Pulmonary Disease, Chronic ObstructivePhase 2NCT00683722
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Prochymal™ in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Emphysema, run by Mesoblast, Inc. at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Chronic Bronchitis
- What is being tested?
- Prochymal™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Mar 2008to 24 Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Vermont Lung Center, University of Vermont
Burlington, Vermont, 05446
American Health Research
Charlotte, North Carolina, 28207
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502
About this study
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)
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).
Read the 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.
- Being tested
- Prochymal™, Placebo
- 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™
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochymal™Drug
IV infusion of ex- vivo cultured adult human mesenchymal stem cells.
PlaceboDrug
IV infusion of excipient of Prochymal™.
| Study group | Role | What they receive |
|---|---|---|
| Prochymal™ | Experimental | Participants received Prochymal™ a total of 400×10^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90. Receives: Drug: Prochymal™ |
| Placebo | Placebo comparator | Participants received placebo-matching IV infusions on Days 0, 30, 60 and 90. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: 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
Measured: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Expiratory Volume (FEV)1 %predicted at Year 1 and Year 2
Measured: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) at Year 1 and Year 2
Measured: Baseline, Year 1, Year 2
Change from Baseline in Pulmonary Function Test: Forced Vital Capacity (FVC) %predicted at Year 1 and Year 2
Measured: 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
Measured: Baseline, Year 1, Year 2
Change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at Year 1 and Year 2
Measured: 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
Measured: Baseline, Year 1, Year 2
Change from Baseline in Alveolar Volume (VA) at Year 1 and Year 2
Measured: 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
Measured: Baseline, Year 1, Year 2
Change from Baseline in Functional residual capacity (FRC) at Month 6
Measured: Baseline, Month 6
Change from Baseline in Total Lung Capacity (TLC) at Month 6
Measured: Baseline, Month 6
Change from Baseline in Residual Volume (RV) at Month 6
Measured: Baseline, Month 6
Change from Baseline in Airway Resistance (RAW) at Month 6
Measured: Baseline, Month 6
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.
Measured: Baseline, Year 1, Year 2
Change from Baseline in Borg Dyspnea Scale at Year 2
Measured: Baseline, Year 2
Change from Baseline in Health-related quality of life: St George's Respiratory Questionnaire (SGRQ) at Year 1 and Year 2
Measured: Baseline, Year 1, Year 2
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.
Measured: Baseline, Year 1, Year 2
Time to COPD Exacerbation
Measured: Up to 2 Years
Number of COPD Exacerbations
Measured: Up to 2 Years
Change from Baseline in Pulmonary Hypertension at Month 6
Measured: Baseline, Month 6
Change from Baseline in Systemic Inflammation at Year 1 and Year 2
Changes in systemic inflammation was determined by C-Reactive Protein (CRP) assays.
Measured: Baseline, Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study start20 Mar 2008
- Primary completion9 Mar 2009
- Study completion24 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher James, PA, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683722
- Sponsor's protocol ID
- 801
- Status last verified
- Nov 2025
- First submitted
- 21 May 2008
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33964910Weiss 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.
PubMed 23172272Gross NJ. The COPD Pipeline XIV. COPD. 2012 Feb;9(1):81-3. doi: 10.3109/15412555.2012.646587. No abstract available.
PubMed 22292600
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00683722
- Acronym / sponsor ID
- 801
- Keywords
- COPD, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema, Chronic Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2008 (actual)
- Primary completion
- 9 Mar 2009 (actual)
- Study completion
- 24 Aug 2010 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prochymal™ | Experimental | Drug: Prochymal™Participants received Prochymal™ a total of 400×10^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo-matching IV infusions on Days 0, 30, 60 and 90. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prochymal™IV infusion of ex- vivo cultured adult human mesenchymal stem cells. | Drug | Prochymal™ |
| PlaceboIV infusion of excipient of Prochymal™. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 2 Years
21 secondary outcomes
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 33964910Weiss 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.
- Derived from this study: PubMed 23172272Weiss 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.
- Derived from this study: PubMed 22292600Gross NJ. The COPD Pipeline XIV. COPD. 2012 Feb;9(1):81-3. doi: 10.3109/15412555.2012.646587. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher James, PA study director
Mesoblast, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prochymal™ in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Emphysema, run by Mesoblast, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.