Overview

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