Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE®: a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial.

OBJECTIVE: To evaluate the safety and efficacy of intra-articular (IA) injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE® for knee osteoarthritis. METHODS: This was a patient-blind, randomized, active-control trial consisted of 4 arms including hyaluronic acid (HA) control and 3 ELIXCYTE® doses. A total of 64 subjects were screened, and 57 subjects were randomized. The primary endpoints included the changes from baseline to post-treatment visit of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 24 and the incidence of adverse events (AEs) and serious adverse events (SAEs). RESULTS: No ELIXCYTE®-related serious adverse events were reported during 96 weeks of follow-up and no suspected unexpected serious adverse reaction (SUSAR) or death was reported. The changes of the primary endpoint, WOMAC pain score at Week 24, showed significant differences in all ELIXCYTE® groups, as well as in HA groups between post-treatment visit and baseline. The ELIXCYTE® groups revealed significant decreases at Week 4 compared to HA group in WOMAC total scores, stiffness scores, functional limitation scores suggested the potential of ELIXCYTE® in earlier onset compared to those from HA. The significant differences of visual analog scale (VAS) pain score and Knee Society Clinical Rating System (KSCRS) functional activities score at Week 48 after ELIXCYTE® administration suggested the potential of ELIXCYTE® in the longer duration of the effectiveness compared to HA group. CONCLUSIONS: ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02784964. Registered 16 May, 2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02784964.

Cataract and refractive surgery in ; a survey of KSCRS members from 1995~2006.

PURPOSE: This purpose of this report was to study trends in cataract and refractive surgeries conducted during the past twelve years and to compare results to previous reports from the ASCRS and New Zealand (NZ) in order to forecast future medical services. METHODS: We surveyed members of the Korean Society of Cataract and Refractive Surgery (KSCRS) every year from 1995 to 2006, and studied changes in cataract and refractive surgeries (RS). RESULTS: The duration of hospitalization has been gradually decreasing to the point that a one day hospitalization following surgery has become common. The rate of topical anesthesia use has significantly increased since 1998. Sutureless incision methods are now commonly practiced. The use of acryl IOL as an optic material has been gradually increasing for cataract surgeries. KSCRS members showed an interest in the special intraocular lenses as multifocal IOL. While Excimer laser PRK was the most popular refractive surgery during the first stage, KSCRS members increasingly prefer LASIK to the Excimer laser PRK. Regression of the corrected visual acuity, dry eye, night halo, and flashes were the most common complications following refractive surgeries. Medical disputes related to PRK and LASIK have been gradually increasing throughout the study period. CONCLUSIONS: We confirm that the KSCRS practice styles for cataract and RS are similar to those of the ASCRS and NZ. We infer a world-wide trend from the comparison of these three societies.