Autologous Stem Cell Treatment for Chronic Lung Disease Study

COPD Clinical Trial

Official title:

Autologous Stem Cell Treatment for Chronic Lung Disease Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044431
• Other study ID #: LI001
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: June 9, 2017

Study information

• Verified date: October 2018
• Source: Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• COPD
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Cell therapy
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.

Locations

Country	Name	City	State
United States	Lung Institute Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lung Institute

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Clinic webpage