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Featured Advanced Cell Therapy Trial: Metabolic Syndrome
During February 2017, 49 new clinical trials were registered worldwide that perform advanced cell therapy. These trials meet the EMA definition of ATMP or the FDA definition of 351 HCT/P. The new February trials are 63% regenerative medicine and 37% immunotherapy. The fraction of the February trials that are not listed on ClinicalTrials.gov is 18%.
At CellTrials.org, we have launched a subscription service of providing clients with monthly trials updates. So far in 2017 there were 45 new trials in January and 49 in February, so if this rate keeps up the year’s total may exceed 550. The total number of advanced cell therapy trials in 2016 was 582, up 30% over 2015, in large part due to the rapid rise of CAR-T trials in 2016.
We have also decided to periodically feature an interesting trial. Our first featured trial is NCT03059355: “Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Bone Marrow (BM) Derived MSCs to Evaluate Cytokine Suppression in Patients With Chronic Inflammation Due to Metabolic Syndrome. (CERES)”. This trial is not yet recruiting, but will be conducted at the University of Miami Miller School of Medicine under principal investigator Joshua M. Hare, MD.
This trial caught our attention because it is only the 3rd time that perinatal cells (in this case MSC from umbilical cord tissue) have been used in a registered clinical trial that targets changes associated with aging.
The two previous trials both targeted the condition frailty syndrome. Trial NCT02065245 was registered in 2014 by Hare's group at the U. of Miami, was named CRATUS, and the active cells are described as "allogeneic human MSC", which are from umbilical cord tissue. The outcomes of this trial will be published in spring 2017. Trial NCT02418013 was registered in 2015 at Bundang CHA hospital in South Korea and the active cells are umbilical cord blood and plasma.
This month’s new trial looks at Metabolic syndrome, which is not the same as aging but is more common in older adults. Metabolic syndrome is present when a patient has at least three of these five conditions:
Close to one quarter of adults in the United States have metabolic syndrome, which places them at higher risk of cardiovascular disease, diabetes, and stroke. The underlying causes of metabolic syndrome include obesity, physical inactivity, genetic factors and aging.
If an infusion of MSC can suppress chronic inflammation due to metabolic syndrome, this could be a blockbuster application for MSC. We will be curious to follow the progress of this trial.