ImmuneSafe® is a cell product developed by Cell2B targeting acute steroid-refractory Graft-versus-Host Disease (GvHD), a major complication of bone marrow transplantation, with unmet clinical response. ImmuneSafe® ability to modulate the immune and inflammatory responses in our bodies is the basis for its potential use for the treatment of other immunological and inflammatory diseases, such as Inflammatory Bowel Disease (IBD), Acute Liver Failure, Rheumatoid Arthritis (RA) or the rejection of solid organ transplants. Upon stimulation by a pro-inflammatory microenvironment, ImmuneSafe acts through its primary mechanism of action that it is based on the production of a variety of soluble factors, which interact and modulate the responses of body’s immunological system and promote tissue regeneration.
In ImmuneSafe® manufacturing process, the cells are isolated from healthy bone marrow donors through a proprietary production system, expanded using a robust animal-origin free process and cryopreserved. When required by the physician the product is prepared and sent to the hospitals in a very short period of time.
The proprietary isolation and production process translate into the following ImmuneSafe features:
- Cell therapy platform: due to its wide range of mechanisms of action (immunomodulatory, anti-scarring, anti-apoptotic, mitotic and angiogenic), it can potentially be used for the treatment a variety of immunological and inflammatory diseases;
- Animal-origin free product: the manufacturing process uses only non-animal derived components (e.g. fetal bovine serum);
- Low level of expansion: low cell population doublings level (PDL), reducing the risk of genetic abnormalities and loss of therapeutic properties;
- No safety issues: no risk of contamination with pathogenic agents from the animal-derived components; it has a reliable safety profile, based on a extensive product characterization;
- Off-the-shelf product: no compatibility issues;
- Ease of use: it is administered via intravenous line.
The combination of these features gives ImmuneSafe unique advantages within cell therapy product class, as it will be the animal-free cell product first product under clinical evaluation for several indications, thus establishing a new standard in the Regenerative Medicine field.