Autologous Stem Cell Treatment for Chronic Lung Disease Study

• ClinicalTrials.gov Identifier: NCT03044431
• Recruitment Status: Completed
• First Posted: February 7, 2017
• Results First Posted: October 25, 2017
• Last Update Posted: October 15, 2018
• Sponsor: Lung Institute
• Information provided by (Responsible Party): Melissa Rubio, PhD, APRN, Lung Institute

Study Description

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.

Condition or disease	Intervention/treatment
COPD; Interstitial Lung Disease	Procedure: Cell therapy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 207 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Autologous Stem Cell Treatment for Chronic Lung Disease Study
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: June 1, 2017
• Actual Study Completion Date: June 9, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cell therapy treated; All patients/participants enrolled will undergo cell therapy	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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The study population will include all patients treated with cell therapy Lung Institute in Dallas, Texas.

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.

Contacts and Locations

Locations

United States, Texas

Lung Institute Dallas

Dallas, Texas, United States, 75231

Sponsors and Collaborators

Lung Institute

Investigators

• Principal Investigator: Melissa Rubio, PhD, APRN; Lung Institute Dallas

  Study Documents (Full-Text)

Documents provided by Melissa Rubio, PhD, APRN, Lung Institute:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] September 22, 2016

More Information

Additional Information:

Clinic webpage 

• Responsible Party: Melissa Rubio, PhD, APRN, PhD, APRN, Lung Institute
• ClinicalTrials.gov Identifier: NCT03044431
• Other Study ID Numbers: LI001
• First Posted: February 7, 2017
• Results First Posted: October 25, 2017
• Last Update Posted: October 15, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melissa Rubio, PhD, APRN, Lung Institute:

Shortness of breath; Breathlessness; Stem cells; Platelet rich plasma; Quality of life; Pulmonary Function

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Interstitial; Respiratory Tract Diseases