Cell and Tissue Engineering

doc. RNDr. Irena Koutná, Ph.D.

E-mail: irena.koutna@fnusa.cz
Phone: +420 54 318 5571

Irena Koutná’s main field of expertise is cell therapy and regenerative medicine. In addition to leading her own research group at the International Clinical Research Center (ICRC), a joint workplace of St. Anne’s University Hospital in Brno and the Faculty of Medicine of Masaryk University, she also lectures at the Department of Histology and Embryology at the Faculty of Medicine, Masaryk University. In the spring of 2020, together with her team, she introduced a methodology for testing memory immunity after COVID-19, tracking how the memory response evolved and declined over the long term following the illness. They also studied the development of memory immunity.

When cells heal

The CTEF department consists of two teams:

The Center for Cell and Tissue Engineering, St. Anne’s University Hospital in Brno (CTEF-FNUSA) – production in SVP/GMP quality.
The Center for Cell and Tissue Engineering, Masaryk University (CTE-MUNI) – research division.

The Cell and Tissue Engineering Center of St. Anne’s University Hospital Brno (CTEF-FNUSA) is a specialized team of experts focused on the manufacturing and quality control of medicinal products for advanced therapies, including cell and gene therapy.

CTEF is certified for Good Manufacturing Practice (GMP), allowing the production of medicinal products as well as advanced therapy medicinal products (ATMPs), and also complies with ISO 9001 standards.

Team members:

Doc. RNDr. Irena Koutná, Ph.D. (Head of CTEF)
RNDr. Daniela Hulínová (Production Manager)
Mgr. Tereza Souralová (Implementation Science Manager)
Mgr. Ivana Ťapuchová (Quality Control Manager)
Ing. Petra Česnek, Ph.D. (Lab Manager)
Ing. Marie Vávrová (Qualified Person)
Mgr. Jindřich Beránek (Laboratory Technician Specialist)
Mgr. Eliška Buštíková (Laboratory Technician Specialist)
Mgr. Barbora Frimlová (Laboratory Technician Specialist)
Ing. Lucie Müllerová, Ph.D. (Laboratory Technician Specialist)
Mgr. Katarina Streďanská (Laboratory Technician Specialist)
Mgr. Milan Hluchý, Ph.D. (Laboratory Technician Specialist)

Lab Manager:

Ing. Petra Česnek, Ph.D.
543 185 581
petra.cesnek@fnusa.cz

email for orders: objednavky-ctef@fnusa.cz

Our Goals

Collaborating with doctors to advance modern medicine and thus help patients
Developing procedures for the production of cell and tissue preparations for preclinical and clinical applications
Establishing procedures for thorough characterization and product release using analytical methods
Manufacturing and quality control of products in accordance with GMP (Good Manufacturing Practice) and their release
Pushing the boundaries of personalized medicine in the Czech Republic
Keeping pace with global trends in cell and gene therapies
Ensuring the competitiveness of the Czech Republic in the global production of cellular products

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Our Products

The manufacturing of products at our clinic is carried out in accordance with Good Manufacturing Practice (GMP) standards and is approved according to the requirements of the State Institute for Drug Control (SÚKL) or the European Medicines Agency (EMA).

VSL = virus-specific lymphocytes
Virus-specific T cells (VSTs) are a special type of immune cells that are trained to recognize and fight viruses. These cells can be collected from a donor, isolated, and administered to a patient whose immune system is too weak to fight off viral infections – for example, after a transplant.

This approach is especially promising for patients facing viral infections such as CMV (Cytomegalovirus), EBV (Epstein-Barr virus), AdV (Adenovirus), or SARS-CoV-2 after transplantation.
This treatment is covered by public health insurance.
CAR T lymphocytes = T lymphocytes with a chimeric antigen receptor

CAR-T lymphocytes are modified immune cells that are “programmed” to find and destroy cancer cells. In the laboratory, T lymphocytes collected from the patient are genetically engineered to express a receptor (called a CAR – chimeric antigen receptor) that can recognize a specific target on the surface of the tumor.

The production of GD2 CAR-T cells is currently being optimized for clinical evaluation.
The production of CD19 CAR-T cells is in the optimization phase in collaboration with the Institute of Hematology and Blood Transfusion (UHKT).

PBMC = Peripheral blood mononuclear cells
Mononuclear cells of peripheral blood include lymphocytes (T lymphocytes, B lymphocytes, NK cells) and monocytes. PBMCs are isolated using a density gradient from the full, non-coagulated blood of the donor.

Selected PBMCs with precisely determined representations of individual populations are stored in liquid nitrogen and prepared for research use or serve as input biological material for further productions in GMP quality.
Mesenchymal stromal cells for the treatment of GVHD

Mesenchymal stromal cells are obtained from umbilical cord tissue. MSCs from this source exhibit a significantly greater natural ability to modulate immune responses and inflammation compared to cells derived from other tissues, such as bone marrow.

These properties make them an ideal candidate for the treatment of graft-versus-host disease (GVHD), a serious complication after transplantation. Thanks to this, they bring new hope to patients who do not respond to standard therapies.

EVs = Extracellular Vesicles for the Treatment of Neurodegenerative Diseases
Extracellular vesicles are small particles released by cells (e.g., from MSCs) that naturally carry therapeutic molecules and signals capable of reducing inflammation and promoting the regeneration of damaged nerve cells. Thanks to these unique properties and their ability to cross the blood-brain barrier, they are highly promising for the treatment of neurodegenerative diseases.

This innovative therapeutic approach offers new hope for patients suffering from Alzheimer’s or Parkinson’s disease, for whom current treatment options remain insufficient.

The therapy is currently in the stage of preparation and optimization.

Our Services

If you are interested in any of the services listed above, please contact us at the email address objednavky-ctef@fnusa.cz or using the contact form below.

(Currently, our laboratory meets the requirements of GMP (Good Manufacturing Practice) for modern therapies and ISO 9001.)

Determination of cellular immunity (CMV, EBV, JCV, BKV, AdV, SARS-CoV-2)
Cytokine determination using the ELISA method
Evaluation of T-cell proliferation suppression or activation using CFSE stainig
Quantification of gene copy number by digital PCR
Determination of cell populations using flow cytometry
Cytotoxicity determination using MTT on cell lines

If you are interested in any of the services listed above, please contact us. (Currently, our laboratory meets the requirements of GMP (Good Manufacturing Practice) for modern therapies and ISO 9001.)

Certifikat_ISO_2024
Certifikát SVP_VSL,PBMC,CAR-T_14.7.2023
Certifikát SVP_MSC_11.12.2024

To learn more, write to us!
objednavky-ctef@fnusa.cz

How to get to us?

Collaboration

Selected publications

ŤAPUCHOVÁ, Ivana, Robert PYTLIK, Pavel ŠIMARA, Lenka TESAŘOVÁ a Irena KOUTNÁ. Cytomegalovirus and other herpesviruses after hematopoietic cell and solid organ transplantation: From antiviral drugs to virus-specific T cells. Transplant Immunology. Amsterdam: Elsevier B.V., 2022, roč. 71, April, s. 1-13. ISSN 0966-3274. doi:10.1016/j.trim.2022.101539.

SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL a Irena KOUTNÁ. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval. In Stem Cell Production. Singapore: Springer, Singapore, 2022. s. 185-203, 18 s. ISBN 978-981-16-7588-1. doi:10.1007/978-981-16-7589-8_8

LUKJANOV, Viktor, Irena KOUTNÁ a Pavel ŠIMARA. CAR T-Cell Production Using Nonviral Approaches. Journal of Immunology Research. London: Hindawi, 2021, roč. 2021, Mar 27, s. 1-9. ISSN 2314-8861. doi:10.1155/2021/6644685.

ŘEHÁKOVÁ, Daniela, Tereza SOURALOVÁ a Irena KOUTNÁ. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. International Journal of Molecular Sciences. Basel: MDPI, 2020, roč. 21, č. 7, s. 1-14. ISSN 1422-0067. doi:10.3390/ijms21072435.

FARKAS S, SIMARA P, REHAKOVA D, VEVERKOVA L, KOUTNA I. Endothelial Progenitor Cells Produced From Human Pluripotent Stem Cells by a Synergistic Combination of Cytokines, Small Compounds, and Serum-Free Medium. Front Cell Dev Biol. 2020 May

TESAROVA L, JARESOVA K, SIMARA P, KOUTNA I. Umbilical Cord-Derived Mesenchymal Stem Cells Are Able to Use bFGF Treatment and Represent a Superb Tool for Immunosuppressive Clinical Applications. Int J Mol Sci. 2020 Jul 28;21(15):5366

REHAKOVA D, SOURALOVA T, KOUTNA I. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. Int J Mol Sci. 2020 Mar 31;21(7):243

TESAROVA, L., SIMARA, P., STEJSKAL, S., KOUTNA, I.The Aberrant DNA Methylation Profile of Human Induced Pluripotent Stem Cells Is Connected to the Reprogramming Process and Is Normalized During In Vitro Culture.PLoS One. 2016, 11(6), e0157974.

STEJSKAL, S., STEPKA, K., TESAROVA, L., STEJSKAL, K., MATEJKOVA, M., SIMARA, P., ZDRAHAL, Z., KOUTNA, I. Cell cycle-dependent changes in H3K56ac in human cells. Cell Cycle. 2015, 14(24), 3851-63.

TESAROVA, L., STEJSKAL, S., KOUTNA, I.Driven hematopoietic differentiation of embryonic stem cells: epigenetic perspectives. CurrentPharmaceutical Design. 2014, 20(11), 1674-86.