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