Hyperacute serum therapy: pilot first-in-man results in knee osteoarthritis
OrthoSera GmbH, an orthobiologics company developing serum-based solutions for musculoskeletal indications announces results of its first-in-man pilot clinical study of hyperacute serum on 36 patients in knee osteoarthritis. The proprietary blood derivative is produced at the bedside with the CE-marked hypACTTM inject autologous device and administered into the knee joint. Researchers at Semmelweis University in Budapest have designed a human joint model by explanting osteoarthritic bone, cartilage and synovial membrane and were able to show that hyperacute serum administration reversed the inflammatory state and induced cartilage and bone marrow turnover. This experiment provided the missing link between classical cell cultures and clinical observations and provided rationale for a pilot clinical study. Patients with intermediate-stage knee osteoarthritis received three consecutive injections of hyperacute serum in their affected knee joints and followed-up by measuring the synovial cytokine patterns, MR imaging and patient-reported outcomes. The primary goal was investigating the cytokine changes of the synovial fluid: the researchers found clear patterns that relate to the etiology of the disease. Patients responded well to the treatment and improved by an average 18 points on the Knee Injury and Osteoarthritis Outcome Score (KOOS) at six months. "We are encouraged by this pilot data set and will continue clinical development" says Dr. Zsombor Lacza, Founder and CEO. “This was a huge undertaking and required us to measure basically all possible synovial cytokines that can play a role in osteoarthritis. The effort payed back with exciting new knowledge, as we were able to identify specific patient subgroups which can ultimately lead to targeted serum protocols that have a reliable response in knee osteoarthritis.”
Preclinical results have been accepted for publication in prestigious peer-reviewed journals ‘Stem Cells International’ and ‘Regenerative Medicine’. Pilot clinical data will be presented in mid-December at the International Cartilage Regeneration & Joint Preservation Society’s Focus Meeting – ‘I am NOT Ready for Metal’ in Milan, Italy.