A paper regarding a clinical study using our cultured supernatant has been published in the journal PLoS One.

It has been reported that systemic administration of the conditioned medium (CM) derived from human adipose tissue (AD) and human umbilical cord tissue (UC) mesenchymal stromal/stem cells (MSCs), manufactured using our technology, safe and have anti-inflammatory effects.

Inflammation, especially chronic inflammation, is closely related to various diseases and is a very important phenomenon/state that can also contribute to cancer and aging.

Recently, the results of four observational studies (heart failure, lung disease, fatigue, chronic renal failure) conducted at Seihoku Clinic, Medical Corporation Keiseikai, using CM derived from AD- and UC-MSC manufactured using our cell culture technology, were published in the peer-reviewed scientific journal PLoS ONE, particularly regarding safety. Like MSCs, CM is expected to be effective against various intractable diseases, and many research papers have been reported. In these four observational studies, systemic administration of AD- and/or UC-CM was performed three times at one-month intervals (a total of 162 times) to 54 patients via intravenous or arterial (direct administration from the vicinity of the affected area using a catheter) routes. Additionally, one patient with chronic fatigue received 12 administrations via inhalation at one-week intervals. No serious adverse events were observed in any of the administration methods or diseases. Four minor (Grade 1 or 2) adverse events were observed, but the causality with AD- or UC-CM administration was unclarified.

Furthermore, when examining the CRP (C Reactive Protein; released into the blood when inflammation occurs) in the serum of patients before and after administration of AD- and UC-CM, it was observed that the CRP values significantly decreased after administration in patients who were considered to have inflammation before administration (CRP > 0.3 mg/dL) (p = 0.012; two-tailed Wilcoxon matched-pairs signed-rank test). This result strongly suggests that inflammation was suppressed in patients with inflammation due to the administration of AD- and UC-CM.

These results are a clinical report that the safety and potential anti-inflammatory effects of systemic administration of MSC-CM manufactured using AOF technology in humans were demonstrated with a certain degree of certainty.