COPDNCT03044431

Autologous Stem Cell Treatment for Chronic Lung Disease Study

An observational study of COPD and Interstitial Lung Disease, run by Lung Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: COPD, Interstitial Lung Disease
What is being tested?: Cell therapy
Type of treatment: Surgery or procedure
How many people: 207 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2016to 9 Jun 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lung Institute Dallas
Dallas, Texas, 75231

Other trials in United States

About this study

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.

Read the 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.

Conditions: COPD, Interstitial Lung Disease
Being tested: Cell therapy
Keywords: Shortness of breath, Breathlessness, Stem cells, Platelet rich plasma, Quality of life, Pulmonary Function
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cell therapyProcedure or surgery
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 in NCT03044431
Study group	Role	What they receive
Cell therapy treated		All patients/participants enrolled will undergo cell therapy Receives: Procedure: Cell therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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).
Measured: 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).
Measured: Measurements pre-treatment and then at 6 months post-treatment among all diagnoses

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20169 Jun 2017

First posted7 Feb 2017 (estimated)
Study start1 Apr 2016
Primary completion1 Jun 2017
Study completion9 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03044431
Sponsor's protocol ID: LI001
Status last verified: Oct 2018
First submitted: 3 Feb 2017
Last updated: 15 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous Stem Cell Treatment for Chronic Lung Disease Study
ClinicalTrials.gov ID: NCT03044431
Acronym / sponsor ID: LI001
Conditions: COPD, Interstitial Lung Disease
Keywords: Shortness of breath, Breathlessness, Stem cells, Platelet rich plasma, Quality of life, Pulmonary Function
Study type: Observational
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Lung InstituteIndustry (pharma, biotech, devices)
Study start: 1 Apr 2016 (actual)
Primary completion: 1 Jun 2017 (actual)
Study completion: 9 Jun 2017 (actual)
First posted: 7 Feb 2017 (estimated)
Results: Posted 25 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cell therapy treated	–	Procedure: Cell therapyAll patients/participants enrolled will undergo cell therapy

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study population will include all patients treated with cell therapy Lung Institute in Dallas, Texas.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cell therapyEach 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.	Procedure or surgery	Cell therapy treated

Primary outcome

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
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).
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).

Results and safety

Results posted to the registry on 25 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cell Therapy Treated	207	148

Primary outcome: Change in FEV1 From Baseline Among COPD Patients

Time frame: Measurements pre-treatment and then at 6 months post- treatment. Mean (Full Range). Unit: percentage of change in FEV1

Measure	Cell Therapy Treated n = 5
Value	12.8 (0 to 100)

Population analysed: All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Cell Therapy Treated n = 148
Value	121

Population analysed: 148 of 207 enrolled participants completed the 3 month post-treatment QOL survey

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Cell Therapy Treated n = 124
Value	90

Population analysed: 124 patients completed a 6 month post-treatment QOL survey

Adverse events

Time frame: Adverse events monitoring and reporting was done over the entire length of the study, approximately 11 months from March 2016 through December 2016.. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cell Therapy Treated	0 of 207 (0%)	10 of 207 (4.8%)	4 of 207

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinic webpageLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for COPD

Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Rubio, PhD, APRN principal investigator

Lung Institute Dallas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Interstitial Lung Disease, run by Lung Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FEV1 From Baseline Among COPD Patients (time frame: Measurements pre-treatment and then at 6 months post- treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03044431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.