Stav vývoje léku na COVID-19
Národní centrum tkání a buněk │ Primecell Advanced Therapy │ Informace o léčivém přípravku COV_19hUCTMSC (Remescor) pro ARDS COVID-19
The coronavirus disease 2019 (COVID-19) outbreak has now extended across the globe with >500,000 cases in 199 countries. The clinical spectrum of COVID-19 range widely from mild illness to ARDS with a high risk of mortality (3 to 16%). The virus affects primarily respiratory system leading to acute respiratory distress syndrome (ARDS) that required intubation in cases with serious or critical conditions.
PrimeCell Advanced Therapy is focused on contributing our knowledge and resources in regenerative medicine and somatocellular therapy to help patients and societies fighting COVID-19-associated ARDS. Our ATMP product (Remescor) could significantly improve critical care management of COVID-19-associated ARDS and resource planning.
Remescor is an Advanced therapy medicinal products (ATMP) developed for human use that is based on mesenchymal stromal cells isolated from umbilical cord (UC MSC). UC MSC offer groundbreaking new opportunities for the treatment of diseases involving immunological dysregulation and inflammation. According to European Medicinal Agency (EMA) somatic-cell therapy medicines these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body (cure, diagnose or prevent diseases). More…
Mesenchymal stromal cells in ARDS
- Stem Cell Trials Against COVID-19
- Clinical testing of MSC in ARDS
- Clinical testing of MSC in COPD
- Clinical testing of MSC in GVHD
- Top 60 Treatments in Development
Emergency Access to Remescor Outside of Clinical Trials
Enrollment in clinical trials is the primary way to access Remescor to generate critical data that inform the appropriate use of this investigational medicine. Emergency treatment requests are considered only when enrollment in a clinical trial is not a feasible option. PrimeCell is currently in the process of transitioning the provision of emergency access to Remescor for individual compassionate use requests. Primecell submited pharmaceutical documentation to SUKL 24. 3. 2020 to consider safety and efficacy of Remescor. An expanded access programs shall be developed based on evaluation of compassionate use for severely ill participating patients. These program is currently under rapid development in conjunction with national regulatory authorities.
- letter of NATIC to Ministerstvo zdravotnictví ČR a Ústřední krizový štáb
- Srovnání Remdesivir vs Remescor
1. § 49a Žádost o nemocniční výjimku pro léčivé přípravky pro moderní terapie; (https://www.zakonyprolidi.cz/cs/2007-378)
2. § 8 odst. 3 písm. b) bod 2 zákona o léčivech; (https://www.zakonyprolidi.cz/cs/2007-378)
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Poslední aktualizace: 26. 3. 2020