COPDNCT03040674

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

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.

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 same-day. Lung Institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (COPD) and interstitial… Read more about this study

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: 489 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2017to 31 Dec 2020
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 at Lung Institute Dallas.

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 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

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 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.

Read the 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.

Conditions: COPD, Interstitial Lung Disease
Being tested: Cell therapy
Keywords: Shortness of breath, Breathlessness, Cellular therapy, 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 NCT03040674
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 Quality of Life (QOL) From Baseline
- Change from baseline in overall perceived quality of life over the course of a 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60.
The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.
Measured: Measurements pre-treatment then at 3 and 6 months post-treatment
Change in MMRC Scale From Baseline
- Change from baseline in Modified Medical Research Council (MMRC) dyspnea scale The change from baseline in perceived level of dyspnea over the course of 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.
Measured: Measurements pre-treatment then at 3 months post-treatment
Change in FEV1 From Baseline
•Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry.
The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.
Measured: Measurements pre-treatment and at 3 months post-treatment

Timeline

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

3 Jan 201731 Dec 2020

First posted2 Feb 2017 (estimated)
Study start3 Jan 2017
Primary completion31 Dec 2020
Study completion31 Dec 2020

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: 489 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03040674
Sponsor's protocol ID: LI002 Cohort A
Status last verified: Apr 2021
First submitted: 28 Jan 2017
Last updated: 27 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
ClinicalTrials.gov ID: NCT03040674
Acronym / sponsor ID: LI002 Cohort A
Conditions: COPD, Interstitial Lung Disease
Keywords: Shortness of breath, Breathlessness, Cellular therapy, Platelet rich plasma, Quality of life, Pulmonary function
Study type: Observational
Recruitment status: Completed
Enrolment: 489 participants (actual)
Lead sponsor: Lung InstituteIndustry (pharma, biotech, devices)
Study start: 3 Jan 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 27 Apr 2021

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 at Lung Institute Dallas.

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 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

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 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 6 month period as measured by the Clinical COPD Questionnaire (CCQ). The CCQ is a 10-item questionnaire scored as 0-6 for each item (0 being never and 6 being all the time with higher scores representing worse quality of life). The total score is 0-60. The change from baseline over the course of 6 months using the participant's self-reported responses to the CCQ. Higher total values on the CCQ demonstrate worsening quality of life.
Change in MMRC Scale From Baseline
Time frame: Measurements pre-treatment then at 3 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 3 months using the participant's self-reported response to the MMRC. Possible scores are 0, 1, 2, 3 and 4 with higher scores representing severe loss of function due to breathing.
Change in FEV1 From Baseline
Time frame: Measurements pre-treatment and at 3 months post-treatment
•Change from baseline in FEV1 (COPD patients only) as measured by pulmonary function testing/spirometry. The change from baseline in FEV1% predicted as measured by pulmonary function testing/spirometry over the course of 3 months.

Results and safety

Results posted to the registry on 27 Apr 2021, 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	489	241

Primary outcome: Change in Quality of Life (QOL) From Baseline

Time frame: Measurements pre-treatment then at 3 and 6 months post-treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Cell Therapy Treated n = 489
Baseline CCQ Score	35.35 (10.56)
CCQ Score 3-Months Post-Treatment	27.96 (10.84)
CCQ Score 6 Months Post-Treatment	26.87 (10.84)

Primary outcome: Change in MMRC Scale From Baseline

Time frame: Measurements pre-treatment then at 3 months post-treatment. Count of participants. Unit: Participants

Measure	Cell Therapy Treated n = 191
MMRC Score 0: Baseline	3
MMRC Score 0: 3 Month Follow-Up	10
MMRC Score 1: Baseline	26
MMRC Score 1: 3 Month Follow-Up	31
MMRC Score 2: Baseline	32
MMRC Score 2: 3 Month Follow-Up	33
MMRC Score 3: Baseline	86
MMRC Score 3: 3 Month Follow-Up	93

Population analysed: 191 participants answered the MMRC questionnaire at baseline and again at 3-months post-treatment

Primary outcome: Change in FEV1 From Baseline

Time frame: Measurements pre-treatment and at 3 months post-treatment. Mean (Standard Deviation). Unit: percentage of predicted

Measure	Cell Therapy Treated n = 175
FEV1% Predicted at Baseline	34.2 (18.1)
FEV1% Predicted 3-Months Post-Treatment	35.8 (17.2)

Population analysed: 175 participants with COPD had pulmonary function measurements taken at baseline and at 3-months post-treatment.

Adverse events

Time frame: Adverse event data were collected for up to 1 year for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cell Therapy Treated	0 of 489 (0%)	0 of 489 (0%)	23 of 489

Limitations and caveats (from the sponsor): This study was an observational study only with no control (placebo) group and was designed to examine the outcomes of participants following cellular therapy. This study makes no comparison to placebo or any other treatment. Participants incurred the cost of treatment and travel to the treatment center. This study and treatment protocol was approved by Advarra IRB for Human Subjects Protection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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 principal investigator

Principal Investigator

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 27 Apr 2021. 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 27 Apr 2021). 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 Quality of Life (QOL) From Baseline (time frame: Measurements pre-treatment then at 3 and 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 NCT03040674.

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 27 Apr 2021.