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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03044431
Other study ID # LI001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.


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Study Design


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
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