About us
As part of Translational Research Platform for Regenerative Medicine MMRI PAS, a unique laboratory has been established and its team is responsible for the implementation of innovative, potential cell therapies for clinical research.
The employees of the Platform are divided in two teams which operate in close collaboration. The research team provides preclinical research facilities and conducts pilot studies using their long experience and current knowledge in clinical application of cells of regenerative potential. Laboratory team, in turn, working in line with Good Manufacturing Practice (GMP) is accountable for the transfer of designed technologies to clinical applications.
Specialist Team
general email address: This email address is being protected from spambots. You need JavaScript enabled to view it.
Aleksandra Dominiak M.Sc., phone: 22 60 86 637; This email address is being protected from spambots. You need JavaScript enabled to view it.
Katarzyna Gąsowska M.Sc., phone 22 60 86 504; This email address is being protected from spambots. You need JavaScript enabled to view it.
Daniel Szopa M.Sc., phone: 22 60 86 504; This email address is being protected from spambots. You need JavaScript enabled to view it.
Katarzyna Jezierska-Woźniak Ph.D., phone 89 524 53 38, This email address is being protected from spambots. You need JavaScript enabled to view it.
The obtained permits:
In 2019 we obtained the permit from the Ministry of Health [Single European Code for tissues and cells PL011231] to:
• collecting, processing and storing of subcutaneous adipose tissue,
• umbilical cord collecting, processing, storing and product authorisation
• collecting, processing, storing and product authorisation and distribution of mesenchymal cells isolated from adipose tissue,
• collecting, processing, storing and product authorisation and distribution of Wharton’s jelly-derived mesenchymal cells.
In 2021 we obtained Chief Pharmaceutical Inspector’s permit for the manufacture of Advanced Therapy Investigational Medicinal Product (ATIMP).
The Laboratory and equipment
The laboratory premises are under constant control in terms of environmental parameters, microbiological cleanliness and air particle counting. Each of the laboratory rooms, according to their classification of cleanliness, meets the requirements pursuant to the Regulation of the Minister of Health of 9 November 2015 on Good Manufacturing Practice and the Act of 6 September 2001 Pharmaceutical Law.
The permission to enter the controlled-condition laboratory areas is granted only to the authorised persons wearing special, laboratory coverall. The laboratory equipment, which is regularly tested and qualified, allows for the manufacture of medicinal products based on human stem cells.
Projects
In response to the challenges of regenerative medicine of the 21st century, it is vital to conduct clinical trials to verify the effectiveness and safety of new therapies so that the efforts to design them can prove productive.
Currently, as one of the partners of NeOStem consortium, we are engaged in a project cofounded by Medical Research Agency (Polish: Agencja Badań Medycznych). Our aim is to conduct non-commercial clinical trials to assess the effectiveness and safety of therapies combining regenerative stem cells together with biocompatible polyelectrolytes nanoparticles enhancing cells’ adjuvant effect through releasing neurotrophins (NTs) in neurodegenerative diseases: amyotrophic lateral sclerosis (ALS), retinal pigment degeneration (RP).
Cooperation
As a relatively young yet dynamically developing research team we are open to cooperation at new projects implementation. All the units are welcome to enter the collaboration: medical and pharmaceutical service providers, both public and non-public, hospitals, outpatient clinics, research institutes and universities.
