Publisert 25.02.2015

Medibiome AB collaboration

Medibiome AB, Sweden and Regenics AS Oslo agrees collaboration on evaluation of Vernex™ in human skin explant model.

Medibiome AB, Sweden and Regenics AS Oslo has today agreed final protocoll (SPR105) for a collaboration for the first evaluation of Vernex™ in a human skin model. Medibiome AB has developed wound model on human explant skin (live skin removed from patients undegoing surgery). In collaboration with histologists/pathologist a tissue incubation model for such explants allowing secondary burn wounds or incisional wounds to be induced in the explant human tissue for subsequent blinded testing with optimal growth medium controls for effects on reepitelialization and safety.

Medibiome AB, CEO Kristina Blom explains: "Using live skin explants to evaluate wound healing processes in an ex vivo skin model allows comparison of both normal growth and re-epithelialization and healing under suboptimal or “hard to heal” conditions where exposure conditions for the skin explants can be varied (e.g. by suboptimization of growth factors). Both incisional and partial necrotic burn wounds will be studied in protocol SPR 105 with Regenics AS "

The human skin used in REGENICS’ sponsored study will be performed in a collaboration with Department of plastic Surgery, Sahlgrenska Hospital , Sweden. Skin tissue will be obtained after breast or abdominal reductions. It is regarded as “discarded tissue” and is anonymous to the sponsor. The study will not need Ethical Comitee clearance in Norway or Sweden nor Biobank approval as legislation in the Medical care Acts in Sweden is not applicable and ethical committee approval under the Swedish law of ethical review, 2003:460, § 4-3 and review by the local ethics committee is not required. The Personal Data Privacy Act is neither applicable since all materials are unknown to the sponsor and no activity to obtain any personal data is performed. Thus patient information and consent are not required by law but in force depending on the policy of the skin providing clinic. A purchase agreement with the Department of Plastic Surgery at Sahlgrenska hospital in Gothenburg, Sweden is beeing  set up by the outsourced partner (Medibiome AB). The Sahlgrenska clinic has chosen to inform the patients and to ask for their consents. Explants will be transported in physiologic saline to the laboratory of Medibiome AB (Gothenburg).

The ex vivo wound healing model of Medibiome is not validated. Medibiome customizes its method primarily based on the methods described by Kratz et al., Fredriksson et al., and Xu et al.



The project was supported by:


Regenics AS have developed clinical proof of efficacy and safety  in human 2 degree burn wounds for our products Collex® and Vernex®.

The procudts are beeing developed as class III devices. WoundClear® is developed as a BLA/EU CP biotech drug.