Institute of Experimental Medicine AS CR, v. v. i. › Research › Research Centers

Innovation Biomedical Centre

Head: Petr Bažant, PhD, MBA

Phone: +420 296 443 350
E-mail: bazant@biomed.cas.cz

Innovative Biomedical Centre (IBC) aids the development and successful start-up of spinoff companies based on scientific outputs from the Institute of Experimental Medicine. IBC encourages cooperation between companies, research institutes and investors.

Since 2008, IBC IEM AS CR has been a member of the Science and Technology Parks CR (www.svtp.cz).

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Innovative Biomedical Centre (IBC) is situated in close proximity to the Institute in Prague 4-Krc, on the campus of the Academy of Sciences‘ biomedical institutes. Its construction, which took place in 2007–2008, was financed in part by EU funds.	The Science and Technology Parks Association of the CR awarded the Innovation Biomedicine Center accreditation in October 2008.

IBC services for innovative start-ups are oriented in three, closely cooperating directions:

Promoting competitiveness in biomedicine – training in the fields of marketing, intellectual property protection, sales organization, management, financial management, project preparation, grant applications legal acts related to the establishment of companies, public procurement, and assistance in the implementation of good manufacturing practice. Training and coaching are arranged so that startups overcome the most common pitfalls: poorly assembled business plans and financing models, maladjusted relationships and contracts with investors, bad management firms, corporate compliance obligations under the Act, and inadequate protection of intellectual property.

Support for applied research in biomedicine – certified services under Good Manufacturing Practice: sterility tests, sampling sets production, separation and cultivation of stem cells, etc.

Business incubator for spin-off companies – services provided to othercompanies: office and laboratory rental, computer network management, purchasing management, patent and tax services, inventory management, reception, post office, administration and maintenance of real estate, business presentations, finding investors, and assistance in closing contracts. Currently, the business incubator is fully occupied.

Bioinova, Ltd.

Michael Syka, MD
Manager of clinical projects
E-mail: michael.syka@biomed.cas.cz
Tel.: +420 241 063 350
www.bioinova.cz

Bioinova was founded in 2008 as a spin-off company of IEM AS CR. The company focuses on the development and production of advancedtherapy medicinal products (ATMP) containing stem cells. In 2010 Bioinova obtained its Good Manufacturing Practise (AMP) lisence for the production of ATMP containing stem cells, it has also successfully passed several periodical audits of the State Institute for Drug Control (SIDC). In 2014, Bioinova was approved as the tissue establishment facility by SIDC.

Currently, Bioinova sponsors three clinical trials: AMSC-ALS-001, AMSCRC-001, AMSC-DSD-001 and manufactures the ATMP product for another clinical trial: AMSC-BDT-001.

In 2014, Michael Syka, MD, was appointed as the Manager of clinical projects for Bioinova. The CEO of the company remains Petr Bažant, MSc, PhD, MBA and Kateřina Růžičková, PhD remains the head of the quality control department. Šimona Konrádová, PhD leads the manufacture department and Petra Marková, PhD is responsible for the monitoring of clinical trials. The qualifi ed person and chief of the quality assurance department is Ivana Drahorádová, MSc. The team is supported by Zuzana Kočí, MSc who manages applied research and preclinical studies. Cleanroom laboratory work is conducted by an experienced team of technicians: Jana Tenkrátová, Jana Káclová and Nicole Matějíčková, BS.

Clinical projects:

Since its foundation, Bioinova works in tight cooperation with leading clinical centres in the Czech Republic.

In cooperation with University Hospital Motol, Bioinova conducts the clinical trial AMSC-ALS-001 (ongoing since 2012) that aims to verify the safety and effi cacy of the intrathecal administration of autologous multipotent mesenchymal stem cells in patients diagnosed with amyotrophic lateral sclerosis. In addition to 20 patients, another 6 were treated in 2014; in the fi rst half of year 2015 three more subjects are expected to be enrolled.

Another clinical trial AMSC-RC-001 (ongoing since 2013) focuses on using autologous multipotent mesenchymal stem cells in orthopedics to accelerate healing after rotator cuff surgery. This trial is also conducted by Bioinova in cooperation with University Hospital Motol. In addition to 3 patients, another 6 were treated in 2014; 11 more patients are planned to be enrolled in the following year.

Clinical trial AMSC-DSD-001 (ongoing since 2013) focuses on using autologous multipotent mesenchymal stem cells in spondylosurgery to accelerate vertebral fusion in degenerative spine disease. This trial is also sponsored by Bioinova and conducted in cooperation with University Hospital Motol. In addition to 4 patients, another 5 were treated in 2014; 11 more patients are planned to be enrolled in the following year.

In the clinical trial AMSC-BDT-001 (ongoing since 2013), Bioinova manufactures its investigational medicinal product for another sponsor – University Hospital Hradec Králové. This trial investigates the effect of the administration of autologous multipotent mesenchymal stem cells during reimplanation of hip arthroplasty. In addition to 7 subjects, another 7 were treated in 2014; 5 more patients are planned to be enrolled in the following year.

For the year 2015, Bioinova is preparing a new clinical trial to evaluate the safety and efficacy of the intrathecal administration of autologous multipotent mesenchymal stem cells in the treatment of severe spinal cord injury (grade A, B or C, according to ASIA classification). Safety and efficacy of repeated intrathecal administration of autologous multipotent mesenchymal stem cells in patients with amyotrophic lateral sclerosis will be assessed in another clinical trial.

Also, Bioinova is designing a multi-center clinical trial which will be carried out in University Hostpital Motol, University Hospital Plzeň and Masaryk Hospital Ústí nad Labem to evaluate the safety and efficacy of the administration of autologous multipotent mesenchymal stem cells for the treatment of osteochondral lesions.

Regenerative medicine and tissue engineering:

Stem cell research and tissue repair provides great hope for the treatment of patients following brain and spinal cord injury, Alzheimer‘s disease, Parkinson‘s disease, diabetes, skin burns, damaged joints and arthritis, bone repair, loss of vision and hearing, as well as other incurable diseases.

The use of stem cells together with tissue engineering has brought about revolutionary possibilities for finding cures to such conditions. Studies of animal models and initial clinical studies using stem cells have demonstrated their huge potential in medicine, bringing hope to an aging population and countless patients suffering from a wide range of devastating diseases.

The core research carried out at the institute is directed towards the study of all the currently known types of multipotent cells. We now know that both autologous and allogeneic mesenchymal cells as well as embryonic, fetal, and induced pluripotent cells all have promising therapeutic effects.

Very often cell therapies need to be combined with either a natural or synthetic carrier. With this in mind fundamental multidisciplinary research in this area is necessary for the progression of future treatment.

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Bioinova employs a team of qualified professionals who specialize in preparing manufacturing processes, clinical trials and registration procedures for somatic cell therapy products and provide GMP services in the field of regenerative medicine and tissue engineering for the needs of clinical trials, the registration of medical devices and medical practice.