Hyalopaste… Aids bone marrow stem cell treatment for cartilage tissue regeneration and prevents bone marrow loss.
Invossa injection, previously used to treat knee osteoarthritis, was suspended from sales and manufacturing by the Ministry of Food and Drug Safety on March 31, 2019, sending shockwaves through the industry.
This suspension stemmed from safety concerns stemming from differences between the cells submitted by Kolon Bioengineering at the time of approval and the cells actually used in the treatment.
Amidst this situation, Miracell, the only company to have achieved a new medical technology using autologous bone marrow stem cell therapy for patients with cartilage defects, has been attracting attention for being the first in Korea to obtain import approval for its bone scaffold, a biomaterial graft used in conjunction with bone marrow stem cells, and for its safest treatment approach.
Miracell’s “HYALOFAST” has been approved by the Ministry of Food and Drug Safety (Approval No. 12-1205) pursuant to Article 15 of the Medical Devices Act and Article 18, Paragraph 3 of the Enforcement Decree of the same Act. It is an absorbable support material that aids in the establishment of bone marrow stem cells and prevents bone marrow loss during bone marrow stem cell treatment for cartilage tissue regeneration.
Unlike conventional film-based scaffolds, Hyalofast utilizes a 3D porous fibrous tissue. Bone marrow stem cells nestle in the interstitial spaces between the fibers, interacting with mesenchymal stem cells without the need for additional fixation. This promotes adhesion and viability, and enables cell differentiation to regenerate osteochondral defects.
The surgery involves making a minimal incision in the patient’s knee, identifying the cartilage defect, and inserting the stem cell therapy.
Compared to artificial joint surgery, the surgery takes less time and regenerates the patient’s own cartilage, reducing the risk of side effects. Recovery is also rapid, with patients able to return to the hospital after 3-5 days of postoperative rehabilitation.
After discharge, patients undergo rest and rehabilitation for three months, with normal activities resumed after six months.
Almost all patients with severe knee arthritis with worn cartilage fail to regenerate with normal articular cartilage with conventional treatments, resulting in unsatisfactory short- and long-term outcomes. However, patients receiving stem cell therapy are highly satisfied with the treatment, and the popularity of stem cell therapy is increasing due to its efficacy and safety.
Furthermore, stem cell therapy is widely used beyond the knee joint, including the ankle, and its use is expected to expand to other joints, such as the shoulder, providing promising news for patients suffering from related conditions.