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History of Changes for Study: NCT00683722

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Latest version (submitted March 6, 2020) on ClinicalTrials.gov

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Study Record Versions

	Version	A	B	Submitted Date	Changes
1	1			May 21, 2008	None (earliest Version on record)
2	2			June 13, 2008	Contacts/Locations and Study Status
3	3			July 17, 2008	Contacts/Locations and Study Status
4	4			July 31, 2008	Recruitment Status, Contacts/Locations and Study Status
5	5			July 6, 2009	Outcome Measures and Study Status
6	6			August 24, 2010	Study Status
7	7			September 23, 2011	Recruitment Status, Study Status and Study Design
8	8			December 3, 2014	Sponsor/Collaborators, Study Status and Study Identification
9	9			March 6, 2020	Study Status, Outcome Measures, Arms and Interventions, Oversight, Sponsor/Collaborators and Contacts/Locations

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Changes (Merged) for Study: NCT00683722
Compare v7 to v8December 3, 2014 (v8) -- March 6, 2020 (v9)No more versions to compare

Changes in:Study Status,Outcome Measures,Arms and Interventions,Oversight,Sponsor/CollaboratorsandContacts/Locations

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Study Identification Unique Protocol ID: 801 Brief Title: PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Official Title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL™ (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Secondary IDs:

Study Status Record Verification: December 2014March 2020 Overall Status: Completed Study Start: April 2008May 20, 2008 Primary Completion: December 2010 [Actual]March 9, 2009 [Actual] Study Completion: DecemberAugust 24,2010 [Actual] First Submitted: May 21, 2008 First Submitted that Met QC Criteria: May 21, 2008 First Posted: May 23, 2008 [Estimate] Last Update Submitted that Met QC Criteria: December 3, 2014March 6, 2020 Last Update Posted: December 4March 10,20142020[Estimate]

Sponsor/Collaborators Sponsor: Mesoblast International SàrlMesoblast, Inc. Responsible Party: Sponsor Collaborators:

Oversight U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: No Data Monitoring:

Study Description Brief Summary: The objective of the present study is to establish the safety and efficacy of multiple administrations of PROCHYMAL™ (human adult stem cells) in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Detailed Description: 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 patients 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 FEV1 decline and COPD progression. In general patients 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.

Conditions Conditions: Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis Keywords: COPD Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease Chronic Obstructive Pulmonary Disease Pulmonary Emphysema Chronic Bronchitis Mesenchymal Stem Cells MSCs Adult Human Stem Cells Osiris Prochymal

Study Design Study Type: Interventional Primary Purpose: Treatment Study Phase: Phase 2 Interventional Study Model: Parallel Assignment Number of Arms: 2 Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Allocation: Randomized Enrollment: 62 [Actual]

Arms and Interventions Arms Assigned Interventions Experimental: AExperimental: PROCHYMAL™ PROCHYMAL™ Drug: PROCHYMAL™ Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells Other Names: Ex vivo cultured adult human mesenchymal stem cells Prochymal Placebo Comparator:BPlacebo Placebo Drug: Placebo Intravenous infusion of excipient of PROCHYMAL™

Outcome Measures Primary Outcome Measures: 1. SafetyNumber of Participants with Adverse Events (AEs) ThroughUp to2 Years Secondary Outcome Measures: 2. Pulmonary Function TestsChange from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 at Year 1 and Year 2 Through 1 yearBaseline, Year 1, Year 2 3. Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2 Baseline, Year 1, Year 2 4. Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2 Baseline, Year 1, Year 2 5. Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2 Baseline, Year 1, Year 2 6. Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume to Forced Vital Capacity Ratio (FEV1/FVC) at Year 1 and Year 2 Baseline, Year 1, Year 2 7. Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at Year 1 and Year 2 Baseline, Year 1, Year 2 8. Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) %predicted at Year 1 and Year 2 Baseline, Year 1, Year 2 9. Change from Baseline in Alveolar Volume (VA) at Year 1 and Year 2 Baseline, Year 1, Year 2 10. Change from Baseline in Diffusing capacity of the lung for carbon monoxide to Alveolar Volume ratio (DLCO/VA)at Year 1 and Year 2 Baseline, Year 1, Year 2 11. Change from Baseline in Functional residual capacity (FRC) at Month 6 Baseline, Month 6 12. Change from Baseline in Total Lung Capacity (TLC) at Month 6 Baseline, Month 6 13. Change from Baseline in Residual Volume (RV) at Month 6 Baseline, Month 6 14. Change from Baseline in Airway Resistance (RAW) at Month 6 Baseline, Month 6 15. 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] 16. Change from Baseline in Borg Dyspnea Scale at Year 2 Baseline, Year 2 17. Change from Baseline in Health-related quality of life: St George's Respiratory Questionnaire (SGRQ) at Year 1 and Year 2 Baseline, Year 1, Year 2 18. 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] 19. Time to COPD Exacerbation Up to 2 Years 20. Number of COPD Exacerbations Up to 2 Years 21. Change from Baseline in Pulmonary Hypertension at Month 6 Baseline, Month 6 22. 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] 23. Exercise Capability Through 1 year 24. Quality of life Through 1 year

Eligibility Minimum Age: 40 Years Maximum Age: 80 Years Sex: All Gender Based: Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Subject must have a diagnosis of moderate or severe COPD Subject must have a post-bronchodilator FEV1/FVC ratio < 0.7 Subject must have a post-bronchodilator FEV1 % predicted value ≥ 30% and < 70% Subject must be between 40 and 80 years of age, of either sex, and of any race Subject must be a current or ex-smoker, with a cigarette smoking history of ≥ 10 years or > 10 pack-years Exclusion Criteria: Subject has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer) Subject has been diagnosed with α1-Antitrypsin deficiency Subject has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb) Subject has active infection Subject has had a significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening Subject with clinically relevant uncontrolled medical condition not associated with COPD Subject has documented history of uncontrolled heart failure Subject has pulmonary hypertension due to left heart condition Subject has atrial fibrillation or significant congenital heart defect/disease Subject has initiated pulmonary rehabilitation within 3 months of screening Subject is allergic to bovine or porcine products Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years Subject has a life expectancy of < 6 months

Contacts/Locations Study Officials: Mahboob Rahman, MD Study Director Mesoblast, Inc. Locations: United States, California David Geffen School of Medicine at UCLA Los Angeles, California, United States, 90095 Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center Torrance, California, United States, 90502 United States, North Carolina American Health Research Charlotte, North Carolina, United States, 28207 United States, South Carolina Upstate Pharmaceutical Research Greenville, South Carolina, United States, 29615 Spartanburg Medical Research Spartanburg, South Carolina, United States, 29303 United States, Vermont Vermont Lung Center, University of Vermont Burlington, Vermont, United States, 05446

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References Citations: Links: Available IPD/Information:

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