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Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue (PERISCOPE)

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ClinicalTrials.gov Identifier: NCT03798353
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
Fundació Institut Germans Trias i Pujol

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. [ Time Frame: at 12 months of follow-up ]
Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03798353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. [ Time Frame: At 1 week, 3 and 6 months ]
    Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment
  • Death rate or rehospitalization due to cardiovascular causes [ Time Frame: At 1 week, 3 , 6and 12 months ]
    Death rate or rehospitalization due to cardiovascular causes at week, 3, 6 and 12 months.
  • Rate of relevant arrhythmias in Holter of 24 hours [ Time Frame: At 1 week, 3 and 12 months ]
    Rate of relevant arrhythmias in Holter of 24 hours a week, 3 and 12 months.
  • Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin T (hsTnT) levels [ Time Frame: At 1 week, 3 and 12 months ]
    Relevant changes in NT-proBNP and hsTnT levels at week, 3 and 12 months.
  • Changes in the necrotic myocardial mass ratio [ Time Frame: At 3 and 12 months ]
    Changes in the necrotic myocardial mass ratio due to gadolinium retention at 3 and 12 months.
  • Changes of regional contractility [ Time Frame: At 3 and 12 months ]
    change of regional contractility by nuclear magnetic resonance (NMR) at 3 and 12 months.
  • Changes in ejection fraction of the left ventricle [ Time Frame: At 3 and 12 months ]
    Changes in ejection fraction of the left at 3 and 12 months
  • changes in left and right ventricular geometric remodeling [ Time Frame: At 3 and 12 months ]
    changes in left and right ventricular geometric remodeling at 3 and 12 months
  • changes in the scores on the Kansas City Questionnaire quality of life test (KCCQ) [ Time Frame: At 3 and 12 months ]
    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function,symptoms (frequency,severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity,reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to range of 0-100, in which higher scores reflect better health status.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. [ Time Frame: At 1 week, 3 and 6 months ]
    Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment
  • Death rate or rehospitalization due to cardiovascular causes [ Time Frame: At 1 week, 3 , 6and 12 months ]
    Death rate or rehospitalization due to cardiovascular causes at week, 3, 6 and 12 months.
  • Rate of relevant arrhythmias in Holter of 24 hours [ Time Frame: At 1 week, 3 and 12 months ]
    Rate of relevant arrhythmias in Holter of 24 hours a week, 3 and 12 months.
  • Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin T (hsTnT) levels [ Time Frame: At 1 week, 3 and 12 months ]
    Relevant changes in NT-proBNP and hsTnT levels at week, 3 and 12 months.
  • Changes in the necrotic myocardial mass ratio [ Time Frame: At 3 and 12 months ]
    Changes in the necrotic myocardial mass ratio due to gadolinium retention at 3 and 12 months.
  • Changes of regional contractility [ Time Frame: At 3 and 12 months ]
    Change of regional contractility by nuclear magnetic resonance (NMR) at 3 and 12 months
  • Changes in ejection fraction of the left ventricle [ Time Frame: At 3 and 12 months ]
    Changes in ejection fraction of the left ventricle at 3 and 12 months.
  • changes in left and right ventricular geometric remodeling [ Time Frame: At 3 and 12 months ]
    Changes in left and right ventricular geometric remodeling at 3 and 12 months.
  • Changes in the scores on the Kansas City Questionnaire quality of life test (KCCQ). [ Time Frame: At 3 and 12 months ]
    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function,symptoms (frequency,severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2019)
monocyte populations and cytokines and chemokines levels [ Time Frame: At screening, day 3 and day 5 ]
changes in the monocyte populations and cytokines and chemokines levels between the two groups in order to analyze if the PeriCord could improve these variables
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue
Official Title  ICMJE Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue (The PERISCOPE Trial)
Brief Summary

Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today, there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and in more advanced stages the only therapy that completely restores cardiac function is heart transplantation.

Mesenchymal stem cells are multipotent cells found from embryonic mesoderm and found in all tissues. In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. Our approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.

Detailed Description

Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and, in more advanced stages, the only therapy that completely restores cardiac function is heart transplantation.

Experimental studies are evaluating new therapeutic approaches based on tissue engineering for myocardial regeneration. Cardiac tissue engineering attempts to create functional tissue constructs that can restore the structure and function of damaged myocardium.

Mesenchymal stem cells (MSCs) are multipotent cells that develop from embryonic mesoderm and are found in all structural tissues of the body.

In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. The investigators approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.

Among the different types of MSC currently available, the investigators propose the use of those derived from the connective tissue surrounding the great vessels (2 arteries and one vein) of the umbilical cord called Wharton's gelatin (MSC, WJ) whose immunomodulatory properties are described extensively in the literature. These MSC, WJ cells have a PEI approved by the Spanish Agency for Medicines and Healthcare Products (AEMPS) (PEI 16-017) that guarantees an optimal manufacturing process for a clinical trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

- Experimental group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.

In addition, the matrix-cell construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue.

- Control group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed.

Masking: Double (Participant, Investigator)
Masking Description:
The randomization will be known exclusively by the cardiac surgery team and the study coordinator, and it will be blind to the patient and to the rest of the investigators team: clinical cardiologist who performs the follow-up, team that performs image tests, core lab that evaluates the imaging tests and the equipment that statistically analyzes the data.
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Combination Product: PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix.
    A matrix-cell construct (PeriCord) will be placed on the ischemic area of the non-candidate revascularization area during a surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.
  • Procedure: Surgery by sternotomy
    The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed only the by-pass.
Study Arms  ICMJE
  • Experimental: Experimental group

    The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.

    In addition, the matrix-cell (PeriCord) construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue.

    PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix .

    Intervention: Combination Product: PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix.
  • Active Comparator: Control group
    The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed.
    Intervention: Procedure: Surgery by sternotomy
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: May 23, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2019)
10
Estimated Study Completion Date  ICMJE May 13, 2021
Estimated Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Myocardial infarction of ≥50% of transmurally due to nuclear magnetic resonance not eligible for revascularization due to transmurality or disease-vessel (defined as that with diffuse atherosclerosis or multiple lesions in tandem, with a diameter less than or equal to 1mm) or occluded artery.
  • Candidate for coronary by-pass for other territories than non-revascularize infarction.
  • Age ≥18 years
  • Signature of informed consent
  • Wave Q present in the ECG
  • Followed by the cardiology service of Germans Trial i Pujol hospital

Exclusion Criteria:

  • Severe valvular disease with indication of surgical repair
  • Candidate for ventricular remodeling
  • Contraindication for MR (creatinine clearance less than 30 ml / min / 1.73m2, metallic implant carriers, claustrophobia)
  • Extracardiac disease with estimated life expectancy less than 1 year
  • Neoplastic disease detected in the last five years or without complete remission
  • Severe renal or hepatic insufficiency
  • Abnormal laboratory values, not explainable at the time of inclusion, and that at the discretion of the investigator contraindicate the patient's participation in the study
  • Patients with a previous cardiac intervention
  • Women who are pregnant or breast-feeding.
  • Women of childbearing age who are heterosexually active and who do not use an effective contraceptive method from 14 days before the inclusion in the study and at least up to 12 weeks after the end of the study.
  • Simultaneous participation in another clinical trial or treatment with another product in investigational phase in the 30 days prior to inclusion in the study.
  • Negation of the patient to be followed by a period that exceeds the clinical trial itself (long-term follow-up in the second and third year).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoni Bayes-Genís, MD, PhD,FESC +34 93 497 86 62 abayesgenis@gmail.com
Contact: Paloma Gastelurrutia, PhD +34 93 497 8670 pgastelurrutia@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03798353
Other Study ID Numbers  ICMJE ICOR-2016-02
2018-001964-49 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Institut Germans Trias i Pujol
Study Sponsor  ICMJE Fundació Institut Germans Trias i Pujol
Collaborators  ICMJE Germans Trias i Pujol Hospital
Investigators  ICMJE
Principal Investigator: Antoni Bayes-Genís, MD, PhD,FESC Institut del Cor, HUGTiP, IGTP
PRS Account Fundació Institut Germans Trias i Pujol
Verification Date June 2019

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