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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683722
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Brief 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).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis Drug: PROCHYMAL™ Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL™ (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: A
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Other Names:
  • Ex vivo cultured adult human mesenchymal stem cells
  • Prochymal

Placebo Comparator: B
Drug: Placebo
Intravenous infusion of excipient of PROCHYMAL™

Primary Outcome Measures :
  1. Safety [ Time Frame: Through 2 years ]

Secondary Outcome Measures :
  1. Pulmonary Function Tests [ Time Frame: Through 1 year ]
  2. Exercise Capability [ Time Frame: Through 1 year ]
  3. Quality of life [ Time Frame: Through 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683722

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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, United States, 90502
United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
United States, South Carolina
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Vermont
Vermont Lung Center, University of Vermont
Burlington, Vermont, United States, 05446
Sponsors and Collaborators
Mesoblast International Sàrl

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mesoblast International Sàrl Identifier: NCT00683722     History of Changes
Other Study ID Numbers: 801
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
Pulmonary Emphysema
Chronic Bronchitis
Mesenchymal Stem Cells
Adult Human Stem Cells
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections