InGeneron has announced the publication of results from an investigator initiated case series in chronic leg wounds in the Journal of the European Academy of Dermatology and Venereology.
In the case series, InGeneron’s proprietary adipose-derived regenerative cell (ADRC) technology was used for the treatment of chronic venous leg ulcers and mixed arterial-venous ulcers, the most common types of chronic leg wounds in the Western world, especially among elderly patients. Both conditions are associated with severe pain impairing quality of life and complex as well as time-consuming treatment regimes.
The case series was conducted in collaboration with the Department of Dermatology at the University Hospital rechts der Isar Munich, led by principal investigator Alexander Konstantinow, and was published in the Journal of the European Academy of Dermatology and Venereology. The publication is titled “Therapy of ulcus cruris of venous and mixed venous arterial origin with autologous, adult native progenitor cells from subcutaneous adipose tissue: a prospective clinical pilot study”.
“Chronic leg wounds are associated with a complicated disease progression and severe pain, impairing quality of life. Current treatment options are complex, time consuming and require high medical expenses. New therapeutic interventions that improve outcomes in these patients could have an important therapeutic impact,” said Konstantinow, senior physician at the Department of Dermatology and Allergology at Technical University Munich, Germany, and the primary investigator of the study. “The results that we have achieved in this case series are remarkable because we have been able to restore wound healing capabilities and decrease pain in multimorbid patients with large venous and mixed arterial-venous ulcers with a one-time minimally invasive application, while demonstrating a very good safety and tolerability profile. InGeneron’s point-of-care system has the potential to benefit a large number of patients with wound healing disorders of vascular origin, while being more cost effective compared to currently available standards of care.”
The case series comprised 16 multimorbid leg ulcer patients (12 male, four female) ranging in age from 52 to 84 years who were treated with autologous ADRCs prepared at point-of-care with InGeneron’s Transpose RT system. Seven patients were presenting with venous leg ulcers, nine with mixed arterial-venous ulcers. Within 10 to 25 weeks, 11 out of the 16 patients showed complete wound closure. All seven venous leg ulcers patients showed complete epithelialisation. Moreover, the group of venous ulcer patients reported significant pain decrease by more than 90% 14 days post-treatment. After nine to 44 months of follow-up across all patients, no severe side effects were observed, demonstrating good overall safety and tolerability of the therapy in this patient population.
“This case series marks the next step in our journey to establish clinical evidence of how adipose-derived regenerative cells impact inflammation and pain as well as support healing in chronic wounds,” said Ron Stubbers, President of InGeneron. “These encouraging results highlight the potential of our regenerative cell therapy approach in wound healing.”
Based on the results of the investigator initiated study InGeneron plans to initiate a FDA feasibility study in the USA in the near-term. The prospective, randomised, single-site study will investigate the safety and tolerability of InGeneron’s point-of-care regenerative cell therapy in venous leg ulcer patients.