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

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ClinicalTrials.gov Identifier: NCT00683722
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Tracking Information
First Submitted Date  ICMJE May 21, 2008
First Posted Date  ICMJE May 23, 2008
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE May 20, 2008
Actual Primary Completion Date March 9, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 2 Years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
  • Pulmonary Function Tests [ Time Frame: Through 1 year ]
  • Exercise capability [ Time Frame: Through 1 year ]
  • Quality of life [ Time Frame: Through 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume to Forced Vital Capacity Ratio (FEV1/FVC) at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) %predicted at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Alveolar Volume (VA) at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Diffusing capacity of the lung for carbon monoxide to Alveolar Volume ratio (DLCO/VA)at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Functional residual capacity (FRC) at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in Total Lung Capacity (TLC) at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in Residual Volume (RV) at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in Airway Resistance (RAW) at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in 6-Minute Walk Test at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
    Change from baseline in the total distance walked in 6 minutes was reported.
  • Change from Baseline in Borg Dyspnea Scale at Year 2 [ Time Frame: Baseline, Year 2 ]
  • Change from Baseline in Health-related quality of life: St George's Respiratory Questionnaire (SGRQ) at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
  • Change from Baseline in Physician Global Assessment Scale at Year 1 and Year 2 [ Time Frame: Baseline, Year 1, Year 2 ]
    The physician evaluated the subject's global status as improved, unchanged, or worsened from pretreatment.
  • Time to COPD Exacerbation [ Time Frame: Up to 2 Years ]
  • Number of COPD Exacerbations [ Time Frame: Up to 2 Years ]
  • Change from Baseline in Pulmonary Hypertension at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in Systemic Inflammation at Year 1 and Year 2 [ Time Frame: Baseline, Year 1 and Year 2 ]
    Changes in systemic inflammation was determined by C-Reactive Protein (CRP) assays.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
Safety [ Time Frame: Through 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Pulmonary Emphysema
  • Chronic Bronchitis
Intervention  ICMJE
  • Drug: PROCHYMAL™
    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
    Other Names:
    • Ex vivo cultured adult human mesenchymal stem cells
    • Prochymal
  • Drug: Placebo
    Intravenous infusion of excipient of PROCHYMAL™
Study Arms  ICMJE
  • Experimental: PROCHYMAL™
    PROCHYMAL™
    Intervention: Drug: PROCHYMAL™
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2011)
62
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2008)
60
Actual Study Completion Date  ICMJE August 24, 2010
Actual Primary Completion Date March 9, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00683722
Other Study ID Numbers  ICMJE 801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd. ( Mesoblast, Inc. )
Study Sponsor  ICMJE Mesoblast, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mahboob Rahman, MD Mesoblast, Inc.
PRS Account Mesoblast, Ltd.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP