A Phase 2 interventional study of Prochymal™ and Placebo in Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema and Chronic Bronchitis, sponsored by Mesoblast, Inc.. Completed at 6 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Mesoblast, Inc. · Phase 2, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 62 is close to the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Mesoblast, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 4 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Prochymal™ a total of 400×10\^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90.
Drug: Prochymal™
Participants received placebo-matching IV infusions on Days 0, 30, 60 and 90.
Drug: Placebo
IV infusion of ex- vivo cultured adult human mesenchymal stem cells.
IV infusion of excipient of Prochymal™.
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
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
Ran from Mar 2008 to primary completion in Mar 2009, 11 months.
Of 118 industry-sponsored phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 11 months is below that.
Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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