PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive P… (NCT00683722) | Clinical Trial Compass
CompletedPhase 2
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
United States62 participantsStarted 2008-03-20
Plain-language 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 to severe chronic obstructive pulmonary disease (COPD).
Who can participate
Age range40 Years – 80 Years
SexALL
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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 ≥ 10 years or \> 10 pack-years.
Exclusion Criteria:
* 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.
* Partici…