1.The role of human umbilical cord mesenchymal stem cells in skin wound repair:A literature review
Xinyu LIU ; Mengmeng KONG ; Yi FU ; Jialin LAI ; Jun LI ; Jianghua SUN
The Journal of Practical Medicine 2025;41(21):3462-3466
Mesenchymal stem cells(MSCs)are multipotent stromal cells that possess the capacity for self-renewal and differentiation into multiple cell lineages.Due to the ease of procurement,robust expansion in vitro,the multipotency,they are recognized as a vital source of stem cells in the field of regenerative medicine.MSCs can be isolated from various tissues,including bone marrow,adipose tissue,and umbilical cord.Research indicates that Human umbilical cord mesenchymal stem cells(hUCMSCs)play an effective role in wound healing and tissue regeneration,and can be utilized for the repair of skin wounds.They are also considered to be the most promising seed cells for skin tissue engineering.This review aims to provide an overview of the biological characteristics of hUCMSCs,the mechanisms in promoting skin wound healing,and their clinical applications.
2.The role of human umbilical cord mesenchymal stem cells in skin wound repair:A literature review
Xinyu LIU ; Mengmeng KONG ; Yi FU ; Jialin LAI ; Jun LI ; Jianghua SUN
The Journal of Practical Medicine 2025;41(21):3462-3466
Mesenchymal stem cells(MSCs)are multipotent stromal cells that possess the capacity for self-renewal and differentiation into multiple cell lineages.Due to the ease of procurement,robust expansion in vitro,the multipotency,they are recognized as a vital source of stem cells in the field of regenerative medicine.MSCs can be isolated from various tissues,including bone marrow,adipose tissue,and umbilical cord.Research indicates that Human umbilical cord mesenchymal stem cells(hUCMSCs)play an effective role in wound healing and tissue regeneration,and can be utilized for the repair of skin wounds.They are also considered to be the most promising seed cells for skin tissue engineering.This review aims to provide an overview of the biological characteristics of hUCMSCs,the mechanisms in promoting skin wound healing,and their clinical applications.
3.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
4.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
5.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
6.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
7.Efficacy and safety of single high-dose versus multiple low-dose ATG-Fresenius induction in de novo renal transplantation
Liping CHEN ; Chunbai MO ; Jun TIAN ; Guanghui PAN ; Changxi WANG ; Jianghua CHEN ; Tao LIN ; Xiaodong ZHANG ; Yaowen FU ; Long LIU ; Zhishui CHEN ; Aimin ZHANG ; Minzhuan LIN ; Xuyong SUN ; Jinsong CHEN ; Hang LIU ; Shaoling ZHENG ; Tongyu ZHU ; Qingshan QU ; Bingyi SHI
Chinese Journal of Organ Transplantation 2017;38(11):665-670
Objective To evaluate the efficacy and safety of single bolus high dose (SD group) ATG-Fresenius induction therapy in kidney transplantation vs.multiple low dose (MD group) administration.Methods A multiple center,prospective,randomized and controlled clinical study was performed on 280 de novo renal transplant recipients from 19 centers.Patients were randomized into 2 groups as follows:SD group,a single high dose (7-9 mg/kg) of ATG-F infused as an induction agent before the vessel anastomoses;MD group,2 mg/kg of ATG-F daily administrated in postoperative 4 days.All the patients accepted maintenance immunosuppressive protocol including tacrolimus,mycophenolate and prednisone.Patients were assessed and data were collected at regular schedule clinic visits on the day 1,3,7,14,30,90,180,270 and 365.The primary end point of efficacy was therapeutic failure rate [the number of death,grafts loss and acute rejection (AR)].The event first occurred should be used in the classification of patients.The non-inferiority evaluation of the two treatment regimens was done based on treatment failure rate.The secondary end points of efficacy were the incidence of AR,delayed graft function (DGF),1-year survival rate of patients and grafts,and serum creatinine at each visiting point.The indicators for safety evaluation included hemotologic variation and incidence of adverse events.Results The therapeutic failure rate in SD group was non-inferior to the MD group (17.24% vs.23.08%).AR was the major cause of therapeutic failure and there was similar incidence of AR between SD gronp and MD group (12.07% vs.21.37%).There was no significant difference in the incidence of DGF between SD group and MD group (12.07% vs.6.84%,P =0.1721).The 1-year patient's survival rate and 1-year graft survival rate in SD group and MD group showed no significant difference (96.55% vs.98.29%,P =0.6714;94.83% vs 98.29%,P =0.2750).The serum creatinine level showed no significant differences between two groups at each visit point.There was also no significant difference in total incidence of adverse events between the two groups.In addition,there was also no statistically significant difference in the incidence of concerned and drug-related adverse events between the two groups,including infection,hemotologic abnormality,liver or renal dysfunction,gastrointestinal disorder,etc.After ATG--F administration,peripheral blood lymphocytes in the SD and the MD group immediately decreased but nearly restored to the normal level on the postoperative day 30 and 90 respectively.No severe granulocytopenia,erythropenia or thrombocytopenia occurred in both two groups.Conclusion The efficacy and safety of single high dose of ATG-F induction are non-inferior to multiple low dose ATG-F induction,moreover,single high dose of ATG-F induction is administered more conveniently and economically.
8.The application of three-dimensional simulated surgical technique in precise hepatectomy
Wenjun LIAO ; Linquan WU ; Jianghua SHAO ; Jun DENG ; Minjing ZUO ; Shubing ZOU ; Huaqun FU
Chinese Journal of Hepatobiliary Surgery 2011;17(4):292-295
ObjectiveTo study the application of three-dimensional simulated surgical technique in precise hepatectomy. MethodsFrom July 2009 to February 2010, 16 patients with primary liver cancer underwent preoperative simulated imaging and three-dimensional simulation of liver resection.The 3D extent of simulated hepatectomy and actual hepatectomy was compared and analyzed. ResultsThe shape and the extent of the liver resected were very similar in the simulated and the actual hepatectomies. The mean differences in the length, breadth and depth of the remnant livers were 0. 6118 cm,0. 4490 cm and 0. 3199 cm, respectively. ConclusionsSimulation hepatectomy could predict the extent of the actual liver resection, and provided accurate guidance and preoperative planning for precise hepatectomy.
9.Multichannel piezoelectric genesensor for the detection of human papilloma virus.
Jianghua WANG ; Weiling FU ; Minghua LIU ; Yingying WANG ; Qiang XUE ; Junfu HUANG ; Qianyong ZHU
Chinese Medical Journal 2002;115(3):439-442
OBJECTIVETo establish a method for rapid detection and sub-typing of human papilloma virus (HPV).
METHODSWe utilized the piezoelectric genosensor (PG) technique, which is a combination of the piezoelectric biosensor and gene chips for HPV identification in 22 recurrent biopsy specimens and 22 corresponding original biopsy specimens. The control samples came from normal tissue of healthy persons. A combined reaction took place on the sensor surface between the target genes and probes. The frequency of the piezoelectric sensor will decrease when such reactions occur, and the frequency decrease depends on the concentration of the target gene. Specimens were also analyzed with conventional PCR and dot blot.
RESULTSOf the 22 recurrent specimens, 15 contained HPV6 DNA, 2 HPV11 DNA, and 4 HPV16 DNA. Only one specimen was negative. All the 22 original specimens were positive: 17 harbored HPV6 DNA, 3 sequence homologous HPV11 DNA, and 2 HPV16 DNA. No HPV18 DNA was detected in any specimen. When compared with PCR and dot blot analysis, the results were essentially the same except for one specimen, which was shown to contain other sub-types of HPV.
CONCLUSIONOur results show that the piezoelectric genosensor technique is a rapid and specific method to analyze HPV.
Biosensing Techniques ; DNA, Viral ; analysis ; Humans ; Papillomaviridae ; classification ; genetics ; Papillomavirus Infections ; virology ; Polymerase Chain Reaction ; Tumor Virus Infections ; virology
10.Laparoscopic and open treatment for choledocholithiasis:a prospective clinical comparative study
Xiaochu ZHOU ; Pei XIONG ; Jianghua FU
Chinese Journal of Minimally Invasive Surgery 2001;0(06):-
Objective To compare the therapeutic results of laparoscopic and open treatment for choledocholithiasis. Methods A prospective comparison was conducted between 29 cases of laparoscopic choledocholithotomy and 35 cases of open choledocholithotomy in terms of stone removal,operative time,hospitalization day,hospitalization cost and postoperative complications. Results Stone removal was achieved in 28/29 patients by a laparoscopic approach and in 32/35 patients by a open approach( ? 2=0 71, P =0 399);average operative time was (178 3?32 4) min in laparoscopic approach and (145 8?27 1)min in open approach( t =4 27, P =0 01);the patients in laparoscopic procedures had flatus in (20 8?2 9) hour and those in open procedures did in (58 2?4 9) hours( t =37 8, P 0 05);no major complication was found in laparoscopic approach. Conclusions Laparoscopic choledocholithotomy is safe and effective and it is superier to open treatment.

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