Autologous Stem Cell Treatment for Chronic Lung Disease Study

NCT03044431 | Completed Results DMC

• 1 other identifier: LI001
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Interstitial Lung Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (4)

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

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

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

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

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

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

Study Arms (1)

Cell therapy treated

All patients/participants enrolled will undergo cell therapy

Procedure: Cell therapy

Interventions

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.

Cell therapy treated

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lung Institute: lead

Study Sites (1)

Lung Institute Dallas

Dallas, Texas, 75231, United States

Location

Related Links

• Clinic webpage

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Dyspnea

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Limitations and Caveats

This study is limited by a small sample size for post-treatment pulmonary function test returns and the self-reporting of quality of life scores. The CCQ measure quantifiable and can show trends over time, but it remains a subjective measure.

Results Point of Contact

• Title: Melissa Rubio, PhD, APRN
• Organization: Lung Institute

pidallas@lunginstitute.com

214-504-2117

Study Officials

• Melissa Rubio, PhD, APRN

  Lung Institute Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, APRN

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 9, 2017
• Last Updated: October 15, 2018
• Results First Posted: October 25, 2017

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)