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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683722
• Other study ID #: 801
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2008
• Est. completion date: August 24, 2010

Study information

• Verified date: December 2021
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 patient 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 forced expiratory volume in 1 second (FEV1) decline and COPD progression. In general patient 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 24, 2010
• Est. primary completion date: March 9, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 a1-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.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Drug:
• Prochymal™
IV infusion of ex- vivo cultured adult human mesenchymal stem cells.
• Placebo
IV infusion of excipient of Prochymal™.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Up to 2 Years
Secondary	Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume to Forced Vital Capacity Ratio (FEV1/FVC) at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) %predicted at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Alveolar Volume (VA) at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Diffusing capacity of the lung for carbon monoxide to Alveolar Volume ratio (DLCO/VA)at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Functional residual capacity (FRC) at Month 6		Baseline, Month 6
Secondary	Change from Baseline in Total Lung Capacity (TLC) at Month 6		Baseline, Month 6
Secondary	Change from Baseline in Residual Volume (RV) at Month 6		Baseline, Month 6
Secondary	Change from Baseline in Airway Resistance (RAW) at Month 6		Baseline, Month 6
Secondary	Change from Baseline in 6-Minute Walk Test at Year 1 and Year 2	Change from baseline in the total distance walked in 6 minutes was reported.	Baseline, Year 1, Year 2
Secondary	Change from Baseline in Borg Dyspnea Scale at Year 2		Baseline, Year 2
Secondary	Change from Baseline in Health-related quality of life: St George's Respiratory Questionnaire (SGRQ) at Year 1 and Year 2		Baseline, Year 1, Year 2
Secondary	Change from Baseline in Physician Global Assessment Scale at Year 1 and Year 2	The physician evaluated the subject's global status as improved, unchanged, or worsened from pretreatment.	Baseline, Year 1, Year 2
Secondary	Time to COPD Exacerbation		Up to 2 Years
Secondary	Number of COPD Exacerbations		Up to 2 Years
Secondary	Change from Baseline in Pulmonary Hypertension at Month 6		Baseline, Month 6
Secondary	Change from Baseline in Systemic Inflammation at Year 1 and Year 2	Changes in systemic inflammation was determined by C-Reactive Protein (CRP) assays.	Baseline, Year 1 and Year 2