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

NCT00683722 | Completed Phase 2 FDA Drug

• 1 other identifier: 801
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

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).

Conditions

Chronic Bronchitis; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema

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™

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  Up to 2 Years

Secondary Outcomes (21)

• Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 at Year 1 and Year 2

  Baseline, Year 1, Year 2

• Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2

  Baseline, Year 1, Year 2

• Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2

  Baseline, Year 1, Year 2

• Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2

  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

  Baseline, Year 1, Year 2

Study Arms (2)

Prochymal™

EXPERIMENTAL

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

Drug: Prochymal™

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Prochymal™ DRUG

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

Prochymal™

Placebo DRUG

IV infusion of excipient of Prochymal™.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesoblast, Inc.: lead

Study Sites (6)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Vermont Lung Center, University of Vermont

Burlington, Vermont, 05446, United States

Location

Related Publications (3)

• 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.

  PMID: 33964910 DERIVED

• 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.

  PMID: 23172272 DERIVED

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

  PMID: 22292600 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Bronchitis, Chronic

Interventions

remestemcel-l

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Christopher James, PA

  Mesoblast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: March 20, 2008
• Primary Completion: March 9, 2009
• Study Completion: August 24, 2010
• Last Updated: March 11, 2026

Record last verified: 2025-11

Locations

US (6)