At the beginning of October the Polish Competent Authority, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products gave permission for conducting the BIOOPA clinical.
BIOOPA dressing is an advanced therapy investigational medicinal product, which is composed of Wharton’s Jelly delivered Mesenchymal Stem Cells seeded onto a natural matrix of decellularized allogeneic human skin scaffold.
This trial (phase I / II) is to evaluate the safety and efficiency of BIOOPA dressing in the treatment of wounds in the curse of Epidermolysis Bullosa, chronic venous leg ulceration, and thermal injury. The Sponsor of this non-commercial study is the Medical University of Warsaw as the BIOOPA Consortium Leader.
At Clinscience we proudly support Principal Investigators and creators of breakthrough therapies as BIOOPA. In this particular case, our Experts prepared the start-up of the study, helped in the medical writing, organization, management, and initiation of this important study.