• Cytori Therapeutics Inc., of San Diego said the first patient was enrolled in a Japanese investigator-initiated safety and feasibility study using adipose-derived stem and regenerative cells to treat stress urinary incontinence. The 10-patient study uses Cytori's Celution 800 System to process and extract the patients' own adipose tissue-derived stem and regenerative cells at the time of surgery. As part of the study, stem cells were injected intra-muscularly into the sphincter as well as in combination with a measured volume of the patient's own fat tissue to create a bulking agent to support the urethra. The study will evaluate safety, functional endpoints including intraurethral pressure and leak point pressure, as well as subjective assessments of patient and physician satisfaction.

• FibroGen Inc., of San Francisco, said patient recruitment has resumed in a Phase II study of FG-4592/ASP1517, an investigational oral hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor in development for the treatment of anemia associated with chronic kidney disease (CKD). The study is a single-blind, placebo-controlled, dose-escalation trial expected to enroll 130 patients with anemia of CKD who are not receiving dialysis. The objectives of the study are to characterize safety, pharmacokinetics and pharmacodynamics, of FG-4592/ASP1517 and to obtain exploratory efficacy data. Previously reported interim results from patients randomized to the first dose group showed that intermittent oral administration of FG-4592/ASP1517 for four weeks led to clinically relevant increases in hemoglobin concentration with induction of endogenous levels of erythropoietin that were within the normal physiologic range.