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Completed

NCT Number: NCT03044431

Autologous Stem Cell Treatment for Chronic Lung Disease Study

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lung Institute Dallas

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cell Therapy

Procedure

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.

Primary outcomes

  1. Change in FEV1 From Baseline Among COPD Patients

    Time frame: Measurements pre-treatment and then at 6 months post- treatment

    Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment

  2. Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses

    Time frame: Measurements pre-treatment and then at 3 months post-treatment for 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).

  3. Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses

    Time frame: Measurements pre-treatment and then at 6 months post-treatment among 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).

Other outcomes

  1. Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores

    Time frame: Measurements for COPD pre-treatment and then at 3 months post-treatment

    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).

  2. Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores

    Time frame: Measurements for COPD pre-treatment and then at 6 months post-treatment

    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).

  3. Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores

    Time frame: Measurements for ILD pre-treatment and then at 3 months post-treatment

    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).

  4. Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores

    Time frame: Measurements for ILD pre-treatment and then at 6 months post-treatment

    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).

Sponsors and collaborators

Lead sponsor

Lung Institute

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2017
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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