An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease

• ClinicalTrials.gov Identifier: NCT03040674
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: June 16, 2020
• Sponsor: Lung Institute
• Information provided by (Responsible Party): Melissa Rubio, PhD, APRN, Lung Institute

Tracking Information

• First Submitted Date: January 28, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: June 16, 2020
• Actual Study Start Date: January 3, 2017
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2017)

• Change in quality of life (QOL) from baseline [ Time Frame: Measurements pre-treatment then at 3 and 6 months post-treatment ]
  • Change from baseline in overall perceived quality of life over the course of a 12 month period as measured by the Clinical COPD Questionnaire (CCQ) The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ.
• Change in MMRC scale from baseline [ Time Frame: Measurements pre-treatment then at 3 and 6 months post-treatment ]
  • Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 6 months using the participant's self-reported response to the MMRC. Mean scores will be used at baseline (day 0) and at months 3 and 6.
• Change in FEV1 from baseline [ Time Frame: Measurements pre-treatment and at 6 months post-treatment ]
  •Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry. The change from baseline in FEV1 as measured by pulmonary function testing/spirometry over the course of 6 months. Scores will be used at baseline (day 0) and at 6 months.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
• Official Title: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease

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 same-day. Lung Institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are collected through venous harvesting.

The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their ability to be more physically active; walking greater distances with or without oxygen and improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability to reduce their use of oxygen and possibly to stop it., the ability to function well without the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

• Detailed Description: Through the collection of outcome data, Lung Institute aims to explore and describe the safety and efficacy of autologous cellular therapy 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, and to describe the anecdotal quality of life changes of patients following treatment using both quantitative and qualitative measures.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: The study population will include all patients treated with cell therapy at Lung Institute Dallas.

Condition

• COPD
• Interstitial Lung Disease

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

Study Groups/Cohorts

Cell therapy treated

All patients/participants enrolled will undergo cell therapy

Intervention: Procedure: Cell therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 15, 2020): 490
• Original Estimated Enrollment (submitted: January 31, 2017): 200
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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 nurse practitioner or physician of the Lung Institute who determines final eligibility for treatment. All eligible and thereby traded 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03040674
• Other Study ID Numbers: LI002 Cohort A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Melissa Rubio, PhD, APRN, Lung Institute
• Study Sponsor: Lung Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Melissa Rubio, PhD; Principal Investigator

• PRS Account: Lung Institute
• Verification Date: June 2020