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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Chronic Bronchitis

In brief

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).

Key facts

Study ID

NCT00683722

Run by

Mesoblast, Inc.

People needed

62

Starts

2008-03-20

Expected to finish

2010-08-24

Last updated by the study team

2026-03-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center — Torrance, California, United States
• American Health Research — Charlotte, North Carolina, United States
• Upstate Pharmaceutical Research — Greenville, South Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Vermont Lung Center, University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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