Preclinical Trials

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Preclinical Trials

Due to cutting-edge equipment as well as highly qualified staff we provide you the opportunity to conduct clinical trials in accordance with the European Union
and the United States standards

Location of the Preclinical Research Laboratory at the Institute of Animal Production in Kostkowice ensures the availability of a number of animal models and professional care of animals. The Laboratory is adapted to perform surgical procedures requiring general anaesthesia.

In 2014 in the Preclinical Research Laboratory was carried on work on intravascular stents (coronary stents, carotid stents, renal stents, peripheral stents, etc.) and intravascular administration of stem cells. There were also conducted tests on angioplasty balloons coated with antiproliferative drugs, angioplasty balloons with local administration of drugs and self-expanding stents. Moreover, we conducted trainings for physicians in the field of thrombectomy and implantation of self-expanding stents.

List of exemplary preclinical trials conducted in the Preclinical Research Laboratory:

Wide range of services

  • Evaluation of feasibility and safety of mechanical thrombectomy on animal model of ischemic stroke in a domestic swine
  • Controlled reperfusion performed with a therapy that consists of hypothermia and hardening after ischemic stroke in the domestic swine
  • Evaluation of feasibility and safety of self-expanding coronary stents implantation
  • The use of stromal-vascular cell fraction in proliferation of liver parenchyma
  • Evaluation of pharmacokinetics, safety and efficacy of microspheres releasing locally anti-cancer drugs, applied in embolization of arteries that supply a tumour and in reduction of the tumour mass
  • Preclinical evaluation of the possibility of implantation and safety of the first Polish transcatheter low-profile aortic valve
  • Evaluation of biological response of coronary stents coated with a biodegradable polymer eluting sirolimus with a design optimized for implantation in coronary artery branches in a domestic swine model of coronary artery restenosis
  • Evaluation of safety and efficacy of percutaneous closure of atrial septal defect with an occluder in the PFO treatment, made of a nitinol wire mesh
  • Evaluation of safety and efficacy of intravenous administration of mesenchymal stem cells on the model of an acute limb ischemia under controlled hyperglycaemia in a rabbit
  • Preclinical evaluation of safety and technical feasibility of renal arteries denervation using chemical neurolysis on the model of the domestic swine.
  • Effect of cyclosporine A and hardening with reperfusion on damage of the coronary microcirculation in the experimental model of myocardial infraction in the domestic swine.
  • Experimental model of atherogenesis in the domestic swine coronary artery
  • Evaluation of safety and feasibility of vascular filters implantation in the domestic swine model.

Technical background

The Centre for Cardiovascular Research and Development American Heart of Poland in Kostkowice comprises the following facilities/equipment:

  • a fully equipped hemodynamics room based on Siemens angiography
  • an operating room
  • magnetic resonance imaging (MRI) – MRI Signa EXCITE 1.5T
  • ultrasound VIVID 6
  • intravascular ultrasound (IVUS)
  • intravascular optical coherent tomography (OCT)
  • systems for vital signs monitoring
  • devices to enable the preparation of samples for histopathological analysis
  • tissue and cell culture laboratory
  • cell separator
  • image analysis software angiography (GE OEC 9800) and statistical tools
  • Broadband Internet connection to enable live broadcasts
  • conference room

Cykl innowacji

  1. 1

    Innovation, translational research

  2. 2

    Formal aspects

  3. 3

    Pre-clinical trials

  4. 4

    Clinical trials

  5. 5

    Implementation and dissemination of results

1. Innovation, translational research

Medicine is an extremely dynamic economic and social area of the modern world. Medical innovations emerge every day in different parts of the world. In the R&D Centre we cooperate with entities that are determined to launch innovative solutions, especially in the area of cardiology, cardiac surgery, vascular surgery, rehabilitation and telemedicine. We have competence, knowledge and capabilities to support the process of innovation at every stage, from ideas, through pre-clinical and clinical trials, to presentations at international conferences and congresses. We consult the assumptions of each project, we advise and optimize the planned course of study, with a view to introducing a solution to clinical practice.

2. Formal aspects

We support obtaining research authorizations from relevant institutions (Ethical Committee for Experiments on Animals, Bioethics Committee, Office for Registration of Medicinal Products). The research projects are carried out in accordance with the standards of the Good Laboratory Practice and the Good Clinical Practice, ensuring data reliability through high quality and repeatability of the obtained results.

3. Pre-clinical trials

Much of the medical innovations require detailed pre-clinical trials, from biocompatibility testing to implantation of prototype medical devices and verification of the safety and feasibility of procedures. At the Experimental Laboratory of the R&D Centre we provide opportunity to conduct research in accordance with all requirements and standards applicable in Poland, the European Union and the USA.

4. Clinical trials

After the completion of pre-clinical phase, we provide a unique opportunity to continue the study in the experienced clinical centers of American Heart of Poland and collaborating centers. First-in-Man studies are the first step in obtaining a CE Mark and then introducing a product into the market, followed by a full, multi-center clinical trial. Before the start of the clinical trial, a test protocol is prepared and training is provided to the research team. The following persons are involved in implementation of a study: lead investigator, investigator, clinical trial coordinator, department head, nurse staff, technical staff. The course of the study is monitored by an independent entity and verified for adverse events. At the end of the study, a final report summarizing the course and the results of the study is created.

5. Implementation and dissemination of results

Innovations undergoing the full cycle from concept to clinical application require further steps to be successful in the market. R&D Centre staff conducts training of physicians concerning the use of new medical devices and the implementation of new surgical techniques. It is worth pointing out that the results of research conducted in the R&D Centre are widely published in prestigious international journals and presented during conferences and congresses.

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