Cytori (CYTX) advances the cell therapy “ball” with effective topical administration in thermal burns

November 30, 2015 10:34am

This research, performed as part of development collaboration with BARDA, is planned for inclusion in an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury.

Pre-clinical data was published demonstrating that Cytori Cell Therapy can promote burn wound healing via topical spray delivery, achieving similar effects to local injection.

• The option for spray delivery expands the potential utility and offers greater ease of use for Cytori Cell Therapy in the burn setting.

The study was performed with support from the Biomedical Advanced Research and Development Authority (BARDA), and is described in a paper entitled “Adipose-Derived Regenerative Cell Therapy for Burn Wound Healing: A Comparison of Two Delivery Methods” (Foubert P. et al. DOI: 10.1089/wound.2015.0672 … http://online.liebertpub.com/doi/abs/10.1089/wound.2015.0672 .

The purpose of this study was to compare the effects of topical spray delivery and local injection of Cytori Cell Therapy in a porcine model of thermal burn.

• Importantly, the data demonstrated that administration by topical spray led to statistically significant improvement over control in epithelialization, blood vessel density, and inflammatory cell infiltration.

Results with topical spray were equivalent to those with local injection suggesting that delivery via a spraying mechanism is a viable and favorable alternative to other, more cumbersome delivery routes.

The Bottom Line: Results showed that delivery of Cytori Cell Therapy by topical spray or local injection of Cytori Cell Therapy increased wound epithelialization by about 21% over control at day 12 post-treatment (p<0.05). In addition, at day 7 post-treatment, digital analysis showed that micro-vessel density was significantly greater in wounds receiving either topical spray or local injection of Cytori Cell Therapy compared to control treatment (1.5-fold. p<0.05).

Finally, blinded histopathology and immunohistochemistry analyses showed that topical spray or local injections of Cytori Cell Therapy reduced neutrophil infiltration in burn wounds at day 7 post-treatment (p=0.05). The data are consistent with the cell therapy promoting angiogenesis, modulating inflammation and promoting wound repair.

CYTX closed at $0.37 and is UP +$0.02 or +5.13% to $0.39 ... the BARDA "ball" is being pushed forward; we need more.

The current standard of care of full-thickness burns requires early wound excision and application of autologous split-thickness skin grafts (STSG). For large injuries, STSG must be often widely meshed due to limited donor sites and are often associated with scarring and functional and cosmetic complications. Cytori Cell Therapy is potentially an attractive option to optimize skin graft healing and functional outcome. The results presented herein suggest that topical spray delivery or local injection of Cytori Cell Therapy may improve skin graft re-epithelialization and healing outcome and support the use of Cytori Cell Therapy as an adjunct therapy to skin grafting in severe burn patients.