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

Last updated: March 9, 2026
Sponsor: Mesoblast, Inc.
Overall Status: Completed

Phase

2

Condition

Emphysema

Copd (Chronic Obstructive Pulmonary Disease)

Bronchitis

Treatment

Prochymal™

Placebo

Clinical Study ID

NCT00683722
801
  • Ages 40-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ≥ 10years or > 10 pack-years.

Exclusion

Exclusion Criteria:

  • Participant has been diagnosed with asthma or other clinically relevant lung diseaseother 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 mechanicalventilation within 4 weeks of screening.

  • The participant with clinically relevant uncontrolled medical condition notassociated 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 malignancythat has not been in remission for at least 5 years.

  • Participant has a life expectancy of < 6 months.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Prochymal™
Phase: 2
Study Start date:
March 20, 2008
Estimated Completion Date:
August 24, 2010

Study 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.

Connect with a study center

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • American Health Research

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Upstate Pharmaceutical Research

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Vermont Lung Center, University of Vermont

    Burlington, Vermont 05446
    United States

    Site Not Available

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