OrthoSera GmbH recently announced that the pilot clinical study for their hyperacute serum therapy, hypACT, shows promise for treating osteoarthritis by reversing inflammation and inducing cartilage and bone marrow turnover.
New Therapy on the Horizon for Osteoarthritis
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#osteoarthritisSecondary#hypact#orthosera
The study included 36 patients with intermediate-stage knee osteoarthritis. The proprietary blood derivative was produced at the bedside of each patient with the CE-marked hypACT inject autologous device and then administered into the knee joint.
The patients received three consecutive injections and then afterwards the researchers measured the synovial cytokine patterns, performed MR imaging and measured patient-reported outcomes. The primary goal of the study was to analyze the cytokine change of the synovial fluid.
The researchers reported that they found clear patterns that relate to the etiology of the disease. According to the data, the patients 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” said Dr. Zsombor Lacza, Founder and CEO of OrthoSera.
“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 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.
OrthoSera is a commercial-stage regenerative medicine company with headquarters in Krems an der Donau, Austria and subsidiaries in the U.S. and Hungary.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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