- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04047810
Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)
March 21, 2024 updated by: Jorge M Mallea, Mayo Clinic
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- 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
- 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%.
Exclusion Criteria
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with Advanced Chronic Obstructive Pulmonary Disease
Subjects diagnosed with severe or very severe COPD will be infused intravenously with Mesenchymal Stem Cells (MSC)
|
0.5- 2 million cells/kg, intravenously once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: One hour post completion of infusion
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Number of subjects to tolerate IV infusion of Mesenchymal Stem Cells (MSC) without acute clinical or physiological deterioration
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One hour post completion of infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jorge M Mallea, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Actual)
November 21, 2023
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
August 5, 2019
First Posted (Actual)
August 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-007748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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