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[媒體報導]自體纖維母細胞移植 上演現代版「畫皮」

July 13th, 2019 Posted by news 0 comments on “[媒體報導]自體纖維母細胞移植 上演現代版「畫皮」”
新聞 健康醫療百科
自體纖維母細胞移植 上演現代版「畫皮」
文/許伊婷 | 《現代保險》雜誌 | 2019.06.01 (月刊)

四年前的八仙塵爆斷送十五條生命,其餘傷者雖然倖存,卻生不如死,先是等待傷口癒合,再面臨痛苦的復健生活,留下的疤痕更是永遠的痛。衛福部統計,這場意外中,燒燙傷面積大於四十%有二四八人,其中燒燙傷面積達八十%以上共二十四人,這場粉塵煉獄燒掉不少年輕人的夢想。

而細胞治療技術將會是燒燙傷病患的新希望,透過「自體脂肪幹細胞移植」,治療創傷受損皮膚,自體重生漂亮皮膚,好比電影《X戰警金鋼狼》具有自癒能力,可迅速再生、傷口還原、延長壽命。

 

只需敷在傷口上 細胞治療竟那麼方便?

不只皮膚,人類所有器官的源頭皆來自「細胞」,而靠幹細胞去維持、修復、延長健康,甚至更健康,已經不是科幻電影才會出現的情節。臺灣整形外科醫學會秘書長戴念梓舉出「細胞治療皮膚缺損」兩大功能,一為幹細胞可分化成有用的皮膚細胞,如:表皮層的角質細胞、真皮層的纖維母細胞,並取代皮膚缺損的部分以幫助傷口癒合;二為細胞可分泌生長因子,活化傷口周邊細胞,當受傷及脆弱的細胞得到健康細胞的加持,受刺激並活化,就會有能力與健康細胞一同修復傷口。

根據衛福部去(二○一八)年九月公告的細胞治療《特管辦法》,針對大面積燒燙傷及慢性困難癒合傷口,適合的細胞治療方式為「自體脂肪幹細胞移植」;至於疤痕、皺紋、凹洞的填補修復及美觀,則適用「自體纖維母細胞移植」。

 

慢性困難癒合傷口

接受常規治療超過6周以上,仍看不出癒合程度的傷口,代表傷口細胞組織再生能力很差。可能造成的原因有:糖尿病患傷口難癒、癌症化療、免疫功能差、使用抗排斥的藥物,或是心血管疾病造成下肢動脈阻塞,血液循環不好傷口難癒……等。

兩種治療過程也不同,「自體脂肪幹細胞移植」將脂肪幹細胞顆粒做成「液態」噴灑於傷口處,或做成「膠態」塗抹於患部,並包紮至痊癒;而「自體纖維母細胞移植」,將纖維母細胞放入特殊材質培養皿上生長,細胞數量會增多到緊靠在一起,成為「細胞層片」,再經由溫度改變,讓細胞層片從培養皿上分離(細胞層片自動飄浮起來),取出後如同一片極薄皮膚,覆蓋在傷口上,同樣包紮至痊癒,還頗像聊齋誌異《畫皮》中的操作。

 

細胞治療VS.植皮

癒合快、降低復健痛苦

現行常規大面積燒燙傷會執行植皮手術,先從傷者身上取有相當厚度的皮(包括表皮層及部分真皮層),覆蓋傷口縫合或釘住前,還須先做傷口清創手術,將潰爛及血液循環不好的組織去掉,植皮才會成功,相較細胞治療僅須將細胞覆蓋在傷口上並包紮,植皮的過程較繁雜,且因為要在傷者身上別處取皮,會形成另一個傷口。

一般植皮新添的取皮傷口僅須靠敷料即可癒合,但若傷者因燒燙傷面積太大,能提供的供皮區不夠,或是因全身系統性疾病導致傷口不易癒合,那麼執行植皮手術新添的取皮傷口,就可能成為新的慢性困難癒合傷口,因此針對這類傷患,細胞治療更是迫切。

這更影響到後續的復健,因細胞治療無傷口縫合,能降低傷者復健時皮膚的拉扯感,也不會因為取皮傷口而增加疼痛,大幅降低復健的不適,也相對因此減少疤痕的增生。

 

Intraurethral co-transplantation of bone marrow mesenchymal stem cells and muscle-derived cells improves the urethral closure

September 25th, 2018 Posted by Journal Articles 0 comments on “Intraurethral co-transplantation of bone marrow mesenchymal stem cells and muscle-derived cells improves the urethral closure”

Background: Cell therapy constitutes an attractive alternative to treat stress urinary incontinence. Although promising results have been demonstrated in this field, the procedure requires further optimization. The most commonly proposed cell types for intraurethral injections are muscle derived cells (MDCs) and mesenchymal stem/stromal cell
(MSCs).

The aim of this study was to evaluate the effects of MDC-MSC co-transplantation into the urethra.


Methods: Autologous transplantation of labeled MDCs, bone marrow MSCs or co-transplantation of MDC-MSC were performed in aged multiparous female goats (= 6 in each group). The mean number of cells injected per animal was 29.6 × 106(± 4.3 × 106). PBS-injected animals constituted the control group (= 5). Each animal underwent urethral pressure profile (UPP) measurements before and after the injection procedure. The maximal urethral closure pressure (MUCP) and functional area (FA) of UPPs were calculated. The urethras were collected at the 28th or the 84th day after transplantation. The marker fluorochrome (DID) was visualized and quantified using in vivo imaging system in whole
explants. Myogenic differentiation of the graft was immunohistochemically evaluated.


Results: The grafted cells were identified in all urethras collected at day 28 regardless of injected cell type. At this time point the strongest DID-derived signal (normalized to the number of injected cells) was noted in the co-transplanted group. There was a distinct decline in signal intensity between day 28 and day 84 in all types of transplantation.
Both MSCs and MDCs contributed to striated muscle formation if transplanted directly to the external urethral sphincter. In the MSC group those events were rare. If cells were injected into the submucosal region they remained undifferentiated usually packed in clearly distinguishable depots. The mean increase in MUCP after transplantation in comparison to the pre-transplantation state in the MDC, MSC and MDC-MSC groups was 12.3% (± 11.2%, not significant (ns)), 8.2% (± 9.6%, ns) and 24.1% (± 3.1%, 
= 0.02), respectively. The mean increase in FA after transplantation in the MDC, MSC and MDC-MSC groups amounted to 17.8% (± 15.4%, ns), 15.2% (± 12.9%, ns) and 17.8% (± 2.5%, = 0.04), respectively.

Conclusions: The results suggest that MDC-MSC co-transplantation provides a greater chance of improvement in urethral closure than transplantation of each population alone.

Burdzinska et al. Stem Cell Research & Therapy (2018) 9:239
https://doi.org/10.1186/s13287-018-0990-2

Title:  Intraurethral co-transplantation of bone marrow mesenchymal stem cells and muscle-derived cells improves the urethral closure.

Authors:  Anna Burdzinska, Bartosz Dybowski, Weronika Zarychta-Wiśniewska, Agnieszka Kulesza, Marta Butrym, Radoslaw Zagozdzon, 
Agnieszka Graczyk-Jarzynka, Piotr Radziszewski, Zdzislaw Gajewski and Leszek Paczek. 

[活動消息] 瑪旺受邀參加「再生醫療臨床相關法規東區研討會」演講

August 29th, 2018 Posted by news 0 comments on “[活動消息] 瑪旺受邀參加「再生醫療臨床相關法規東區研討會」演講”

發佈日期:2018-08-29

 

在6月8日衛服部所公告的「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」(簡稱特管辦法)修正草案,將開放已證明安全且有療效的細胞治療。

有鑑於此,花蓮慈濟醫學中心於8月28日於花蓮慈濟舉辦「再生醫療臨床相關法規東區研討會」,本次研討會邀請到了衛福部醫事司 郭威中科長及各領域的醫師專家,以特管辦法開放之細胞治療主題:從細胞治療技術管理架構規劃開始到幹細胞應用於中風、整形外科、醫美等等臨床分享。

 

研討會中針對整形醫美的細胞治療,由瑪旺幹細胞醫學生物科技 陳彥聰博士針對『纖維母細胞臨床試驗申請經驗分享』進行演說。瑪旺為台灣第一個進行纖維母細胞臨床試驗的公司,並完成自體皮膚纖維母細胞於法令紋治療二期臨床試驗,目前資料已交由獨立的統計專家進行資料解盲與分析。

 

這次研討會的細胞治療臨床分享得到許多與會人員的共鳴以及熱烈討論,相信透過產官學通力合作,可以讓細胞治療得以在台灣早日落實施行,這對有需求的病人來說將是一大福音,不需跨海求援。

陳博演講20180828-再生醫療臨床相關法規東區研討會-1 20180828-再生醫療臨床相關法規東區研討會-2

[重大訊息] 瑪旺「促進毛髮生長的組合」獲准德國專利

August 6th, 2018 Posted by news 0 comments on “[重大訊息] 瑪旺「促進毛髮生長的組合」獲准德國專利”

發佈日期:2018-08-06

 

瑪旺幹細胞醫學生物科技所研發之促進生髮之成份配方,經德國專利局核准專利申請案,於7月12日核發專利證書。

 

「促進毛髮生長的組合」是利用瑪旺生技獨特培養人類皮膚間質幹細胞(SMSCs)技術,使其細胞大量分泌VEGF、HGF、KGF、TGF-β……多種生長因子製成凍乾粉末,特有毛髮生長配方,再加上能迅速穿透表皮,讓有效成份能夠深入毛囊組織,快速激活毛囊細胞,促進毛髮生長,可以改善髮質和頭髮豐厚度,可運用於落髮治療。

 

根據Persistence Market Research的預測,亞太落髮治療市場從2016到2024年,將持續維持6.6%的複合年均成長率,預測在2024年可達到2億7千萬美金的市場值;其中中國將會是落髮相關治療最大的市場,有鑑於此,瑪旺專利亦佈局於中國。

 

目前瑪旺已成功運用這項專利技術,開發生髮保養品,亦於中國CFDA進行產品進口許可證之申請,預計2019年02月取證,並進一步與中國通路合作,將有利產品於中國銷售。

[媒體報導] 製造販售PRP產品 瑪旺生技董座不起訴

July 27th, 2018 Posted by news 0 comments on “[媒體報導] 製造販售PRP產品 瑪旺生技董座不起訴”

鏡周刊報導[2018-07-26]

去年「瑪旺生技」爆發擅自將有醫材許可證的抽血用針具,放入公司自主研發的血小板血漿收集容器套組(PRP)中,作為搭配抽血時使用的器具及分裝抗凝血劑,遭調查局依違反《藥事法》移送士林地檢署。經過1年調查,士檢5日偵查終結,瑪旺生技負責人黃美月獲不起訴處分。

瑪旺生技表示,他們的血小板血漿收集容器套組能讓操作者容易取得高濃度的血小板血漿,是業界血小板濃縮倍率最高的收集容器,台北市立聯合醫院、部份榮民體系醫院及部立醫院相繼採用。

另外,為拓展國際市場,瑪旺也積極佈局日本、中國、歐盟、美國510k的相關認證,將台灣的「再生醫療」技術推向世界。

瑪旺生技強調,他們成立以來,致力於再生醫學研究,成為台灣第1個研究以皮膚為來源,純化間質幹細胞與儲存,並且設立羊膜組織庫的GTP公司,也是第1個細胞製劑完成第2期人體臨床試驗的公司,試驗結果將於本月送交主管機關解盲。

為證實由皮膚來源所培育的細胞製劑功效,瑪旺生技在八仙塵爆中,就與日本團隊合作救治傷患,以傷患的自體皮膚培養表皮細胞,成效顯著,受治療的傷患皮膚修復不會有攣縮現象,日後能正常活動。

瑪旺負責人黃美月博士素有台灣醫美教母之稱,她不但是留學德國的皮膚科醫師,還擁有30多年醫美經驗。黃美月說,皮膚間質幹細胞在全球已有越來越多的研究實證,希望她們的技術能讓台灣在全球再生醫學領域佔有一席之地。

 

新聞來源:鏡周刊-製造販售PRP產品 瑪旺生技董座不起訴

 

[重大澄清] 瑪旺PRP分離管事件風波 檢方調查終結 獲不起訴處分

July 17th, 2018 Posted by news 0 comments on “[重大澄清] 瑪旺PRP分離管事件風波 檢方調查終結 獲不起訴處分”

發佈日期:2018-07-17

2017年瑪旺生技發生將有醫材許可證的抽血用針具放入公司自主研發的血小板血漿收集容器套組(PRP)盒中,作為搭配抽血時使用的器具以及分裝抗凝血劑一案,經過士林地檢署於本月5日偵查終獲不起訴處分。

 

不起訴處份書中,檢方引述最高法院判決,若將合法藥品分裝、未以抽換、製成等方式改變藥物等成分、劑型,並不屬於藥事法第20條第1款之製造行為,因此瑪旺將購得之合法藥物溶液分裝後轉讓之行為,與藥事法所謂擅自製造藥品罪構成要件不符。

 

另一瑪旺公司所販售之“瑪旺“血小板收集容器套組(GPRP)組合包內均為取得許可證號之醫療器材,該組合包裝未依規定申請領有許可證,惟應僅屬行政規範之違反,尚難遽認被告有何擅自製造醫療器材或進而販賣之行為。

 

依刑事訴訟法第252條第10款為不起訴之處分。

Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation in Hepatitis B Virus Related Acute-on-Chronic Liver Failure Treated with Plasma Exchange and Entecavir: a 24-Month Prospective Study

May 4th, 2018 Posted by Journal Articles 0 comments on “Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation in Hepatitis B Virus Related Acute-on-Chronic Liver Failure Treated with Plasma Exchange and Entecavir: a 24-Month Prospective Study”

Background & Aim : Search for an effective therapy for patients with hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) remains an important issue. This study investigated the efficacy of umbilical cord-derived mesenchymal stem cell (UC-MSC) transplantation in patients with HBV-ACLF.

Methods : 45 consecutive entecavir-treated HBV-ACLF patients were prospectively studied. Among these patients, 11 received both plasma exchange (PE) and a single transplantation of UCMSCs (group A), while 34 received only PE (group B). The primary endpoint was survival at 24 months.

Results : Compared with group B, levels of albumin, alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, prothrombin time (PT), international normalized
ratio (INR) and model for end-stage liver disease score in group A improved significantly at 4 weeks after transplantation (p < 0.05).

Levels of albumin, PTand INR in group Awere also markedly improved at 24 months (p < 0.05). Group A had significantly higher cumulative survival rate at 24 months (54.5 % v.s. 26.5 %, p = 0.015 by log rank test). Between the two groups, levels of creatinine, White blood cell, hemoglobin and platelet were similar. HBeAg loss and hepatocellular carcinoma incidence were similar at 24 months. Group assignment (relative risk: 2.926, 95%confidence interval: 1.043– 8.203, p = 0.041) was an independent predictor for survival at 24 months. Success rate of UC-MSC transplantation was 100 % in group A. No severe adverse event was observed in any patient.

Conclusion : UC-MSC transplantation is safe and effective for HBV-ACLF patients treated with PE and entecavir. It further improves the hepatic function and survival.

Springer Science+Business Media New York 2016

Stem Cell Rev and Rep  DOI 10.1007/s12015-016-9683-3

Title:  Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation in Hepatitis B Virus Related Acute-on-Chronic Liver Failure Treated with Plasma Exchange and Entecavir: a 24-Month Prospective Study.

Authors: Yu-Hua Li & Ying Xu & Hua-Mei Wu & Jing Yang & Li-Hong Yang & Wan Yue-Meng.

Improvement of Heart Failure by Human Amniotic Mesenchymal Stromal Cell Transplantation in Rats

March 2nd, 2018 Posted by Journal Articles 0 comments on “Improvement of Heart Failure by Human Amniotic Mesenchymal Stromal Cell Transplantation in Rats”

 Background: Recently, stem cells have been considered for the treatment of heart diseases, but no marked improvement has been recorded.

This is the first study to examine the functional and histological effects of the transplantation of human amniotic mesenchymal stromal cells (hAMSCs) in rats with heart failure (HF).

  Methods: This study was conducted in the years 2014 and 2015. 35 male Wistar rats were randomly assigned into 5 equal experimental groups (7 rats each) as 1- Control 2- Heart Failure (HF) 3- Sham 4- Culture media 5- Stem Cell Transplantation (SCT).

Heart failure was induced using 170 mg/kg/d of isoproterenol subcutaneously injection in 4 consecutive days. The failure confirmed by the rat cardiac echocardiography on day 28. In SCT group, 3×106 cells in 150 µl of culture media were transplanted to the myocardium. At the end, echocardiographic and hemodynamic parameters together with histological evaluation were done.

Results: Echocardiography results showed that cardiac ejection fraction in HF group increased from 58/73 ± 9% to 81/25 ± 6/05% in SCT group (p value < 0.001). Fraction shortening in HF group was increased from 27/53 ± 8/58% into 45/55 ± 6/91% in SCT group (p value < 0.001). Furthermore, hAMSCs therapy significantly improved mean diastolic blood pressure, mean arterial pressure, left ventricular systolic pressure, rate pressure product, and left ventricular end-diastolic pressure compared to those in the HF group, with the values reaching the normal levels in the control group. A marked reduction in fibrosis tissue was also found in the SCT group (p value < 0.001) compared with the animals in the HF group.

Conclusion: The transplantation of hAMSCs in rats with heart failure not only decreased the level of fibrosis but also conferred significant improvement in heart performance in terms of echocardiographic and hemodynamic parameters.

J Teh Univ Heart Ctr 2016;11(3):123-138

The Journal of Tehran University Heart Center

Title:  Improvement of Heart Failure by Human Amniotic Mesenchymal Stromal Cell Transplantation in Rats.

Authors:  Seyed Mohammad Taghi Razavi Tousi, PhD, Mahdieh Faghihi, PhD, Maliheh Nobakht, PhD, Mohammad Molazem, DVM,
 Elham Kalantari, MSc, Amir Darbandi Azar, DVM, Nahid Aboutaleb, MD, PhD

Allogeneic Bone Marrow–Derived Mesenchymal Stromal Cells for Hepatitis B Virus–Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial

February 5th, 2018 Posted by Journal Articles 0 comments on “Allogeneic Bone Marrow–Derived Mesenchymal Stromal Cells for Hepatitis B Virus–Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial”

Mortality from hepatitis B virus (HBV)–related acute-on-chronic liver failure (ACLF) is high due to limited treatment options. Preclinical and clinical investigations have proved that treatment with mesenchymal stromal cells (MSCs) is beneficial for recovery from liver injury.

We hypothesized that the outcome of HBV-related ACLF would be improved by MSC treatment. From 2010 to 2013, 110 patients with HBV-related ACLF were enrolled in this open-label, nonblinded randomized controlled study. The control group (n 5 54) was treated with standard medical therapy (SMT) only. The experimental group (n 5 56) was infused weekly for 4 weeks with 1.0 to 10 3 105 cells/kg allogeneic bone marrow–derived MSCs and then followed for 24 weeks. The cumulated survival rate of the MSC group was 73.2% (95% confidence interval 61.6%-84.8%) versus 55.6% (95% confidence interval 42.3%-68.9%) for the SMT group (P 5 0.03). There were no infusion-related side effects, but fever was more frequent in MSC compared to SMT patients during weeks 5-24 of follow-up. No carcinoma occurred in any trial patient in either group. Compared with the control group, allogeneic bone marrow–derived MSC treatment markedly improved clinical laboratory measurements, including serum total bilirubin and Model for End-Stage Liver Disease scores. The incidence of severe infection in the MSC group was much lower than that in the SMT group (16.1% versus 33.3%, P 5 0.04).

Mortality from multiple organ failure and severe infection was higher in the SMT group than in the MSC group (37.0% versus 17.9%, P 5 0.02). Conclusion: Peripheral infusion of allogeneic bone marrow–derived MSCs is safe and convenient for patients with HBV-related ACLF and significantly increases the 24-week survival rate by improving liver function and decreasing the incidence of severe infections.

Copyright © 2017 by the American Association for the Study of Liver Diseases.
View this article online at wileyonlinelibrary.com.  DOI 10.1002/hep.29189

HEPATOLOGY, VOL. 66, NO. 1, 2017

Title:  Allogeneic Bone Marrow–Derived Mesenchymal Stromal Cells for Hepatitis B Virus–Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial.

Authors:  Bing-liang Lin, Jun-feng Chen, Wei-hong Qiu, Ke-wei Wang, Dong-ying Xie, Xiao-yong Chen, Qiu-li Liu, Liang Peng, Jian-guo Li,
Yong-yu Mei, Wei-zhen Weng, Yan-wen Peng, Hui-juan Cao, Jun-qiang Xie, Shi-bin Xie, Andy Peng Xiang, and Zhi-liang Gao1, 
Andy Peng Xiang, and Zhi-liang Gao

Clinical and laboratory evaluation of patients with end-stage liver cell failure injected with bone marrow-derived hepatocyte-like cells

January 29th, 2018 Posted by Journal Articles 0 comments on “Clinical and laboratory evaluation of patients with end-stage liver cell failure injected with bone marrow-derived hepatocyte-like cells”

    Aim: One of the defining features of the liver is the capacity to maintain a constant size despite injury. Extrahepatic stem cells especially bone marrow-derived stem cells are thought to undertake an important role in liver repopulation. This study was carried out to evaluate the outcome of autologous bone marrow-derived hepatocytes transplantation in patients with end-stage liver cell failure due to chronic hepatitis C.

Methods: Forty patients were included, divided into two groups. Group I: 20 patients receiving autologous bone marrow-derived mesenchymal stem cells stimulated to hepatic lineage. They were subdivided into two groups regarding the route of transplantation: intrasplenic (10) and intrahepatic (10). Group II: included 20 patients who received traditional supportive treatment. Patients were followed up using examination, laboratory investigations, abdominal ultrasonography, and evaluated by Child score, Model for End Stage Liver Disease score, fatigue scale, and performance status.

  Results: The results showed significant improvement in group I regarding ascites, lower limb edema, and serum albumin, over the control group. Group I also showed  statistically significant improvement in Child score, Model for End Stage Liver Disease score, fatigue scale, and performance status over the controls. No difference was observed between intrahepatic and intrasplenic groups.

  Conclusion: This study demonstrated the safety and short-term efficacy of autologous bone marrow-derived mesenchymal stem cell injection in liver cell failure. Further study is necessary to standardize the cell dose, determine the life span of the injected cells, and detect the appearance of long-term complications.
Gastroenterol Hepatol 23:936–941

©2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

European Journal of Gastroenterology & Hepatology 2011, 23:936–941

DOI: 10.1097/MEG.0b013e3283488b00

Title:  Clinical and laboratory evaluation of patients with end-stage liver cell failure injected with bone marrow-derived hepatocyte-like cells.

Authors:  Mohie-Eldeen M. Amer, Samy Z. El-Sayed, Wael Abou El-Kheir, Hala Gabr, Ahmed A. Gomaa, Nabil El-Noomani and Mohamed Hegazy.