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Autologous Stem Cell Treatment for Chronic Lung Disease Study

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 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: COPD
Interstitial Lung Disease
Intervention: Procedure: Cell therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients who underwent elective, investigational cell therapy were enrolled in the outcomes study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients in the study received placebo. All patients received autologous, adult stem cell therapy.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Cell Therapy Treated
STARTED   207 
COMPLETED   148 
NOT COMPLETED   59 
Lost to Follow-up                59 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who underwent cell therapy were included in the data analysis.

Reporting Groups
  Description
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.


Baseline Measures
   Cell Therapy Treated 
Overall Participants Analyzed 
[Units: Participants]
 207 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 207 
<=18 years      0   0.0% 
Between 18 and 65 years      42  20.3% 
>=65 years      165  79.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 207 
Female      95  45.9% 
Male      112  54.1% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Number of Participants with Chronic Obstructive Pulmonary Disease (COPD) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 207 
   167 
Number of Participants with Interstitial Lung Disease (ILD) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 207 
   40 
Treatment Type 
[Units: Participants]
Count of Participants
 
Venous Protocol   
Participants Analyzed 
[Units: Participants]
 207 
Venous Protocol   159 
Double Venous Protocol   
Participants Analyzed 
[Units: Participants]
 207 
Double Venous Protocol   26 
Bone Marrow Protocol   
Participants Analyzed 
[Units: Participants]
 207 
Bone Marrow Protocol   22 
Baseline FEV1 if participant has COPD [1] 
[Units: FEV1 Percentage (%)]
Mean (Full Range)
 
Participants Analyzed 
[Units: Participants]
 167 
   36.9 
 (9 to 85) 
[1] 167 patients in the overall sample were diagnosed with chronic obstructive pulmonary disease (COPD).
Baseline Clinical COPD Questionnaire Score All Participants [1] 
[Units: Units on a scale]
Mean (Full Range)
 
Participants Analyzed 
[Units: Participants]
 207 
   3.6 
 (0.8 to 6.0) 
[1] 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.
COPD Participant Baseline QOL (quality of life) score based on the Clinical COPD Questionnaire (CCQ) [1] [2] 
[Units: Units on a scale]
Mean (Full Range)
 
Participants Analyzed 
[Units: Participants]
 167 
   3.6 
 (1.0 to 6.0) 
[1] 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] 167 patients in the overall sample had a diagnosis of COPD.
ILD Participant Baseline QOL score based on Clinical COPD Questionnaire (CCQ) [1] [2] 
[Units: Units on a scale]
Mean (Inter-Quartile Range)
 
Participants Analyzed 
[Units: Participants]
 40 
   3.3 
 (0.8 to 5.6) 
[1] 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] 40 patients in the sample were diagnosed with interstitial lung disease (ILD)


  Outcome Measures

1.  Primary:   Change in FEV1 From Baseline Among COPD Patients   [ Time Frame: Measurements pre-treatment and then at 6 months post- treatment ]

2.  Primary:   Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses   [ Time Frame: Measurements pre-treatment and then at 3 months post-treatment for all diagnoses ]

3.  Primary:   Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses   [ Time Frame: Measurements pre-treatment and then at 6 months post-treatment among all diagnoses ]

4.  Other Pre-specified:   Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores   [ Time Frame: Measurements for COPD pre-treatment and then at 3 months post-treatment ]

5.  Other Pre-specified:   Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores   [ Time Frame: Measurements for COPD pre-treatment and then at 6 months post-treatment ]

6.  Other Pre-specified:   Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores   [ Time Frame: Measurements for ILD pre-treatment and then at 3 months post-treatment ]

7.  Other Pre-specified:   Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores   [ Time Frame: Measurements for ILD pre-treatment and then at 6 months post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Melissa Rubio, PhD, APRN
Organization: Lung Institute
phone: 214-504-2117
e-mail: pidallas@lunginstitute.com



Responsible Party: Melissa Rubio, PhD, APRN, Lung Institute
ClinicalTrials.gov Identifier: NCT03044431     History of Changes
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 25, 2017