Clinical trial NCT03044431: Autologous Stem Cell Treatment for Chronic Lung Disease Study
Official title: Autologous Stem Cell Treatment for Chronic Lung Disease Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Interstitial Lung Disease
Keywords: Shortness of breath
Breathlessness
Stem cells
Platelet rich plasma
Quality of life
Pulmonary Function
Lead sponsor: Lung Institute
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 207
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 Lung Institute in Dallas, Texas.

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 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.

Detailed description: Through the collection of outcomes 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 over time, and to describe the anecdotal quality of life changes of patients following treatment using 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 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.

Primary outcomes:
measure: Change in FEV1 From Baseline Among COPD Patients
timeFrame: Measurements pre-treatment and then at 6 months post- treatment
measure: Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses
timeFrame: Measurements pre-treatment and then at 3 months post-treatment for all diagnoses
measure: Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses
timeFrame: Measurements pre-treatment and then at 6 months post-treatment among all diagnoses
Secondary outcomes:
Other outcomes:
measure: Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores
timeFrame: Measurements for COPD pre-treatment and then at 3 months post-treatment
measure: Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores
timeFrame: Measurements for COPD pre-treatment and then at 6 months post-treatment
measure: Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores
timeFrame: Measurements for ILD pre-treatment and then at 3 months post-treatment
measure: Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores
timeFrame: Measurements for ILD pre-treatment and then at 6 months post-treatment
Locations:
city: Dallas
country: United States
facility: Lung Institute Dallas
state: Texas
Study officials:
affiliation: Lung Institute Dallas
name: Melissa Rubio, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References: