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1.  A Phase I Study of Human Cord Blood-Derived Mesenchymal Stem Cell Therapy in Patients with Peripheral Arterial Occlusive Disease 
Background and Objectives
Half of patients with critical limb ischemia (CLI) are ineligible for revascularization at diagnosis. The aim of this study was to assess the safety and feasibility of intramuscular human umbilical cord blood-derived mesenchymal stem cell (hUCB-MSC) therapy in patients with CLI due to atherosclerosis obliterans (ASO) or thromboangiitis obliterans (TAO).
Methods and Results
A total of eight patients (all male, median age 52 years, range 31∼77) with CLI were enrolled in this phase I trial. All patients were considered ineligible for further revascularization to improve CLI. We injected 1×107 hUCB-MSCs per single dose intramuscularly into the affected limb. The primary end points of safety were occurrence of adverse events (procedure-related complication, allergic reaction to hUCB-MSCs, graft-versus-host disease, cardiovascular and cerebrovascular events) and improvement of symptoms/clinical parameters (healing of foot ulcer, ankle-brachial index, and pain-free walking distance). Angiogenesis was measured with conventional angiography and scored by an independent reviewer. There were four adverse events in three patients. One patient, developed whole body urticaria after injection on treatment day, which disappeared after one day of antihistamine treatment. The other adverse events included diarrhea, oral ulceration, and elevation of serum creatinine level; all conditions improved without treatment. Abnormal results of laboratory parameters were not detected in any patients. Three of four ulcerations (75%) healed completely. Angiographic scores increased in three of eight patients.
Conclusions
This phase I study demonstrates that intramuscular hUCB-MSC injection is a safe and well tolerated treatment for patients with end-stage CLI due to ASO and TAO.
PMCID: PMC3841002  PMID: 24298372
Stem cell; Cord blood; PAOD; Mesenchymal
2.  Characterizing a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 to be proposed as standard reference materials 
Journal of Ginseng Research  2013;37(1):124-134.
The authentication of the physico-chemical properties of ginsenosides reference materials as well as qualitative and quantitative batch analytical data based on validated analytical procedures is a prerequisite for certifying good manufacturing practice (GMP). Ginsenoside Rb1 and Rg1, representing protopanaxadiol and protopanaxatriol ginsenosides, respectively, are accepted as marker substances in quality control standards worldwide. However, the current analytical methods for these two compounds recommended by Korean, Chinese, European, and Japanese pharmacopoeia do not apply to red ginseng preparations, particularly the extract, because of the relatively low content of the two agents in red ginseng compared to white ginseng. In manufacturing fresh ginseng into red ginseng products, ginseng roots are exposed to a high temperature for many hours, and the naturally occurring ginsenoside Rb1 and Rg1 are converted to artifact ginsenosides such as Rg3, Rg5, Rh1, and Rh2 during the heating process. The analysis of ginsenosides in commercially available ginseng products in Korea led us to propose the inclusion of the (20S)- and (20R)-ginsenoside Rg3, including ginsenoside Rb1 and Rg1, as additional reference materials for ginseng preparations. (20S)- and (20R)-ginsenoside Rg3 were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of those isolated ginsenosides was achieved according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantification, and mass balance tests. The isolated ginsenosides showed 100% purity when determined by the three HPLC systems. Also, the water content was found to be 0.534% for (20S)-Rg3 and 0.920% for (20R)-Rg3, meaning that the net mass balances for (20S)-Rg3 and (20R)-Rg3 were 99.466% and 99.080%, respectively. From these results, we could assess and propose a full spectrum of physico-chemical properties of (20S)- and (20R)-ginsenoside Rg3 as standard reference materials for GMP-based quality control.
doi:10.5142/jgr.2013.37.124
PMCID: PMC3659618  PMID: 23717166
Panax ginseng; (20S)- and (20R)-ginsenoside Rg3; Physico-chemical property; Standard reference material; Documentation
3.  Over-expression of extracellular superoxide dismutase in mouse synovial tissue attenuates the inflammatory arthritis 
Experimental & Molecular Medicine  2012;44(9):529-535.
Oxidative stress such as reactive oxygen species (ROS) within the inflamed joint have been indicated as being involved as inflammatory mediators in the induction of arthritis. Correlations between extracellular-superoxide dismutase (EC-SOD) and inflammatory arthritis have been shown in several animal models of RA. However, there is a question whether the over-expression of EC-SOD on arthritic joint also could suppress the progression of disease or not. In the present study, the effect on the synovial tissue of experimental arthritis was investigated using EC-SOD over-expressing transgenic mice. The over-expression of EC-SOD in joint tissue was confirmed by RT-PCR and immunohistochemistry. The degree of the inflammation in EC-SOD transgenic mice was suppressed in the collagen-induced arthritis model. In a cytokine assay, the production of pro-inflammatory cytokines such as, IL-1β, TNFα, and matrix metalloproteinases (MMPs) was decreased in fibroblast-like synoviocyte (FLS) but not in peripheral blood. Histological examination also showed repressed cartilage destruction and bone in EC-SOD transgenic mice. In conclusion, these data suggest that the over-expression of EC-SOD in FLS contributes to the activation of FLS and protection from joint destruction by depressing the production of the pro-inflammatory cytokines and MMPs. These results provide EC-SOD transgenic mice with a useful animal model for inflammatory arthritis research.
doi:10.3858/emm.2012.44.9.060
PMCID: PMC3465746  PMID: 22718219
arthritis, experimental; reactive oxygen species; rheumatoid arthritis; superoxide dismutase; synovial membrane
4.  Prevalence and Correlates of Depressive Symptoms among North Korean Defectors Living in South Korea for More than One Year 
Psychiatry Investigation  2009;6(3):122-130.
Objective
This study examined the prevalence and correlates of depressive symptoms in North Korean defectors who have been living in South Korea for more than one year.
Methods
We used questionnaires developed by the authors to collect sociodemographic data in addition to the Center for Epidemiologic Studies Depression Scale (CES-D), the Psychosocial Well-being Index to measure stress, and a social support scale. A total of 367 subjects were included in this study.
Results
The results showed that 30.5% of the men and 34.7% of the women reported depressive symptoms, and 33.1% of the men and 36.1% of the women exhibited signs of severe distress. Correlates of depressive symptoms were lack of occupation [odds ratio (OR)=2.198, 95% confidence interval (CI), 1.247-3.873], having escaped without family (OR=1.725, 95% CI, 1.006-2.959), and a poor subjective sense of health status (OR=3.111, 95% CI, 1.591-6.085).
Conclusion
Continuing vocational training and career management, psychological support programs, and intensive physical health services are needed to improve the mental health of this population.
doi:10.4306/pi.2009.6.3.122
PMCID: PMC2796059  PMID: 20046386
Depressive symptoms; Correlates; North Korean defectors

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