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

NCT03798353 | Completed Phase 1 DMC

• 2 other identifiers: ICOR-2016-022018-001964-49
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Cardiac repair; Wharton jelly mesenchymal stem cells; Chronic myocardial infarction; Tissue engineering; Cell therapy; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation.

  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.

  at 12 months of follow-up

Secondary Outcomes (10)

• Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation.

  At 1 week, 3 and 6 months

• Death rate or rehospitalization due to cardiovascular causes

  At 1 week, 3 , 6and 12 months

• Rate of relevant arrhythmias in Holter of 24 hours

  At 1 week, 3 and 12 months

• Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin I (hsTnI) levels

  At 1 week, 3 and 12 months

• Changes in the necrotic myocardial mass ratio

  At 3 and 12 months

Other Outcomes (1)

• monocyte populations and cytokines and chemokines levels

  At screening, day 3 and day 5

Study Arms (2)

Experimental group

EXPERIMENTAL

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 .

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

Control group

ACTIVE COMPARATOR

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

Procedure: Surgery by sternotomy

Interventions

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

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.

Experimental group

Surgery by sternotomy PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myocardial infarction of ≥50% of transmurally due to MR
• Candidate for coronary by-pass through that or another territory
• Age ≥18 years
• Signature of informed consent
• Wave Q present in the ECG
• Followed by the cardiology service of Germans Trial i Pujol hospital

You may not qualify if:

• 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
• Patients with a previous cardiac intervention
• Women who are pregnant or breast-feeding.
• 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).

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Antoni Bayes-Genís, MD, PhD,FESC

  Institut del Cor, HUGTiP, IGTP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: \- 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.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 9, 2019
• Study Start: May 13, 2019
• Primary Completion: September 27, 2022
• Study Completion: October 6, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

ES (1)