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

Sponsor:	Osiris Therapeutics
Information provided by:	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00683722

Purpose

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	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis	Drug: PROCHYMAL™ Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Chronic Bronchitis Emphysema

U.S. FDA Resources

Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:

Safety [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pulmonary Function Tests [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
Exercise Capability [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]

Enrollment:	62
Study Start Date:	April 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A PROCHYMAL™	Drug: PROCHYMAL™ 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 Placebo	Drug: Placebo Intravenous infusion of excipient of PROCHYMAL™

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683722

Locations

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

Osiris Therapeutics

More Information

No publications provided

Responsible Party:	Robin Flannery, Osiris Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00683722 History of Changes
Other Study ID Numbers:	801
Study First Received:	May 21, 2008
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:

COPD
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
MSCs
Adult Human Stem Cells
Osiris
Prochymal

Additional relevant MeSH terms:

Bronchitis
Bronchitis, Chronic
Chronic Disease
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012