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

• Status: Completed
• Trial end date: 2010-08-24
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast International Sàrl; Mesoblast, Inc.
• Treatments: Remestemcel-l

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