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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell therapy treated | All patients/participants enrolled will undergo cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measurements for COPD pre-treatment and then at 3 months post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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The study population will include all patients treated with cell therapy Lung Institute in Dallas, Texas.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Rubio, PhD, APRN | Lung Institute Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lung Institute Dallas | Dallas | Texas | 75231 | United States |
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| Label | URL |
|---|---|
| Clinic webpage | View source |
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No patients in the study received placebo. All patients received autologous, adult stem cell therapy.
All patients who underwent elective, investigational cell therapy were enrolled in the outcomes study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who underwent cell therapy were included in the data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test. | Posted | Mean | Full Range | percentage of change in FEV1 | Measurements pre-treatment and then at 6 months post- treatment |
|
Adverse events monitoring and reporting was done over the entire length of the study, approximately 11 months from March 2016 through December 2016.
Any and all adverse events were reported to the Principal Investigator and reported to MaGil IRB and the supporting organization's quality and compliance monitor within 48 hours of the event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Surgical and medical procedures | Systematic Assessment | Participant reported dizziness following collection of blood sample for venous cell therapy. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Rubio, PhD, APRN | Lung Institute | 214-504-2117 | pidallas@lunginstitute.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 22, 2016 | Aug 24, 2017 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017563 | Lung Diseases, Interstitial |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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). |
| 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 | 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). | Measurements for ILD pre-treatment and then at 3 months post-treatment |
| 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). | Measurements for ILD pre-treatment and then at 6 months post-treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of Participants with Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Number of Participants with Interstitial Lung Disease (ILD) | Count of Participants | Participants |
|
| Treatment Type | Count of Participants | Participants |
|
| Baseline FEV1 if participant has COPD | 167 patients in the overall sample were diagnosed with chronic obstructive pulmonary disease (COPD). | Mean | Full Range | FEV1 Percentage (%) |
|
| Baseline Clinical COPD Questionnaire Score All Participants | The Clinical COPD Questionnaire (CCQ) is a 10-item scale where the participant chooses responses on a 0-6 scale for each item. 0 represents no symptoms and 6 represents severe symptoms. The mean of the responses is the final score and ranges from 0-6, 0 is least severe symptoms and 6 is most severe symptoms. | Mean | Full Range | units on a scale |
|
| COPD Participant Baseline QOL (quality of life) score based on the Clinical COPD Questionnaire (CCQ) | The Clinical COPD Questionnaire (CCQ) is a 10-item scale where the participant chooses responses on a 0-6 scale for each item. 0 represents no symptoms and 6 represents severe symptoms. The mean of the responses is the final score and ranges from 0-6, 0 is least severe symptoms and 6 is most severe symptoms. | 167 patients in the overall sample had a diagnosis of COPD. | Mean | Full Range | units on a scale |
|
| ILD Participant Baseline QOL score based on Clinical COPD Questionnaire (CCQ) | The Clinical COPD Questionnaire (CCQ) is a 10-item scale where the participant chooses responses on a 0-6 scale for each item. 0 represents no symptoms and 6 represents severe symptoms. The mean of the responses is the final score and ranges from 0-6, 0 is least severe symptoms and 6 is most severe symptoms. | 40 patients in the sample were diagnosed with interstitial lung disease (ILD) | Mean | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | 148 of 207 enrolled participants completed the 3 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements pre-treatment and then at 3 months post-treatment for all diagnoses |
|
|
|
| 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). | 124 patients completed a 6 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements pre-treatment and then at 6 months post-treatment among all diagnoses |
|
|
|
| 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). | 120 patients with COPD completed a 3 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements for COPD pre-treatment and then at 3 months post-treatment |
|
|
|
| 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). | 101 patients with COPD completed a 6 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements for COPD pre-treatment and then at 6 months post-treatment |
|
|
|
| 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). | 28 patients with ILD completed a 3 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements for ILD pre-treatment and then at 3 months post-treatment |
|
|
|
| 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). | 23 patients with ILD completed a 6 month post-treatment QOL survey | Posted | Count of Participants | Participants | Measurements for ILD pre-treatment and then at 6 months post-treatment |
|
|
|
| 4 |
| 207 |
| 0 |
| 207 |
| 10 |
| 207 |
|
| Bradycardia, not procedure related | Cardiac disorders | Bradycardia | Systematic Assessment | Participant presented with pre-treatment significant bradycardia and was transported to the emergency department for evaluation. Treatment protocol stopped pending evaluation. |
|
| Hypotension | Cardiac disorders | Hypotension | Systematic Assessment | Participants experienced low blood pressure following bone marrow harvesting of stem cells. Blood pressure was immediately corrected by the participant laying down and receiving intravenous fluids. |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |