Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix.; Surgery by sternotomy
Intervention type(s): Combination Product; Procedure
Intervention description(s): 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.; 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.
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)
Primary purpose: Treatment
Keywords: Cardiac repair; Wharton jelly mesenchymal stem cells; Chronic myocardial infarction; Tissue engineering; Cell therapy; Clinical trial