Technology

Rigenerand owns proprietary technology that allows more efficient ex-vivo stem cell cultures for safer cellular therapies.Rigenerand develops & produces biomedical tools to empower the ex-vivo phase of stem cells expansion combining the need of high cell yield with innovative biocompatible materials.By novel solutions, Rigenerand aims to miniaturize biomedical devices for stem cell amplification, increasing expansion safety and contemporaneusly reducing production costs for large scale pre-clinical uses and for a broad spectrum of clinical indications.

Know-how

Rigenerand industrial partner, Rand, has matured a considerable experience in development and production of several Bio-Artificial (BAL) systems for temporary liver support based on 3D synthetic matrix already used in phase I clinical trials. Rand co-operates worldwide with major research groups in the BAL field: MAYO Clinic (Rochester), HEPALIFE (Boston), VITAL THERAPIES (San Diego), AMC (Amsterdam). This know-how represents the core technology for Rigenerand products development.

Rand is a certified company according to: 21 CFR 820 QSR for Medical devices (FDA) for CPB equipment; EC Certificate MDD Annex II.3, ISO 13485 for Extracorporeal Circulation Equipment and related disposable device and for disposable devices for cell separation, culture and preservation of animal and human cell in bio-artificial systems; CMDCAS Canadian Regulations; ᶲC3 2011/09371 Russia for Performer HT equipment and disposable.

Rigenerand academic partner, University of Modena and Reggio Emilia and his researchers, has matured an internationally recognized experience in stem cell biology and his application in regenerative medicine and oncology. In vitro and in vivo technological platforms for stem cells engineering have also been implemented.
With this know-how, Rigenerand wants to propose innovative products facing current limits of stem cells ex-vivo amplification and coupling advanced biomedical production with concrete laboratory needs to produce advanced solutions for stem cells manipulation.

State of the art

Cell therapies and tissue engineering are promising fields in biotechnology to regenerate damaged tissues due to congenital or acquired diseases. Tissue regeneration is based on an apparently simple concept: exchange pathological and / or missing cells with novel cell populations capable of regenerating the damaged tissue. Between many cell types present into living beings, cells defined as “adult stem cells” represent, at the moment, promising players for regenerative medicine.

Adult stem cells are isolated from several origins such as bone marrow, adipose tissue, cord blood and others; being rare elements, they require ex-vivo isolation and/or expansion in significant quantities. This expansion phase allows precise biological characterizations of transplantable cells, obtaining at the same time the desired therapeutic doses. Commonly, stem cell ex-vivo expansion is still made by means of a plastic bi-dimensional support, historically defined as tissue culture “flask”, a plastic container with screw cap and filter capable of hosting living cells in association with culture medium for their expansion.

While this technique is suitable for limited cell number and culture media volumes commonly utilized, in non-classified “standard” research laboratories, in case of “clinical grade expansion”, where hundred millions of cells are required, the expansion phase in flasks may be extremely problematic. Within these contexts, the limits of standard tissue cultures emerge. In particular, the large size and therefore the handling substantially limit their use. In addition, in tissue culture flasks, culture media and cells occupy less than one tenth of the overall volume, making these tools poorly efficient.

Tissue culture flasks are also open systems designed to host cells and media loaded via neck with a screw cap: In case of large tissue culture this design could expose cells to contamination risks. Finally, tissue culture flasks must be allocated into CO2 incubators having a controlled atmosphere but a fairly limited space.
When a significant quantity of stem cells is required, as for clinical needs, the high number of necessary flasks (and relevant incubators) determine a great volumetric impact with consequent higher contamination risks during the process, affecting at the same time (a) laboratory spaces, (b) culture media needs and (c) working time/production costs.