Maintenance of the synergistic effects of cord blood cells and erythropoietin combination therapy after additional cord blood infusion in children with cerebral palsy: 1-year open-label extension study of randomized placebo-controlled trial.

BACKGROUND: This 1-year open-label extension study aimed to identify the persistent synergistic effects of allogeneic umbilical cord blood (UCB) cells and erythropoietin (EPO) in children with cerebral palsy (CP) for up to 2 years. METHODS: This open-label extension study followed children with CP who were enrolled in the previous randomized, double blind, placebo-controlled trial. The following groups from the first trial were maintained: (A) UCB + EPO, (B) UCB, (C) EPO, and (D) only placebo, and all the participants had continued active rehabilitation. This extended study started 3 months after termination of the first trial, which had a 1-year follow-up duration. All subjects received single additional UCB intravenous infusion at the extension baseline regardless of their initial allocation. Outcome measures were the gross motor performance measure (GMPM), gross motor function measure-66 (GMFM-66), and Bayley scales of infant development-II (BSID-II), which were followed at 3, 6, and 12 months after the extension baseline. Changes in the outcome scores from the baseline values of the previous trial and this study were analysed. RESULTS: Sixty-nine children (4.29 ± 1.28 years, M:F = 34:35) were included in this study. Each group showed improvements in the outcome measures at 12 months after additional UCB infusion compared to the baseline scores, except for GMFM and GMPM in Group C which were elevated at 3 and 6 months post-therapy. Total subject analyses did not show significant differences in the outcome measures between the four different groups at 3, 6 and 12 months after additional UCB therapy. However, patients with severe dysfunction, whose GMFCS levels were IV and V, revealed a larger improvement of the GMPM score in Group A than in Group D (Ps < 0.05) from the baseline value of the previous trial. The changes in BSID-II mental scale scores were positively correlated with the number of administered total nucleated cells per unit body weight during this one-year extension study period (r = 0.536, P = 0.001). CONCLUSIONS: These results suggest that when administering UCB to treat patients with CP, combination therapy with EPO is more effective, and the effect might last as long as 2 years, especially in patients with severe impairments. TRIAL REGISTRATION: CHA Bundang Medical Center IRB, No. 2015-06-093, approved on July 29, 2015, ( https://www.e-irb.com:3443/devlpg/nlpgS200.jsp ), ClinicalTrials.gov, NCT03130816, retrospectively registered on April 27, 2017 ( https://clinicaltrials.gov/ct2/show/NCT03130816?term=NCT03130816&draw=2&rank=1 ).

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study.

Objective: This study was conducted to demonstrate the safety and usability of an immersive virtual reality (VR) game as a rehabilitative training by assessing adverse events (AEs), adherence, and satisfaction in patients with brain injury who had free optional opportunities. Materials and Methods: The results were analyzed retrospectively. Seventy-eight patients with brain injury, undergoing rehabilitation treatment for motor impairment, were recruited. Among them, 51 were available for postintervention survey. The immersive type of VR training was programmed to facilitate use of the paralyzed upper extremity through a fishing simulation game. The Oculus Rift was used as head-mounted display device. Patients were observed for any AEs as defined in the Common Terminology Criteria for AEs during and after each VR training session. A postintervention telephone survey was done to investigate adherence-related factors and safety. Results: The results were analyzed after dividing the patients into nonadherence (patients participated <3 times) and high-adherence (≥3 times) groups. No serious AEs were reported during and after the VR training, and several patients reported other AEs, predominantly dizziness, with one case requiring cessation of VR training. Overall, the satisfaction rate was 54%. Compared with the nonadherence group, the high-adherence group expressed higher satisfaction with VR training, regarded it as effective for recovery from upper limb paralysis, accepted VR as comprehensible, and considered the level of difficulty to be appropriate (P < 0.05). Conclusion: Immersive VR training appeared to be safe for patients with brain injury.

Efficacy of Cord Blood Cell Therapy for Hutchinson-Gilford Progeria Syndrome-A Case Report.

Hutchinson-Gilford progeria syndrome (HGPS) is an extremely rare premature aging disorder characterized by short stature and atherosclerosis-induced death within teenage years. A 13-year-old male diagnosed with HGPS was administered three intravenous infusions of allogeneic cord blood (CB) cells from unrelated donors at four-month intervals to evaluate the safety and its therapeutic efficacy. Adverse events were monitored in addition to height, weight, laboratory blood tests, joint range of motion (ROM), and carotid Doppler. Cytokine and receptor assays were also performed. The patient exhibited an increase in growth rate for both height and weight. One year after therapy initiation, evident amelioration in pulse wave velocity, bilateral maximal intima-media thickness, and dyslipidemic status were observed, which were in abrupt aggravation prior to treatment. Further, an increase in flexibility occurred in some joints of the upper extremities. No serious adverse events were observed throughout the study period and one year beyond. A molecular assay revealed downregulation of proinflammatory and atherosclerosis, representing cytokine expressions following the administration of CB cells. This is the first reported case of an allogeneic CB trial in a patient with HGPS showing therapeutic effects of CB with improvements in anthropometric measures, joint ROM with amelioration of atherosclerosis, and dyslipidemia induced by anti-inflammatory and anti-atherosclerotic responses.

Environmental Applications of Nano-Sized Recycled Aggregates: The Effect of Sterilization and Adsorption.

To evaluate the sterilize efficiency of nano-sized recycled aggregates (RAs), several types of RAs were examined for the purpose of environmental stamping out procedure. The poultry (e.g., chicken) was selected as a target livestock of epidemic disease, and the blast furnace slag (BFS), fly ash (FA), slaked lime (SL), nano-cerium (n-Ce) and shell (Sh) were used as the RAs materials. The fermented solution of effective microorganisms (EM) was added to decompose the target livestock. Various kinds of lab-scale reactor were operated to examine the effects of RAs volume; high and low volume of RAs (e.g., 1.89 w/v% and 1.14 w/v% of RA in solution, respectively), and the effects of EM concentration (e.g., concentrated solution (100%) and diluted solution (12.5%)) with tested in different reaction time. The number of microorganisms after batch tests was counted for the sterilized effects of RAs, and organic matters (e.g., chemical oxygen demand (COD)) and inorganic matters (e.g., suspended solids (SS), heavy metals and potential ions) were analyzed before and after adsorption process. The cases of SL and n-Ce showed high removal of microorganism in the batch of high concentrated EM for 20 days. However the other RA materials were less effective on the sterilization especially in lower volume of RAs. In diluted EM (e.g., 12.5%) tests, most RAs have high sterilization efficiencies in the short periods of batch reaction regardless of RAs types, and it was more effective with longer reaction time. The BFS and n-Ce exhibited higher surface area than others and they adsorbed highly heavy metals in water. The results suggested that the concentration of target organism was the most important to determine sterilization and adsorption properties of RAs.