Chronic Obstructive Pulmonary DiseasePhase 1NCT04047810
Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing Mesenchymal Stem Cells in people with Chronic Obstructive Pulmonary Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to understand the effects of mesenchymal stem cells therapy in subjects with advance chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 15 Aug 2025
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: at least 18 years of age
- Gender: Male or female
- Target disease or condition: Subjects with advance COPD
- Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
- Subject must have a post-bronchodilator FEV1percent predicted value between 20% and 49%.
- Subject must have a total lung capacity (TLC) percent predicted of 80% or more
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- Subject must be an ex-smoker, with a cigarette smoking history of ≥ 10 pack-years.
- Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.
- Subjects must score at least 2 in the modified Medical Research Council (mMRC)
- Subjects must have had an exacerbation of COPD within the last 12 months prior to enrollment in the study. An acute exacerbation of COPD is defined as a respiratory event requiring the use of antibiotics or systemic steroids or both.
- Informed consent form (ICF): Each patient will be required to sign an IRB approved ICF. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50.
- Subject must have a calculated creatinine clearance of greater than 30 ml/min.
- Subject must be available for all specified assessments at the study site through the completion of the study.
- Subject must provide written ICF and authorization for use of and disclosure of PHI.
- Subjects must have oxyhemoglobin saturation on room air at rest equal or greater than 88%.
Who cannot join
- Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the MSC infusion or complete the study
- Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
- Subject has been diagnosed with α1-Antitrypsin deficiency
- Subject has a body mass index greater than 35 or less than 16
- Subject has or has had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
- Subject has had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
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- Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study
- Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study
- Subject has evidence or history of malignancy
- Subject has evidence or history of autoimmune disorders independent of COPD
- Subject is pregnant or breast-feeding
- Subject has a history of HIV, Hepatitis B and/or Hepatitis C
- Subject has evidence of liver dysfunction manifested as alkaline phosphatase greater than 345 u/L, total bilirubin greater than 1.65 mg/dL, ALT greater than 275 units/L and/or AST great than 240 units/L.
- Subject has evidence of significant cardiac dysfunction, e.g. acute myocardial infarction within 3 months of screening, patients with the diagnosis of unstable angina. Patients with the diagnosis of "Cor pulmonale", uncontrolled tachyarrhythmia or bradyarrhythmia, atrial fibrillation or atrial flutter, history of insertion of pacemaker or implantable cardioverter-defibrillator, patient with clinical diagnose of heart failure with preserved or reduced ejection fraction and patients with a history of congenital heart disease.
- Subjects with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
- Subjects with clinically significant bronchiectasis.
- Subject received an experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment
- Subject is unable to complete all the testing required for the study
- Subjects who are on immunosuppressive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)
Researchers are trying to understand the effects of mesenchymal stem cells therapy in subjects with advance chronic obstructive pulmonary disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Mesenchymal Stem Cells
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsBiological
0.5- 2 million cells/kg, intravenously once
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Advanced Chronic Obstructive Pulmonary Disease | Experimental | Subjects diagnosed with severe or very severe COPD will be infused intravenously with Mesenchymal Stem Cells (MSC) Receives: Biological: Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of subjects to tolerate IV infusion of Mesenchymal Stem Cells (MSC) without acute clinical or physiological deterioration
Measured: One hour post completion of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start6 Jan 2020
- Primary completion21 Nov 2023
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge M Mallea, Mayo Clinic
- Investigators
- Jorge M Mallea, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047810
- Sponsor's protocol ID
- 18-007748
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2019
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04047810
- Acronym / sponsor ID
- 18-007748
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 7 Aug 2019 (actual)
- 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.
Researchers are trying to understand the effects of mesenchymal stem cells therapy in subjects with advance chronic obstructive pulmonary disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Advanced Chronic Obstructive Pulmonary Disease | Experimental | Biological: Mesenchymal Stem CellsSubjects diagnosed with severe or very severe COPD will be infused intravenously with Mesenchymal Stem Cells (MSC) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age range: at least 18 years of age
- Gender: Male or female
- Target disease or condition: Subjects with advance COPD
- Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
- Subject must have a post-bronchodilator FEV1percent predicted value between 20% and 49%.
Key exclusion criteria (19 listed)
- Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the MSC infusion or complete the study
- Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
- Subject has been diagnosed with α1-Antitrypsin deficiency
- Subject has a body mass index greater than 35 or less than 16
- Subject has or has had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
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 |
|---|---|---|
| Mesenchymal Stem Cells0.5- 2 million cells/kg, intravenously once | Biological | Subjects with Advanced Chronic Obstructive Pulmonary Disease |
Primary outcome
Adverse Events
Time frame: One hour post completion of infusion
Number of subjects to tolerate IV infusion of Mesenchymal Stem Cells (MSC) without acute clinical or physiological deterioration
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 14 Nov 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jorge M Mallea, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells in people with Chronic Obstructive Pulmonary Disease, run by Mayo Clinic at 1 site 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 15 inclusion and 19 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 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events (time frame: One hour post completion of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2025.