Preeclampsia affects 3-8% of all pregnancies worldwide, thus being the main cause of fetal-maternal mortality and morbidity worldwide. Preeclampsia is associated to Fetal Growth Restriction. Importantly, even though Preeclampsia resolves at delivery with placenta removal, it causes severe long term complications for both the mother and the newborn as cardiovascular and metabolic diseases, diabetes, neonatal neurological impairment, cerebral palsy and an increased risk of intellectual disability and autism spectrum disorders. It is evident that Preeclampsia has a massive social-economic burden, costing to the global health care system more than 3 billion USD/year with lifetime medical intervention. There are no effective therapeutic interventions for Preeclampsia except for a timed and often premature delivery, that represents itself an important risk factor for the newborn's health.
Our technology is based on human PDMSCs purified from the human term placenta immediately after delivery, expanded and cultured in vitro in order to naturally obtain our preeclampsia therapeutic biological named CB-ChMF-11.
We recently successfully completed a Proof of Concept study to verify in-vivo on a recognized Preeclampsia animal model the efficacy and sustainability of our innovative therapeutic approach. CB-ChMF-11 reverted maternal hypertension and proteinuria as well as it significantly improved fetal outcome. Moreover, we reported CB-ChMF-11 beneficial effect also on the PE mice placenta after the in-vivo administration. In particular, CB-ChMF-11 significantly inhibited the placental production of detrimental molecules pivotal for preeclampsia onset.
A new drug for Preeclampsia represent both an important improvement for the health of millions of mothers and children and a substantial saving for sanitary systems in developed countries. The very positive outcome of the proof of concept study strongly supports CB-ChMF-11 as a key improvement for the therapy of preeclampsia, which is still an unsolved medical enigma. We are now entering in the Pre-clinical trial phase.
CB-ChMF-11 therapeutic approach for Preeclampsia is patented in EU and is extended in North America and Japan.