02-02
Enrollment: 489
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include all patients treated with cell therapy at Lung Institute Dallas.

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 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.

Detailed description: Through the collection of outcome data, Lung Institute aims to explore and describe the safety and efficacy of autologous cellular therapy 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.

Eligibility 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.

Primary outcomes:
measure: Change in Quality of Life (QOL) From Baseline
timeFrame: Measurements pre-treatment then at 3 and 6 months post-treatment
measure: Change in MMRC Scale From Baseline
timeFrame: Measurements pre-treatment then at 3 months post-treatment
measure: Change in FEV1 From Baseline
timeFrame: Measurements pre-treatment and at 3 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lung Institute Dallas
state: Texas
Study officials:
affiliation: Principal Investigator
name: Melissa Rubio, PhD
role: PRINCIPAL_INVESTIGATOR
References: