The objective of the present study is to establish the safety and efficacy of multiple administrations of Prochymal™(ex-vivo cultured human adult mesenchymal stem cells) in participants with moderate to severe chronic obstructive pulmonary disease (COPD).
COPD is currently the fourth leading cause of death in the United States. It is clear that there is a significant unmet medical need for safe and effective therapies to treat moderate to severe COPD. This patient population has a high mortality rate and requires frequent hospitalizations due to disease-related exacerbations. Based on severity distribution estimates, approximately 70% of all current COPD patient have either moderate or severe COPD. COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. Oxygen therapy is the only treatment that has been shown to improve survival. Smoking cessation has been shown to slow the rate of forced expiratory volume in 1 second (FEV1) decline and COPD progression. In general patient are treated with bronchodilators and inhaled corticosteroids, but again, these measures do not provide any significant benefit regarding disease progression or prognosis. The characteristics and biologic activity of Prochymal™, along with a good safety profile in human trials to date, suggest that Prochymal™ may be a good candidate for addressing this unmet medical need.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
IV infusion of ex- vivo cultured adult human mesenchymal stem cells.
IV infusion of excipient of Prochymal™.
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, United States
American Health Research
Charlotte, North Carolina, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Number of Participants with Adverse Events (AEs)
Time frame: Up to 2 Years
Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume to Forced Vital Capacity Ratio (FEV1/FVC) at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) %predicted at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Alveolar Volume (VA) at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Diffusing capacity of the lung for carbon monoxide to Alveolar Volume ratio (DLCO/VA)at Year 1 and Year 2
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Spartanburg Medical Research
Spartanburg, South Carolina, United States
Vermont Lung Center, University of Vermont
Burlington, Vermont, United States
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Functional residual capacity (FRC) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in Total Lung Capacity (TLC) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in Residual Volume (RV) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in Airway Resistance (RAW) at Month 6
Time frame: Baseline, Month 6
Change from Baseline in 6-Minute Walk Test at Year 1 and Year 2
Change from baseline in the total distance walked in 6 minutes was reported.
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Borg Dyspnea Scale at Year 2
Time frame: Baseline, Year 2
Change from Baseline in Health-related quality of life: St George's Respiratory Questionnaire (SGRQ) at Year 1 and Year 2
Time frame: Baseline, Year 1, Year 2
Change from Baseline in Physician Global Assessment Scale at Year 1 and Year 2
The physician evaluated the subject's global status as improved, unchanged, or worsened from pretreatment.
Time frame: Baseline, Year 1, Year 2
Time to COPD Exacerbation
Time frame: Up to 2 Years
Number of COPD Exacerbations
Time frame: Up to 2 Years
Change from Baseline in Pulmonary Hypertension at Month 6
Time frame: Baseline, Month 6
Change from Baseline in Systemic Inflammation at Year 1 and Year 2
Changes in systemic inflammation was determined by C-Reactive Protein (CRP) assays.
Time frame: Baseline, Year 1 and Year 2