Periodic Reporting for period 3 - TETUS (Tissue-engineered oral mucosa cells for treatment of urethral strictures)
Okres sprawozdawczy: 2020-08-01 do 2021-07-31
MukoCell® is the first and only tissue-engineered Advanced Therapeutic Medicinal Product (ATMP) for treatment of urethral strictures in the world. MukoCell®-Therapy at its current stage decreases the number of necessary surgeries to one (no need to obtain native tissue from the mouth in case of Urethroplasty) and decreases the chance of recurrence (associated with Urethrotomy).
The overall objective of the project is to valid MukoCell® in clinical environment and demonstrate its superiority and benefits compared to the Standard of Care and to make it ready for launch in the European markets by performing a market replication.
The exiting quality attributes of the product was submitted formally to PEI and additional required quality attributes were discussed in a meeting and the periodic quality report was submitted. In a product safety report the side effects and complications in 200 patients was submitted to PEI. Due to the absence of major side effects, the product was considered to be correspondingly safe. The transfer of the production line to the new subcontractor, CODON AG, is in process.To validate the product, 14 clinics from three different countries are recruited into a randomised pivotal clinical study. Positive opinion from the Ethics Committee of the Principal Investigator in Germany is obtained, and the application is submitted to the responsible Italian and Swiss agencies.