First cellularized collagen membrane implant to regenerate heart tissue in patients with ischemic heart disease
2 January, 2020 | General
3P Biopharmaceuticals and Viscofan go ahead with this innovative project of regenerative medicine for cardiac use.
3P Biopharmaceuticals, a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, and Viscofan BioEngineering, the Business Unit within the Viscofan Group), go one step further in an innovative cell therapy product.
Cardiomesh is the name of the project to develop and manufacture the VB-C01, an innovative biopharmaceutical drug owned by Viscofan, to treat patients with ischemic heart disease.
In fact, the first implantation of the combined drug VB-C01 has already been successfully performed in a patient with chronic heart failure of ischemic origin at the Gregorio Marañón Hospital in Madrid.
The treatment lies in placing a collagen membrane, in the patient’s heart affected area, similar to a patch, which contains allogeneic stem cells derived from adipose tissue (that are responsible for contributing to the regeneration of the infarcted tissue). In short, this is an Advanced Therapy Medicinal Product (ATMP).
This operation marks the beginning of the clinical trial whose goal is to evaluate the safety and tolerance of a new treatment for myocardial lesions in a group of 10 patients. This first part of the clinical development is being carried out at the Gregorio Marañón Hospital and the Clinic University of Navarra, which are contributing to the research of this innovative technique.
Dámaso Molero, 3P Biopharmaceuticals CEO, explained: “It’s exciting to be part of an innovative project in advanced cell therapy as Cardiomesh, which aims to treat heart failure patients and help improve their lives”.
The research to produce a regenerative therapy device is part of a Viscofan product diversification line aimed at the medical field, with collagen as the common denominator: “Our collagen membrane has unique properties that allow the implanted cells to remain active for longer in a highly manageable support“, explains Lluis Quintana, Director of the Bioengineering Unit at Viscofan.
The collaboration between both companies from Navarra began in 2015 with the process transfer to 3P Biopharmaceuticals after years of research at the University of Navarra and Viscofan BioEngineering. 3P Biopharmaceuticals, which has an exclusive area of cell therapy, carried out the implementation, the scaling-up, the validation and certification of the process under GMP conditions. Currently, 3P is responsible for manufacturing the drug VB-C01 for the clinical trial Phase I.
Ischemic cardiomyopathies, being part of the cardiovascular diseases and the main cause of death worldwide, account 33% of deaths in developed countries for people over 35’s.
In response, many palliative medical treatments have been developed, such as therapies with cardiac devices or heart transplants, which have reduced the number of deaths from acute myocardial infarctions. But at the same time, have contributed to an epidemic of chronic heart diseases of ischemic origin.
Therefore, the Cardiomesh project introduces, within the current paradigm of cardiovascular treatment, the development of regenerative therapy, through the manufacture of an industrial scale an advanced therapy product with unique properties.