Periodic Reporting for period 3 - TETUS (Tissue-engineered oral mucosa cells for treatment of urethral strictures)
Berichtszeitraum: 2020-08-01 bis 2021-07-31
Urethral stricture is a relatively common disease and an unmet medical need with an associated prevalence of about 200-600 cases per 100,000 males in Europe. Recurrent urethral stricture is a common secondary disease and affects 30% to 90% of suffering patient population depending on the treatment performed for the first time (the chances of recurrence increase by time). The conventional methods are completely incapable of alleviating Recurrent urethral stricture .
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.
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.
In the first year of the project the clinical partners were aquired and signed into the cooperation agreement. The positive opinion of the ethical committee was obtained and a S1 Laboratory was set up to fulfill the requirements of EMA for product safety and quality as the study medication. In parallel, the project was communicated to the public audience and the professionals to make them aware of the benefits of the MukoCell. To make the product available to the market reimbursement was negotiated with public and private insurance companies and obtained the support of two private insurance companies to reimburse treatment with MukoCell.
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.
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.
It is expected that by the end of this project, MukoCell is ready to reach a Technologly Readiness Level of 7 and to be prepared for clinical product validation and qualification.