COPD, Interstitial Lung Disease
Conditions
Keywords
Shortness of breath, Breathlessness, Stem cells, Platelet rich plasma, Quality of life, Pulmonary Function
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.
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.
Interventions
PROCEDURECell 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.
Sponsors
Lung Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1 From Baseline Among COPD Patients | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores | 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). |
| 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 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). |
| 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 | 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). |
Countries
United States
Participant flow
Recruitment details
All patients who underwent elective, investigational cell therapy were enrolled in the outcomes study.
Pre-assignment details
No patients in the study received placebo. All patients received autologous, adult stem cell therapy.
Participants by arm
| Arm | Count |
|---|---|
| Cell Therapy Treated All patients/participants enrolled will undergo cell therapy
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. | 207 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 59 |
Baseline characteristics
| Characteristic | Cell Therapy Treated | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 165 Participants | — |
| Age, Categorical Between 18 and 65 years | 42 Participants | — |
| Baseline Clinical COPD Questionnaire Score All Participants | 3.6 units on a scale | — |
| Baseline FEV1 if participant has COPD | 36.9 FEV1 Percentage (%) | — |
| COPD Participant Baseline QOL (quality of life) score based on the Clinical COPD Questionnaire (CCQ) | 3.6 units on a scale | — |
| ILD Participant Baseline QOL score based on Clinical COPD Questionnaire (CCQ) | 3.3 units on a scale | — |
| Number of Participants with Chronic Obstructive Pulmonary Disease (COPD) | 167 Participants | — |
| Number of Participants with Interstitial Lung Disease (ILD) | 40 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 95 Participants | — |
| Sex: Female, Male Male | 112 Participants | — |
| Treatment Type Bone Marrow Protocol | 22 Participants | — |
| Treatment Type Double Venous Protocol | 26 Participants | — |
| Treatment Type Venous Protocol | 159 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 207 |
| other Total, other adverse events | 10 / 207 |
| serious Total, serious adverse events | 0 / 207 |
Outcome results
Primary
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
Time frame: Measurements pre-treatment and then at 6 months post- treatment
Population: All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cell Therapy Treated | Change in FEV1 From Baseline Among COPD Patients | 12.8 percentage of change in FEV1 |
Primary
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).
Time frame: Measurements pre-treatment and then at 3 months post-treatment for all diagnoses
Population: 148 of 207 enrolled participants completed the 3 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses | 121 Participants |
Primary
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).
Time frame: Measurements pre-treatment and then at 6 months post-treatment among all diagnoses
Population: 124 patients completed a 6 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses | 90 Participants |
Other Pre-specified
Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores
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).
Time frame: Measurements for COPD pre-treatment and then at 3 months post-treatment
Population: 120 patients with COPD completed a 3 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores | 102 Participants |
Other Pre-specified
Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores
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).
Time frame: Measurements for COPD pre-treatment and then at 6 months post-treatment
Population: 101 patients with COPD completed a 6 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores | 79 Participants |
Other Pre-specified
Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores
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).
Time frame: Measurements for ILD pre-treatment and then at 3 months post-treatment
Population: 28 patients with ILD completed a 3 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores | 20 Participants |
Other Pre-specified
Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores
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).
Time frame: Measurements for ILD pre-treatment and then at 6 months post-treatment
Population: 23 patients with ILD completed a 6 month post-treatment QOL survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cell Therapy Treated | Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores | 13 Participants |