Autologous Stem Cell Treatment for Chronic Lung Disease Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03044431 |
Recruitment Status :
Completed
First Posted : February 7, 2017
Results First Posted : October 25, 2017
Last Update Posted : October 15, 2018
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Study Type | Observational |
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Study Design | Observational Model: Cohort; Time Perspective: Prospective |
Conditions |
COPD Interstitial Lung Disease |
Intervention |
Procedure: Cell therapy |
Enrollment | 207 |
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. |
Arm/Group Title | Cell Therapy Treated |
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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. |
Period Title: Overall Study | |
Started | 207 |
Completed | 148 |
Not Completed | 59 |
Reason Not Completed | |
Lost to Follow-up | 59 |
Arm/Group Title | Cell Therapy Treated | |
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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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Overall Number of Baseline Participants | 207 | |
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All patients who underwent cell therapy were included in the data analysis.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 207 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
42 20.3%
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>=65 years |
165 79.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 207 participants | |
Female |
95 45.9%
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Male |
112 54.1%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | |
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Number of Participants with Chronic Obstructive Pulmonary Disease (COPD)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 207 participants | |
167 80.7%
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Number of Participants with Interstitial Lung Disease (ILD)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 207 participants | |
40 19.3%
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Treatment Type
Measure Type: Count of Participants Unit of measure: Participants |
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Venous Protocol | Number Analyzed | 207 participants |
159 76.8%
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Double Venous Protocol | Number Analyzed | 207 participants |
26 12.6%
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Bone Marrow Protocol | Number Analyzed | 207 participants |
22 10.6%
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Baseline FEV1 if participant has COPD
[1] Mean (Full Range) Unit of measure: FEV1 Percentage (%) |
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Number Analyzed | 167 participants | |
36.9
(9 to 85)
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[1]
Measure Analysis Population Description: 167 patients in the overall sample were diagnosed with chronic obstructive pulmonary disease (COPD).
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Baseline Clinical COPD Questionnaire Score All Participants
[1] Mean (Full Range) Unit of measure: Units on a scale |
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Number Analyzed | 207 participants | |
3.6
(0.8 to 6.0)
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[1]
Measure Description: 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.
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COPD Participant Baseline QOL (quality of life) score based on the Clinical COPD Questionnaire (CCQ)
[1] [2] Mean (Full Range) Unit of measure: Units on a scale |
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Number Analyzed | 167 participants | |
3.6
(1.0 to 6.0)
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[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 167 patients in the overall sample had a diagnosis of COPD.
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ILD Participant Baseline QOL score based on Clinical COPD Questionnaire (CCQ)
[1] [2] Mean (Inter-Quartile Range) Unit of measure: Units on a scale |
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Number Analyzed | 40 participants | |
3.3
(0.8 to 5.6)
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[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: 40 patients in the sample were diagnosed with interstitial lung disease (ILD)
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Name/Title: | Melissa Rubio, PhD, APRN |
Organization: | Lung Institute |
Phone: | 214-504-2117 |
EMail: | pidallas@lunginstitute.com |
Responsible Party: | Melissa Rubio, PhD, APRN, Lung Institute |
ClinicalTrials.gov Identifier: | NCT03044431 |
Other Study ID Numbers: |
LI001 |
First Submitted: | February 3, 2017 |
First Posted: | February 7, 2017 |
Results First Submitted: | June 27, 2017 |
Results First Posted: | October 25, 2017 |
Last Update Posted: | October 15, 2018 |