Musculoskeletal Advanced Therapies
Despite the high incidence of muscle injuries, degenerative joint or spine diseses and other musculoskeletal disorders like tendon or bone pathologies, the basic issue - biological regeneration - has not yet been solved in clinical practice. Since 2006 we have been working on translational therapies in the field of musculoskeletal regeneration with the aim to bring innovative regenerative approaches to the patient.
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Research and development of Musculoskeletal Advanced Therapies
Muscle injuries are very common, occurring not only as sports injuries but also as a result of the exposure of deeper structures during surgical procedures. The consequences for the affected patients are often serious, such as severe physical impairment like limping or pain. Our reserach focuses therfore on clinical translation of somatic cell therapy for muscle regeneration.
It is also well-known that immune cells influence healing and regeneration in musculoskeletal tissues. We therefore aim at discovering new immunomodulatory therapeutic options for clinical translation of regenerative therapy approaches in the field of bone healing.
Clinical translation of somatic cell therapy for muscle regeneration
Based on comprehensive preclinical work on the effect of PLX-PAD on muscle regeneration after injury, we conducted a phase I/II study in cooperation with the BioTech enterprise Pluristem. To influence the recovery of hip fracture patients even more positively, we have continued our research focusing on the regeneration of muscle tissue. Therefore, we are currently conducting an international multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy of intraoperative intramuscular injections of PLX-PAD. The research also includes the investigation of stress reactions with the aim of stratifying patients for future therapies. The EU Horizon 2020 program funds this research named HIPGEN project. In parallel we are also preparing further clinical studies aimed at other musculoskeletal indications.
Clinical translation of regenerative therapy approaches in the field of bone healing
Inflammation is an immediate localized initiating response to tissue injury, which prepares the tissue for eventual repair and healing. This inflammatory reaction is necessary for healing but should be short-lived in order to obtain the desired response. However, it can be prolonged or too excessive and result in an inverse effect-tissue damage (Schmidt-Bleek et al. 2012b). This leads to additional burdens on the patient (pain, infection and surgical risk). A key to solving this problem might be the accumulation of naive, pro-regenerative cells in musculoskeletal tissues for their bone healing-promoting potential. We therfore aim at discovering new immunomodulatory therapeutic options.
Furthermore, we are currently developing a combined approach consisting of a drug and a biological glue to improve the effectiveness of fracture healing. The main objective is to establish a safe and efficient method to administer a previously pre clinically tested drug locally in a fibrin matrix for proximal humeral fracture healing.