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

Tracking Information
First Received Date ^ICMJE	May 21, 2008
Last Updated Date	July 6, 2009
Start Date ^ICMJE	April 2008
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 6, 2009)	Safety [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: May 21, 2008)	Quality of life [ Time Frame: Through 1 year ] [ Designated as safety issue: No ] 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 ]
Change History	Complete list of historical versions of study NCT00683722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 6, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: May 21, 2008)	Safety [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]

Descriptive Information
Brief Title ^ICMJE	PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title ^ICMJE	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)
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).
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis
Intervention ^ICMJE	Drug: PROCHYMAL™ Drug: Placebo
Study Arms / Comparison Groups	Experimental: PROCHYMAL™ Placebo Comparator: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Completion Date
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00683722
Responsible Party	Robin Flannery, Osiris Therapeutics, Inc.
Study ID Numbers ^ICMJE	801
Study Sponsor ^ICMJE	Osiris Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Osiris Therapeutics
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP