KFDA approves biological therapy for cartilage regeneration

November 09,2018

Macquarie Stem Cells has provided this information to educate the public based on peer reviewed, published scientific and medical documents. We don’t aim to encourage consumers to seek out such treatments prior to an assessment by a health professional to determine your suitability for treatment. This is obtained directly from PubMed. There were no financial sponsors identified in this study. We aim to provide you with an unbiased range of treatments that are available aside from biological therapy, This is discussed in ‘other-options’  page on our website.

When it comes to approval of biological therapies, there are a few countries that are stepping in and taking the lead. At this stage, one of those regulatory bodies is the Korean Food and Drug Administration (KFDA).
It appears the KFDA is keen to advance medicine quickly, so they have taken action and approved the use of biological therapies for treating osteoarthritis and cartilage regeneration.
Upon reading the published abstract below by Dr. J. Pak, we find ourselves questioning our systems.
Australia, why is it taking so long to get formal approval?
Are we really behind the rest of the world?

TITLE: “Clinical Protocol of Producing Adipose Tissue-Derived Stromal Vascular Fraction for Potential Cartilage Regeneration” (Pak et al., 2018)

Published: 29th Sep 2018
Journal of Visualised Experiments


“Osteoarthritis (OA) is one of the most common debilitating disorders. Recently, numerous attempts have been made to improve the functions of the knees by using different forms of mesenchymal stem cells (MSCs). In Korea, bone marrow concentrates and cord blood-derived stem cells have been approved by the Korean Food and Drug Administration (KFDA) for cartilage regeneration. In addition, an adipose tissue-derived stromal vascular fraction (SVF) has been allowed by the KFDA for joint injections in human patients. Autologous adipose tissue-derived SVF contains extracellular matrix (ECM) in addition to mesenchymal stem cells. ECM excretes various cytokines that, along with hyaluronic acid (HA) and platelet-rich plasma (PRP) activated by calcium chloride, may help MSCs to regenerate cartilage and improve knee functions. In this article, we presented a protocol to improve knee functions by regenerating cartilage-like tissue in human patients with OA. The result of the protocol was first reported in 2011 followed by a few additional publications. The protocol involves liposuction to obtain autologous lipoaspirates that are mixed with collagenase. This lipoaspirates-collagenase mixture is then cut and homogenized to remove large fibrous tissue that may clog up the needle during the injection. Afterwards, the mixture is incubated to obtain adipose tissue-derived SVF. The resulting adipose tissue-derived SVF, containing both adipose tissue-derived MSCs and remnants of ECM, is injected into knees of patients, combined with HA and calcium chloride activated PRP. Included are three cases of patients who were treated with our protocol resulting in improvement of knee pain, swelling, and range of motion along with MRI evidence of hyaline cartilage-like tissue.”(Pak et al., 2018)


REF: Pak, J., Lee, J., Pak, N., Park, K., Jeon, J., Jeong, B. and Lee, S. (2018). Clinical Protocol of Producing Adipose Tissue-Derived Stromal Vascular Fraction for Potential Cartilage Regeneration. Journal of Visualized Experiments, (139).

TAGS: Macquarie Stem Cells, Possibilities of Biological Treatments, Focusing on Osteoarthritis, Macquarie Stem Cells treating osteoarthritis, Dr. Ralph Bright biological treatment, KFDA approves biological medicine


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