Safety Assessment
cerebral hemorrhage, neoplasia, allergic reactions, declines in renal function
CEREBRAL HEMORRHAGE, ALLERGIC REACTION, DISEASE COURSE, ADVERSE EVENTS, NEOPLASIA, DISEASE, EVENTS, HYPERTENSION
Three periods were monitored for safety: (1) acute events related to the invasive procedures, (2) acute post-SFV infusion systemic reactions, and (3) long-term clinical events after SVF infusion. Lipoaspirates, transaortic catheterization of the renal arteries, and SVF cell infusions were all performed with no adverse events attributed to the procedures. No allergic reactions were noted.Ten patients entered the study in advanced stages of CKDu. Of those, 3 patients in stage 5 died at 20, 24, and 28 months, respectively. The first patient succumbed to a cerebral hemorrhage at 20 months, while the other 2 patients in stage 5 died from further deterioration in their renal function. Review of these cases by the chief MINSA nephrologist (not a member of the study team) revealed no treatment-related mortality given the underlying stage of their disease. Progressive declines in renal function in stage 4 and 5 CKDu patients were consistent with known disease course. No other chronic adverse events (hypertension or evidence of neoplasia within the kidney parenchyma) occurred during the 36 months post-treatment.