Injections instead of joint replacement? Korean-made stem cell device still 'being tested' in Europe for a third year

[Financial News] Could end-stage knee arthritis, once said to have no option other than joint replacement surgery, be managed with injection therapy? Austrian medical professionals have been testing that possibility for a third year using a Korean-made stem cell extraction device.
Miracell said on the 12th that the research team led by Dr. Patrick Weninger at Avancell Medical & Sports Medical Center in Vienna, Austria, had published a clinical paper each year from 2024 through this year in international journals, using the company's stem cell extraction system, 'SMART M-CELL.' SMART M-CELL has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The first paper was published in 2024 in the Orthopedics and Rheumatology Open Access Journal. The research team administered a single intra-articular injection of autologous peripheral blood stem cells and exosomes extracted using SMART M-CELL to 39 patients (45 knees) with end-stage knee osteoarthritis classified as grade 4 on the Kellgren-Lawrence Classification. Six months later, patients' pain scores on the Visual Analog Scale (VAS) and functional scores on the KOOS had improved significantly, and magnetic resonance imaging (MRI) showed a reduction in bone marrow edema. No patients underwent joint replacement surgery during the follow-up period.
The second study, published in the Journal of Surgery in 2025, involved 25 patients with end-stage knee osteoarthritis. The research team compared a group injected with stem cell concentrate alone with a group that also received a liquid collagen scaffold. The combination group showed greater improvements in KOOS pain and function scores, and a more pronounced reduction in levels of MMP-13, a biomarker of cartilage breakdown.
The third study, published this year in the Indian Journal of Orthopaedics, expanded the focus to knee ligaments. Forty-seven patients whose anterior cruciate ligaments (ACLs) had been torn by trauma received an ultrasound-guided injection directly into the tear site of blood stem cells (BSC) extracted using SMART M-CELL and platelet-rich plasma (PRP), mixed together, instead of undergoing surgery. At the 12-month follow-up, functional scores (IKDC and Lysholm) averaged at least 93 points, while the pain score (VAS) fell to 0.36 points. There were no re-tears during the follow-up period, and most patients returned to their pre-injury activity levels. An MRI at three months showed signs of recovery in the ligament structure.
However, all three studies involved between 25 and 47 patients. The first and third studies compared outcomes before and after treatment without control groups, so larger randomized controlled trials are needed to establish the treatment's effectiveness.
A Miracell representative said, "Over three years, Austrian medical professionals have expanded the scope of SMART M-CELL's applications, from treating end-stage arthritis to ligament regeneration," adding, "We expect it to become a new option for non-surgical regenerative treatment for patients who find surgery burdensome." 


[email protected] Jung Myung-jin, Medical Correspondent Reporter