Safety Monitoring
bleeding, fever, hemorrhage, acute kidney ischemia, renal embolism
ADVERSE EVENTS, HEMORRHAGE, BLEEDING
Subjects were followed in the hospital for immediate adverse events related with the lipoaspiration procedure (eg, bleeding); renal artery catheterization (eg, renal embolism, hemorrhage); and SVF cell infusion (eg, anaphylactic reaction, fever, hemodynamic alterations, and acute kidney ischemia) for 24 hours. After discharge, patients were interviewed for adverse events daily by phone for 1 week, then weekly for a month.Subjects followed up in clinic for history, medication review, and physical exams at 2-, 4-, 6-, 12, 18-, 24-, 30-, and 36-months post-SVF treatment. Laboratory visits conducted during follow-up visits included: complete blood count, serum chemistry, urinalysis, and urine chemistry. All subjects had direct access to the clinical coordinating team by cell phone if needed. Follow-up clinic visits are summarized in 