Phase
Condition
Emphysema
Copd (Chronic Obstructive Pulmonary Disease)
Bronchitis
Treatment
Prochymal™
Placebo
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have a diagnosis of moderate or severe COPD.
Participant must have a post-bronchodilator FEV1/forced vital capacity (FVC) ratio < 0.7.
Participant must have a post-bronchodilator FEV1 % predicted value ≥ 30% and < 70%.
Participant must be between 40 and 80 years of age, of either sex, and of any race.
Participant must be a current or ex-smoker, with a cigarette smoking history of ≥ 10years or > 10 pack-years.
Exclusion
Exclusion Criteria:
Participant has been diagnosed with asthma or other clinically relevant lung diseaseother than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis,idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer).
Participant has been diagnosed with α1-antitrypsin deficiency.
Participant has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb).
Participant has active infection.
Participant has had a significant exacerbation of COPD or has required mechanicalventilation within 4 weeks of screening.
The participant with clinically relevant uncontrolled medical condition notassociated with COPD.
Participant has documented history of uncontrolled heart failure.
Participant has pulmonary hypertension due to left heart condition.
Participant has atrial fibrillation or significant congenital heart defect/disease.
Participant has initiated pulmonary rehabilitation within 3 months of screening.
Participant is allergic to bovine or porcine products.
Participant has evidence of active malignancy, or prior history of active malignancythat has not been in remission for at least 5 years.
Participant has a life expectancy of < 6 months.
Study Design
Study Description
Connect with a study center
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United StatesSite Not Available
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
American Health Research
Charlotte, North Carolina 28207
United StatesSite Not Available
Upstate Pharmaceutical Research
Greenville, South Carolina 29615
United StatesSite Not Available
Spartanburg Medical Research
Spartanburg, South Carolina 29303
United StatesSite Not Available
Vermont Lung Center, University of Vermont
Burlington, Vermont 05446
United StatesSite Not Available

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