The research is conducted by the researchers from the Faculty of Biology and Environmental Protection of the University of Lodz, University of Wrocław, Cracow University of Technology, and the Łukasiewicz Research Network.
The project objective is to develop new polymer-ceramic composite biomaterials that would be used in regenerative medicine of bone tissue.
Bioactive composites are implants that will replace natural bone tissue, and most importantly speed up its healing process and ensure the correct bone reconstruction without the risk of inflammation. The substances included in the implant have already been tested and we are convinced of their effectiveness.
– explains Dr Karolina Rudnicka from the Department of Immunology and Infection Biology at the Faculty of Biology and Environmental Protection, University of Lodz.
These substances may be anti-inflammatory, antimicrobial or pro-regenerative which will help the implant to cooperate with human body more effectively.
Superpowers
The developed implant contains composites that have already been tested and deemed the most beneficial for the regeneration process of the damaged bone tissue.
– explains Dr Rudnicka.
Similar solutions are already being implemented around the world but they do not involve the substances that Polish researchers have been working on. Among the substances, one may find innovative polymer-ceramic base covered with growth factors that support blood supply in the VEGFA (Vascular Endothelial Growth Factor A) implant and demonstrating anti-inflammatory factors TGF-beta (transforming growth factor beta).
Their function may be compared to a message that is sent by the immune cells to inform other cells of what should be produced in a human body. We can use these messages by preparing an answer. We inform the cells that we do not want any inflammation within the body and get their reaction. The same answer might have been received in the physiological process but it would take much longer.
– says Dr Rudnicka.
Multifunctionality
The composites have many functions. The first one is the stimulation of bone cells to ensure the proliferating and production of bone tissue (osteoinductive properties). The second one is a pro-regenerative activity which supports cell regeneration. The third involves preventing the inflammatory reaction that would not be beneficial to the healing process.
One of the problems with TGF-beta is that it is very expensive. However, we have found a solution, we are able to force the bacteria to produce this factor. A gene, carrying information for TGF-beta production, is put in the bacteria that forces them to produce the necessary factor. Then, we clean the factors and verify their structure and activity, which allows us to obtain the factor that is cheaper than the commercial product.
– says Dr Rudnicka.
Another important function of the implant is its biocompatibility. The implant cannot be toxic, cause any allergies or irritate the cells.
We are testing this using cell models as well as in vivo which ensures that the implants will not only be active, but also safe.
– assures Dr Rudnicka.
Revolution at the same time
Total project budget is PLN 12mln, including 4.5mln for creating the team and biological research conducted by the scientists of the University of Lodz. Last year the researches manged to obtain another million for expanding the research on pyomelanin in the process of bone formation from the Foundation of Polish Science.
The idea appeared during the course of research. There is a disease (alkaptonuria) that involves accumulating melanin in the bone tissue, which causes its ossification. That is why, we have decided to use this compound to stimulate ossification, not in the joints, but in the bones where it is the most needed. Another step was finding a way to get the melanin, and in this case bacteria (Pseudomonas aeruginosa) proved to be helpful again.
– says Dr Rudnicka.
After placing it on a microbiological basis, the microbe is producing the microbial melanin, which in chemical terms is identical to the one that is accumulated in the joints of the patients with alkaptonuria. Due to the fact that there is a possibility of producing large quantities of bacteria, it is also possible to obtain large quantities of melanin.
Of course the process is not easy because the substance must be isolated, characterised and cleaned, yet thanks to our research it is already known that pyomelanin is safe for human tissue and has strong osteoinductive properties.
– she adds.
Research findings
So far, the project has been conducted for 2 years. The researches already know which substances, in which concentration and form, may support bone regenerative processes. But that is not all.
We can also extract them, and that is why in the future we will be able to add these factors to, for example, hydrogel dressings to improve the healing process.
– says Dr Rudnicka.
However, the main objective of the project is to create an implant for people with bone damage that would significantly reduce their time of hospitalisation and rehabilitation.
Commercialisation
The Scientific Research Committee is negotiating with companies that produce implants in order for the product to appear on the market.
We are also consulting surgeons and transplant surgeons. We talk about their expectations, try to determine whether it is possible to use our implants, and establish how fast should the implant metabolise within the body. Our final plan is to sell the licence to a company that will put our product on the market.
– says Dr Rudnicka.
One of the results of the project is the development of research workshop and researchers conducting OsteoRegNET project. The project allowed us to create a 9-person team, which received Rector’s Award for high activity in obtaining resources for research last year. We have published ten studies and we are co-authors of four applications to provide a letter patent for the solutions developed in the project. We are planning to share our research methodology on cytology, and regenerative, antimicrobial and ossification potential with other researchers by offering specialist training at the University of Lodz. The project will last until 2023. We are also planning to organise specialist courses on evaluating the safety and effectiveness of biomaterials for biomedical purposes.
– she adds.
The training starts this autumn.
The project Multifunctional Bioactive Composites for Regenerative Medicine of Bone Tissue (POIR.04.04.00-00-16D7/18) is implemented within the framework of TEAM – NET Programme of the Foundation of Polish Science funded by the EU from the European Regional Development Fund (ERDF).
Source: Faculty of Biology and Environmental Protection, University of Lodz