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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 same-day. Lung Institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are collected through venous harvesting.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell therapy treated | All patients/participants enrolled will undergo cell therapy |
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| 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 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. | 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. | 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. | Measurements pre-treatment and at 3 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all patients treated with cell therapy at Lung Institute Dallas.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Rubio, PhD | Principal Investigator | 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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All participants who started in the study were contacted at least twice at 3- and 6- months post-treatment by phone for quality of life follow-up. Participants were lost to follow-up at each time interval if they did not answer or return the call.
Participants were recruited from the clinic site in Dallas, Texas. Participants were all diagnosed with either COPD or interstitial lung disease by their personal pulmonologist. Records review by provider including diagnosis, past medical history, medications, labs from within 3 months, lung function test results and the participants' ability to travel to and from the treatment site were assessed prior to approval. This study is IRB approved and each participant signed Informed Consent.
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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 autologous cellular therapy with cells harvested either from peripheral blood or from bone marrow plus peripheral blood. After harvest, cells are processed using minimal manipulation for platelet-rich plasma/ platelet concentrate (from peripheral blood) and/or mesenchymal stem cells (from bone marrow) and returned to the patient via peripheral circulation on the same day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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489 participants were assessed at baseline
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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 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 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. | Posted | Mean | Standard Deviation | score on a scale | Measurements pre-treatment then at 3 and 6 months post-treatment |
|
Adverse event data were collected for up to 1 year for each participant.
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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 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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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Rubio, PhD, APRN | Lung Health Institute | 2145042117 | pidallas@thelunghealthinstitute.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2016 | Apr 26, 2021 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Mar 1, 2021 | ICF_002.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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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Chronic Lung Disease Diagnosis | Count of Participants | Participants |
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| Primary | 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. | 191 participants answered the MMRC questionnaire at baseline and again at 3-months post-treatment | Posted | Count of Participants | Participants | Measurements pre-treatment then at 3 months post-treatment |
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| Primary | 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. | 175 participants with COPD had pulmonary function measurements taken at baseline and at 3-months post-treatment. | Posted | Mean | Standard Deviation | percentage of predicted | Measurements pre-treatment and at 3 months post-treatment |
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| 23 |
| 489 |
| 0 |
| 489 |
| 0 |
| 489 |
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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 |
| MMRC Score 1 |
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| MMRC Score 2 |
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| MMRC Score 3 |
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| MMRC Score 4 |
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