VeritaCell – a novel method for human skin regeneration

Scope of the project In order for VeritaCell to perform first-in-man clinical trials and be ‘ready-to-go’ for market entry, it urgently needs to overcome two barriers: a) to optimise one critical component of its kit, and b) to finalise its regulatory clinical pathway for approval by regulatory authorities. The project will allow VeritaCell to complete these two final steps and guarantee market entry by 2025. Specific aims – and challenges to address 1. Laboratory (cell culture) work The VeritaCell kit can isolate (within ~30-minutes) the patient’s own healthy skin cells from one part of their body and create a ‘liquid skin’ sample for immediate application to the part of the body where the wound is located. The method uses an enzyme (trypsin) that separates (disaggregates) skin cells; yet, it requires the use of a product that is GMP-compliant (i.e., the enzyme can be used clinically). VeritaCell have identified a well-established supplier (Merck) whose product is an enzyme that is GMP-compliant and there is an agreement-in-principle for its use in the VeritaCell kit. However, it is essential that the enzyme (CellPrime®) is tested in the laboratory to confirm its ability to perform optimally in the VeritaCell method. The laboratory work at the UoH will utilise the extensive cell biology expertise of the applicant (who is one of the two biologists on the Paxman Research Project) in skin models, and he will supervise an existing PDRA who has all the laboratory skills required for isolation and culture of human skin cells. The work will involve the optimisation (i.e., defining the precise concentration of the CellPrime enzyme and duration of treatment) required for the effective isolation of cells (keratinocytes, fibroblasts & melanocytes) using the VeritaCell method. CellPrime will be compared with the existing enzyme (TrypLE, from ThermoFisher). 2. Mapping route to market and finalising the regulatory pathway for the technology Initial contacts between VeritaCell and regulatory bodies (MHRA and EMA) indicated that the VeritaCell kit could be regarded as a medical device, as it facilitates the creation of a solution (cell suspension) which is applied to the patient’s wound. However, as the product applies cells and utilises an enzyme (trypsin), this has raised the probability that the product may need to be considered as an Advanced Therapy Medicinal Product (ATMP). It is, therefore, essential that VeritaCell engages with a regulatory pathway consultant with the required expertise to clarify these issues to and finalise the regulatory pathway that must be followed both for European and US-based regulatory authorities. Project ‘fit’ to UoH strategy and benefits VeritaCell is a start-up created at the UoH and fits with its overall strategy to engage with commercial partners and exploit ‘knowledge transfer’ opportunities to accelerate technologies that can impact on human health. The long-term benefits of the project will not only be financial (in the form of royalties via the IP transfer agreement), but also academic benefits, in the form of peer-reviewed cell biology and clinical study publications, and an impact case study for the next REF round.