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

NCT ID: NCT00683722

Last Updated: 2021-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-20
• Study Completion Date: 2010-08-24

Brief 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).

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 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.

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Chronic Bronchitis

Keywords

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™

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prochymal™

Participants received Prochymal™ a total of 400×10\^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90.

Group Type: EXPERIMENTAL

Prochymal™

Intervention Type: DRUG

IV infusion of ex- vivo cultured adult human mesenchymal stem cells.

Placebo

Participants received placebo-matching IV infusions on Days 0, 30, 60 and 90.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion of excipient of Prochymal™.

Interventions

Prochymal™

IV infusion of ex- vivo cultured adult human mesenchymal stem cells.

Intervention Type: DRUG

Placebo

IV infusion of excipient of Prochymal™.

Intervention Type: DRUG

Eligibility Criteria

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 α1-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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mesoblast, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahboob Rahman, MD

Role: STUDY_DIRECTOR

Mesoblast, Inc.

Locations

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, United States

American Health Research

Charlotte, North Carolina, United States

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Vermont Lung Center, University of Vermont

Burlington, Vermont, United States

Countries

United States

References

Weiss DJ, Segal K, Casaburi R, Hayes J, Tashkin D. Effect of mesenchymal stromal cell infusions on lung function in COPD patients with high CRP levels. Respir Res. 2021 May 8;22(1):142. doi: 10.1186/s12931-021-01734-8.

Reference Type: DERIVED

PMID: 33964910 (View on PubMed)

Weiss DJ, Casaburi R, Flannery R, LeRoux-Williams M, Tashkin DP. A placebo-controlled, randomized trial of mesenchymal stem cells in COPD. Chest. 2013 Jun;143(6):1590-1598. doi: 10.1378/chest.12-2094.

Reference Type: DERIVED

PMID: 23172272 (View on PubMed)

Gross NJ. The COPD Pipeline XIV. COPD. 2012 Feb;9(1):81-3. doi: 10.3109/15412555.2012.646587. No abstract available.

Reference Type: DERIVED

PMID: 22292600 (View on PubMed)

Other Identifiers

801

Identifier Type: -

Identifier Source: org_study_id