Our own proprietary new technology for cllinical grade production of autologous mesenchymal and stromal stem cells (MSC) is currently translating into a clinical trial to prove its safety and efficacy in different therapies and clinical applications worldwide.
The Cell Factory, ESPERITE’s R&D Division, leads the expansion for clinical translation, commercialization of advanced cell therapy medicinal products, and development of new therapies in the field of regenerative medicine. Key activities include:
Product and process development activities support ESPERITE’s biobanking cord blood and cord tissue stem cells business and include Quality Control, Process Improvement, and Validation projects.
Proof-of-concept R&D projects for translation of the most promising developments in regenerative medicine from bench to the bedside.
Regenerative medicine translational projects include the implementation of the GLP and GMP compliant procedures and laboratories for preclinical development and clinical grade bioproduction, respectively. Also, the implementation of the GMP compliant bioproduction process of IMP (ATMP), the MSCs derived from frozen autologous cord tissue samples.
Our collaborations with leading academic, clinical and biotech partners on the development of new regenerative medicine products and services include projects with Ospedale Pediatrico Bambino Gesù, Rome (Vatican), Italy, and the Hospital Niño Jesús, Madrid, Spain (leading a multicentre clinical trial for investigation of new treatment of Cerebral Palsy).