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Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT04047810
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Jorge M Mallea, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE January 6, 2020
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE 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)
Brief Summary Researchers are trying to understand the effects of mesenchymal stem cells therapy in subjects with advance chronic obstructive pulmonary disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Biological: Mesenchymal Stem Cells
0.5- 2 million cells/kg, intravenously once
Study Arms  ICMJE 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)
Intervention: Biological: Mesenchymal Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 16, 2021
Estimated Primary Completion Date August 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Starck 904-953-7971 starck.elizabeth@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04047810
Other Study ID Numbers  ICMJE 18-007748
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jorge M Mallea, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge M Mallea, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP