Status:
COMPLETED
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Mesoblast, Inc.
Conditions:
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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 ≥ 10 years or \> 10 pack-years.
Exclusion
- Participant 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).
- 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 mechanical ventilation within 4 weeks of screening.
- The participant with clinically relevant uncontrolled medical condition not associated 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 malignancy that has not been in remission for at least 5 years.
- Participant has a life expectancy of \< 6 months.
Key Trial Info
Start Date :
March 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00683722
Start Date
March 20 2008
End Date
August 24 2010
Last Update
December 23 2021
Active Locations (6)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, United States, 90502
3
American Health Research
Charlotte, North Carolina, United States, 28207
4
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615