Miracell's SMART M-CELL Featured in Clinical Study Demonstrating Improved Pain and Knee Function in Severe Osteoarthritis

• Austrian research team led by Dr. Patrick Weninger evaluates Miracell's SMART M-CELL technology in a six-month follow-up study
• Statistically significant improvements observed in VAS pain scores and all KOOS knee function subscales

SEOUL, South Korea, Oct. 22, 2026 /PRNewswire/ -- Miracell Co., Ltd., a South Korean regenerative medicine company, has highlighted findings from a clinical study led by an Austrian orthopedic research team, which reported significant improvements in pain and knee function among 39 patients with severe Grade IV knee osteoarthritis following a single injection of autologous blood-derived cellular components processed using the SMART M-CELL system.

The study utilized SMART M-CELL, Miracell's proprietary cell harvesting and concentration technology, to isolate and concentrate stem cells and stem cell-derived exosomes from patients' peripheral blood for intra-articular injection. Over a six-month follow-up period, researchers observed notable symptom relief and functional gains among participants, all of whom had previously been recommended for total knee replacement surgery.

The findings were published in June 2024 in the Orthopedics and Rheumatology Open Access Journal under the title, "A Single Injection of Autologous, Peripheral Stem Cells Combined with Stem-Cell Derived Exosomes Significantly Improves Symptoms in Patients with Severe Grade-IV Osteoarthritis of the Knee," led by Austrian orthopedic specialist Dr. Patrick Weninger.

The study included 39 patients with Grade IV knee osteoarthritis (involving 45 knee joints) who received treatment between March and December 2023. Grade IV osteoarthritis represents an advanced stage of cartilage degeneration, characterized by severe pain and functional limitations that typically warrant total knee replacement surgery. All enrolled patients had previously been advised to undergo total knee arthroplasty but sought alternative non-surgical options.

Single Injection Using SMART M-CELL to Harvest Autologous Blood-Derived Cells

Using SMART M-CELL, researchers processed venous blood collected from each patient via centrifugation to isolate and concentrate stem cells and exosomes. The resulting cellular components were combined and administered as a single, ultrasound-guided intra-articular injection into the affected knee joint.

Pain levels and knee function were evaluated before treatment and six months post-procedure. According to the study, all patients demonstrated measurable improvements in symptoms associated with knee osteoarthritis.

Visual Analog Scale (VAS) scores, used to assess pain intensity, decreased significantly compared to baseline. Significant gains were also observed across the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated assessment tool for knee-related symptoms and function. Statistically significant improvements were reported across all five KOOS subscales: pain, symptoms, activities of daily living (ADL), sports and recreational activities, and knee-related quality of life (QoL).

At the six-month follow-up, no patients reported unchanged or worsened symptoms, and all participants expressed satisfaction with their treatment outcomes.

MRI Findings Indicate Improvements in Bone Marrow Edema

Beyond patient-reported pain reductions, the study documented visible structural changes via medical imaging. MRI examinations of 11 patients revealed improvements in bone marrow edema six weeks post-treatment. Bone marrow edema refers to fluid accumulation within bone tissue surrounding a joint and is strongly associated with pain and structural degeneration in osteoarthritis patients.

The published study featured MRI images from a 79-year-old male patient, demonstrating a marked reduction in bone marrow edema in the medial compartment of the knee following treatment. Researchers suggested that the anti-inflammatory and immunomodulatory properties of stem cells and stem cell-derived exosomes likely contributed to these reductions in pain and swelling.

Minimally Invasive Cell Harvesting Offers a Non-Surgical Treatment Approach

A key advantage of this therapeutic approach is the reliance on patients' own venous blood, eliminating the need for invasive cell harvesting procedures. Conventional therapies using bone marrow-derived stem cells require bone marrow aspiration, while adipose-derived cell therapies involve liposuction, both of which impose physical strain on patients. In contrast, the approach evaluated in this study requires only a standard venous blood draw, followed by rapid processing and injection.

The research team noted that this method offers a less invasive, more accessible strategy for both clinicians and patients. Regarding safety, no serious treatment-related adverse events were reported. Mild, temporary pain and swelling immediately following the injection were easily managed with conservative care.

Researchers concluded that these findings highlight the potential of peripheral blood-derived cellular therapy as an effective non-surgical alternative for severe knee osteoarthritis patients seeking to delay or avoid total joint replacement. However, they emphasized that as a relatively small study with a six-month follow-up, larger controlled trials with longer observation periods are required to fully establish long-term efficacy and safety.

A Miracell representative commented: "Grade IV knee osteoarthritis has long been considered a point of no return where joint replacement surgery is the primary option. These clinical findings demonstrate a novel possibility for meaningful symptom relief without surgery. Leveraging the clinical efficacy of SMART M-CELL validated in international orthopedic research, we aim to expand access to innovative regenerative therapies for patients with severe musculoskeletal conditions."

Miracell Expands into North American Regenerative Medicine and Longevity Markets

Meanwhile, Miracell has established its U.S. subsidiary, Miracell U.S. Inc., in California to accelerate its expansion into the North American regenerative medicine and longevity sectors. Through its U.S. operations, the company is establishing distribution networks, supplying SMART M-CELL systems, providing medical practitioner training, engaging Key Opinion Leaders (KOLs), and sponsoring collaborative clinical trials.

SMART M-CELL is an advanced Biologics Harvesting System designed to automatically isolate and concentrate CD34+ cells, growth factors, and key regenerative cell populations from peripheral blood and bone marrow.

Following a U.S. patent grant in 2024, SMART M-CELL secured U.S. Food and Drug Administration (FDA) 510(k) clearance in April 2026. The clearance encompasses the entire system, including the automated separation device and dedicated processing kits for blood and bone marrow.

SMART M-CELL integrates proprietary harvesting technology with Light Energy technology, enabling complete cell separation and concentration in approximately 20 minutes. The system optimizes critical parameters including cell recovery rate, purity, and viability, ensuring reproducible processing conditions for clinical institutions.

Currently utilized across medical specialties including orthopedics, pain management, dermatology, and plastic surgery, Miracell exports its systems to approximately 40 countries worldwide.

For more information, visit: https://www.miracell.co.kr/en/

SOURCE Miracell