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In vitro method for predicting the biocompatibility of medical implants

Country of Origin: Spain
Reference Number: TOES20170214001
Publication Date: 14 February 2017

Summary

Spanish universities have developed a method for predicting the biocompatibility of materials used in medical implants, such as dental prostheses, valves and stents. The invention consists in an accelerated test of the biocompatibility of materials that makes it possible to rule out those with poorer prospects of success during the in vitro phase. The costly investments required to perform unnecessary in vivo trials are avoided. Researchers are seeking license or technical cooperation agreements

Description

The success of an implant depends on its biological integration within the organism. The aim is to achieve this integration in the shortest possible time, which means preventing the immune reaction from getting out of control in terms of both intensity and time (chronicity) and, ultimately, that no foreign body reaction and implant rejection take place. Hence, the implants must be manufactured with materials that showed compatibility with living tissues, that is to say, with proven biocompatibility. The candidate materials have to undergo complicated tests before they can be approved for use as medical implants. Such testing ranges from in vitro assays to determine their cytotoxicity to in vivo trials with the prototypes that have displayed good properties in the in vitro assays. They also have to be submitted to preclinical studies as well as clinical trials in humans. This is a very long and costly process.

Spanish researchers from universities and research centres have developed a new in vitro method for predicting the biocompatibility of materials to be used in the manufacture of medical implants, such as joint and dental prostheses, valves and stents, among others. The invention consists in an accelerated test of the biocompatibility of materials that makes it possible to rule out those with poorer prospects of success during the in vitro phase. As a result, the costly investments required to perform unnecessary in vivo trials are avoided and the new materials can be tested in the clinical phase sooner. It is based on the detection of a group of proteins linked to the inflammatory reaction. The novelty lies in the fact that a robust correlation has been established between the protein profile obtained by in vitro tests and that one acquired by means of in vivo trials, which are, by definition, more reliable.

Although the in vitro cytotoxicity and cell proliferation trials yield good results, what eventually happens is that the material being tested fails to display a good level of biocompatibility in the in vivo tests. In such cases, the in vivo assays are a complete waste of time and resources, and they also involve the death of a significant number of animals.

What if it would be possible to predict or forecast the biocompatibility of the new materials in the in vitro phase, so as to be able to rule out the less promising candidates and save on costs? This is what is proposed with this technology. Researchers have identified a profile of protein markers, related with the immune response, which can be analysed in an isolated in vitro biological sample. The presence of this protein above a certain reference level indicates a lack of in vivo biocompatibility. Thanks to this in vitro / in vivo correlation, the new method uses the determination and quantification of those markers in in vitro samples to predict or forecast the biocompatibility of biomaterials/implants.

The technology is useful for:
• Manufacturers of medical prostheses: dental implants, hip and knee replacement prostheses, etc. Any company that makes materials designed to be in contact with bone.
• Manufacturers of biomaterials
• Manufacturers of kits for determination of biocompatibility.
• R&D centres. Groups that perform in vitro and in vivo trials applied to the development of new biomaterials in order to determine their biocompatibility.
• Dental clinics, hospitals and other players involved in the placement of prostheses. Application in this sector would be at patient level. Based on the results of a simple blood test, the patient would be given detailed information about whether it is likely to suffer complications in joint replacement surgery.

Researchers are looking for companies, research centres or hospitals interested in licensing the technology for its application to the development of new materials for medical implants. Technical cooperation agreements for further development of the technology will be welcome too.

Advantages and Innovations

The main advantages offered by this technology are:

• It is a fast reliable in vitro method that compares well with the results obtained at the in vivo level.
• It speeds up and reduces the costs of the development of materials for the manufacture of medical implants to a notable extent, since it makes it possible to rule out the materials that showed a lower degree of in vitro biocompatibility, and consequently avoids the need to go for costly in vivo trials. New materials will be developed for prostheses or regenerative medicine at a lower cost and in less time
• It also allows personalised pre-implantation diagnoses to be reached for individual patients in order to determine the likelihood of an implant being rejected by the body and, accordingly, prescribe the type of prosthesis with the greatest prospects of success.
• It also allows to reduce the number of animals used in experimentation.

The main innovative aspect of this method is that it is based on an analysis of the peptide profile which has been proved to have a robust correlation between the in vitro results and the biocompatibility exhibited by the material under in vivo conditions. None of the accelerated tests based on protein developed to date have shown evidence of such a correlation, without which it is not possible to match the results obtained in vitro with what will later happen with the material implanted inside the body.

It would enable firms and research centres to increase their productivity related to the search for new biocompatible materials. By offering an indication of the biocompatibility of the materials being developed, it becomes possible to rule out those with few chances of success at an early stage, thereby saving the costs of conducting in vivo trials.

Stage Of Development

Prototype available for demonstration

Stage Of Development Comment

The method has been validated and a prototype kit is available.

Requested partner

- Type of partner sought: Medical implants manufacturers / Biomaterials developers / Biotechnology companies / Hospitals and healthcare sector

- Specific area of activity of the partner: Manufacturing and commercialization of medical implants / Development of biomaterials / Development of kits to biocompatibility determination / Implant of internal prosthesis

- Task to be performed: license the technology for its use or technical cooperation for adaptation of the technology

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