First cardiac bioimplants to treat patients with myocardial infarction with umbilical cord stem cells

The promising results obtained in the clinical trial with a pioneering advanced therapy drug called PeriCord, which seeks to repair the heart in patients who have suffered a heart attack, confirms the feasibility of new therapies based on the application of stem cells and tissue engineering to promote the regeneration of damaged tissues.

This new medicine, which comes from umbilical cord and pericardium stem cells from tissue donors, is a tissue engineering product (a type of advanced therapy that combines cells and tissues optimized in the laboratory), a pioneer worldwide and that It is applied in patients who are candidates for a coronary bypass, taking advantage of the intervention. Its function is to repair the scar that has been left in the area of ​​the heart affected by the heart attack, which has lost the ability to beat when the blood has stopped circulating.

The first intervention of this new therapy was almost 4 years ago as a result of the collaboration between the ICREC group (Heart Failure and Cardiac Regeneration) of the Germans Trias i Pujol Research Institute (IGTP) and the Banc de Sang i Teixits (BST), in Catalonia. Given the success, a study was initiated to demonstrate its clinical safety. The study included 12 patients who were candidates for coronary bypass, of which 7 were treated with bioimplants and 5 without, to compare the results.

“This pioneering clinical trial in humans comes after many years of research in tissue engineering, representing a very innovative and hopeful treatment for patients who have a scar on their heart as a result of having suffered a heart attack,” he declared, referring to the PeriCord, Dr. Antoni Bayés, researcher of the ICREC group and co-author of the study:

Although the current study was aimed at demonstrating the safety of this new drug in the setting of myocardial infarction, its good results have shown that PeriCord has other exceptional properties. On the one hand, it has proven to be a medicine with excellent biocompatibility, radically minimizing the risk of rejection and guaranteeing that the body tolerates it perfectly. And on the other hand, anti-inflammatory properties, which open the door to broader applications in pathologies where inflammation exists. “Its potential can be much broader, we believe it can be a very valuable tool to modulate inflammatory processes” explains Dr. Sergi Querol, head of the Cellular and Advanced Therapies Service at the BST.

ICREC-IGTP surgery team. (Photo: IGTP)

Severe but stable patients

Patients included in the therapy are people who have suffered a heart attack and have a reduced quality and life expectancy. On the one hand, the bypass ensures that there is blood supply to the area and, on the other hand, the bioimplant goes one step further to stimulate the scar and initiate the cellular mechanisms involved in tissue repair.

“Voluntarily donated substances of human origin are used, both in terms of multi-tissue donor pericardium tissue and umbilical cord donor mesenchymal stem cells in the birth of a baby,” explains Querol. It is very satisfying to think that “as a result of this and thanks to the donors, we provide a new therapeutic tool that can improve the patient's quality of life,” she adds.

The PeriCord is made up of a membrane that comes from the pericardium of a tissue donor, which the BST has decellularized and lyophilized. Afterwards, it has been recellularized with these umbilical cord stem cells.

Once in the operating room, the surgeons fix the bioimplant generated in the laboratory in the affected area of ​​the patient's heart. After a year, the implanted tissue adheres and adapts perfectly to the structure of the patient's heart, covering the scar left by the heart attack.

The study is titled “Implantation of a double allogeneic human engineered tissue graft on damaged heart: insights from the PERISCOPE phase I clinical trial.” And it has been published in the academic journal eBioMedicine. (Source: IGTP)