Cordlife Educational Booklet - Cord Blood

parents need toknow about cord

blood banking

迎接上天恩賜的無價寶，

How will you welcome the arrival of nature’s most precious gift?

臍血儲存篇101 things

您準備什麼厚禮回報？

Are You Ready?

Dear Expectant Parent,

You may already know that your baby’s cord blood is a source of hope; with rich Haematopoiectic stem cells (HSCs) that may one day save the lives of your loved ones. HSCs are the basis of bone marrow transplants, a technique used to treat diseases such as leukaemia for many decades. These cells have proven use in the treatment of an increasing number of diseases today, and continuing breakthroughs show great promise to revolutionise cellular therapy and regenerative medicine in the near future.

We understand that stem cell banking is a personal decision that should be made with a full understanding of the current and potential lifesaving possibilities. In the following pages we have put together accurate and evidence-based information on cord blood stem cells. We hope this will help you make an informed decision on this once-in-a-lifetime opportunity.

Just like the parent and child bond, we at Cordlife, are with you for the long haul. Having been entrusted by tens of thousands of families in Asia, we are confident that we have the right expertise and experience to help you take care of you baby’s stem cells. At the end of the day, we are here to give hope and save lives.

We look forward to you joining the Cordlife Community.

Congratulations! This must be an exciting time for you as you await the arrival of your baby. With your pregnancy coming to a close, I am glad that you consider stem cell banking as one of the essential preparations for your child.

Cordlife (Hong Kong) Limited

您，準備好了嗎 ?

恭喜您 ! 正在期待小寶寶出生的您，心情一定十分興奮。臨盤在即，為寶寶一生作一個最佳準備── 保留臍血幹細胞，是您最明智的決定。

康盛人生 (香港 ) 有限公司

也許您已經知道臍血的重要性。這蘊含豐富造血幹細胞 (HSCs) 的希望之源，將來可能會成為您孩子的救命匙。近數十年，醫學界都以骨髓移植作為治療白血病等危疾的主要方法，而骨髓移植的關鍵就在於造血幹細胞的移植。時至今日，醫學界已證實造血幹細胞能應用於越來越多的疾病，有關研究更不斷出現突破，相信在不久將來，一定會為細胞治療和再生醫學方面帶來新貢獻。

儲存臍血是一項關乎您孩子和家人將來的決定。我們明白您一定想知更多有關方面的最新資訊，所以特意為您準備這份小冊子，裡面詳列一切有關臍血幹細胞的正確資料，並提供相關醫學證據作參考，相信定能令您安心抉擇，把握這個一生只有一次的寶貴機會。

孩子和父母的聯繫不可分割，康盛人生也將與您並肩前行。我們的服務專業完備，在亞洲各地深受數以萬計的家庭信賴。我們具備卓越的人才和豐富的經驗，定能為您寶寶妥善儲存幹細胞，在有需要時給予希望，挽救生命。

熱切期待您加入康盛人生的大家庭。

致各準父母：

What is Cord Blood? 什麼是臍血?

Why Bank Cord Blood? 為何要儲存臍血?

Diseases Treated with Stem Cells and its Potential Applications 幹細胞可治療的疾病和其潛在的應用

Cordlife’s Successful Cases 康盛人生的成功案例

Cord Blood ── Collection, Processing and Cryopreservation 臍血──收集、處理及低溫儲存須知

5 Simples Steps To Bank With Cordlife 選用康盛人生，只需5個簡單步驟

1

2

4

8

10

18

Contents目　錄

1

What is cord blood?什麼是臍血 ?

What are cord blood stem cells?什麼是臍血幹細胞 ?

Cord blood, also called “placental blood”, is blood that remains in the umbilical cord and placenta following the birth of a baby and after the umbilical cord is cut. During pregnancy, the umbilical cord functions as a lifeline between mother and child. After a baby’s delivery, the cord blood present in the umbilical cord could offer hope for the child or members of the family.

臍血，又稱「胎盤血」，是產婦於生產時臍帶被剪後遺留於臍帶和胎盤中的血液。懷孕期間，臍帶是嬰兒和母親的重要命脈。出生之後，臍血一樣重要，因它將會為孩子和家人在必要時帶來希望。

Cord blood is a rich source of haematopoietic stem cells (HSCs), which are primarily responsible for replenishing blood and regenerating the immune system. They have the unique ability to differentiate into various cell types found in blood as depicted in the diagram below:

臍血含有非常豐富的造血幹細胞 (HSCs)。造血幹細胞除了能補充血液和促進免疫系統再生之外，更賦予獨特能力分化成不同種類的血細胞，包括 :

Blood and immune cells:血液和免疫系統細胞 :

Function:功能 :

Carry oxygen to all cells in the body

運載氧氣送往全身

Assist blood clotting in the event of injury

身體受傷時幫助凝血Fight infection

抵抗感染

Red blood cells紅血球

White blood cells白血球

Platelets血小板

What什麼是臍血 ?

Is Cord Blood?

2

Source來源

Bone Marrow骨髓

Peripheral Blood周邊血

Cord Blood臍血

Collection採集

Multiple extractions from donor invasive operation under general anaesthesia

先替捐贈者進行全身麻醉，再進行入侵性手術重複抽取

Donor needs to be injected multiple times with growth factor to induce

the release of HSCs into blood stream捐贈者須接受多次生長因子注射刺激身體釋放造血幹細胞至血流

At the time of delivery. Quick, painless and risk-free for both mother and child

於生產時採集，安全快捷，對母體和嬰兒均無痛無害

Availability供應

Requires extensive donor search須尋找合適捐贈者

Requires extensive donor search須尋找合適捐贈者

Readily available when needed需要時即可使用

Quality of Stem Cells幹細胞質素

Older and less primitive較老且原始性較低

Older and less primitive較老且原始性較低

Younger and more primitive年輕且較原始

Graft vs. Host Disease排斥反應

Higher incidence較高發生率

Higher incidence較高發生率

Lower incidence較低發生率

Matching Tissues脗合組織

Requires a perfect match between donor and recipient

須尋找完全脗合的損贈者和受贈者

Requires a perfect match between donor and recipient

須尋找完全脗合的損贈者和受贈者

Does not requires a perfect match between donor and recipient

無須尋找完全脗合的損贈者和受贈者

Retrieval Cost提取費用

Can cost as high as US$25,000可高達 25,000 美元

Can cost as high as US$10,000可高達 10,000 美元

100% ownership with no extra retrieval cost for private banking私人儲存，100% 擁有權，無額外儲存費用

Why為何要儲存臍血 ?

Bank Cord Blood?

Although cord blood stem cells can also be found in bone marrow and peripheral blood (blood that circulates through your body), stem cells from cord blood are being increasingly used as a preferred source of adult stem cells in transplant medicine. The table below illustrates the clear advantages cord blood has over other sources of stem cells.

雖然人體的骨髓和周邊血 ( 運行全身的血液 ) 都擁有幹細胞，不過越來越多成體幹細胞移植選擇採用臍血幹細胞。臍血幹細胞為什麼比其他來源的幹細胞優秀 ?

Advantages of cord blood stem cells臍血幹細胞的優點

Who can use my baby’s cord blood?誰可使用我寶寶的臍血 ?

Likelihood of locating a matching cord blood unit compared to bone marrow.

與骨髓相比，找到配型脗合的臍血機會

The stem cells from the cord blood you stored will be a perfect match for your baby. It is also a ready source of genetically related stem cells for someone else in the family. Compared to bone marrow or other sources of stem cells, the likelihood* of locating a matching cord blood unit is 60% higher for siblings.

您儲存的臍血幹細胞與您寶寶的配型是完美脗合的。它也是為其他家庭成員準備的一個有基因聯繫的現成幹細胞來源。在兄弟姐妹間找到配型脗合的臍血幹細胞的機會 *，比骨髓幹細胞或者其他來源的幹細胞高出 60%。

*Sources / 資料來源：Beatty PG, Boucher KM, Mori M, et. al. Human Immunology. 2000;61;834-840.

Perfect match for self.

60%

100% 自體完全脗合

3

Why為何要儲存臍血 ?

Bank Cord Blood?

A General Overview: How are stem cells used?概要：幹細胞有什麼用途 ?

Stem cell transplantation幹細胞移植

This is done to rebuild a patient’s blood and immune system, following treatment such as chemotherapy, which destroys blood cells. The HSCs are infused directly into the patient’s blood stream, which hopefully will migrate to the bone marrow. Inside the bone marrow, the HSCs begin to differentiate into blood and immune cells w h i c h w i l l i n d u c e t h e regeneration of the blood and immune system.

移植幹細胞的主要目的是重建病人因接受化療而受損的血液和免疫系統。造血幹細胞會直接注入血管，再輸送到骨髓。在骨髓中幹細胞會分化為血細胞和免疫細胞，刺激血液及免疫系統的再生。

Cellular therapy is about using stem cells as an alternative natural source to treat

diseases. Regenerative medicine is about repairing damaged tissue or organs. Both these methods are being actively researched in many clinical trials.

In studies for indications such as spinal cord injury and heart attack, stem cells have been directly injected into the damaged tissue. Some of the benef i ts experienced appear to be due to new blood

vessel formation, which restores blood flow to the damaged tissue.

To date, the majority of these therapies require the patient’s own

stem cells, not those from a donor.

細胞治療是指利用幹細胞作為另一種的天然資源治療疾病。而再生醫學的目的是為了修

復受損組織或器官。醫學界已致力透過許多臨床測試研究這兩種醫療方法。

在治療某些疾病，例如脊椎損傷和心臟病的時候，幹細胞會被直接注入受傷組織。部份病人的傷患部份於接受移植後生出新血管，重建受傷組織的血液供應。目前大部份此類技術需用病人自體幹細胞，不能接受損贈的幹細胞。

Cellular therapy and regenerative medicine細胞治療及再生醫學

4

血液癌症‧急性骨髓性白血病*‧急性淋巴母細胞白血病*‧慢性骨髓性白血病*‧組織細胞腫瘤‧其他骨髓增生性腫瘤‧骨髓發育異常綜合症*‧多發性骨髓瘤

實體瘤‧何杰金氏淋巴瘤*‧非何杰金氏淋巴瘤*‧郎格罕組織細胞增生症*‧神經母細胞瘤*‧視網膜母細胞瘤

非惡性血液疾病‧再生障礙性貧血*‧切 - 東二氏綜合症*‧先天性紅細胞生長不良性貧血‧戴 - 布二氏綜合症*‧迪格奥爾格綜合症*‧伊文思症侯群*‧范康尼貧血*‧格蘭兹曼氏血小板機能不全*‧白細胞黏力缺失症*‧陣發性夜間血紅蛋白尿‧單純紅細胞再生障礙‧鐮狀細胞貧血*‧重型地中海貧血*‧遺傳性骨髓衰竭綜合症*

免疫缺陷疾病‧慢性肉芽腫病*‧普通可變異免疫缺陷*‧嚴重複合型免疫缺陷*‧維 - 奥二氏症候群*

代謝紊亂疾病‧腎上腺腦白質營養不良症*‧戈謝病 - 葡萄糖腦苷脂儲積症‧赫爾勒綜合症*‧克拉伯病*‧異染性腦白質營養不良*‧骨硬化病*‧沃爾曼氏症*

以上是一些使用臍血、骨髓和周邊血的造血幹細胞治療的疾

病。幹細胞療法將繼續不斷變化和迅速發展。儲存臍血並不保

證這些細胞可於任何情況下適用或治癒疾病。是否使用將由主

診醫生作最終決定。

*以臍血幹細胞治療

Blood Cancers•Acute Myelogenous Leukaemia*•Acute Lymphoblastic Leukaemia*•Chronic Myelogenous Leukaemia*•Histiocytic Neoplasms•Other Myeloproliferative Neoplasms•Myelodysplastic syndrome*•Multiple Myeloma

Solid Tumors•Hodgkin Lymphoma*•Non-Hodgkin Lymphoma*•Langerhans’ Cell Histiocytosis*•Neuroblastoma*•Retinoblastoma

Non-Malignant Blood Disorders•Aplastic Anaemia*•Chediak-Higashi Syndrome*•Congenital Dyserythropoietic Anaemia•Diamond-Blackfan Syndrome*•DiGeorge Syndrome*•Evans Syndrome*•Fanconi’s Anaemia*•Glanzmann's Thrombasthenia*•Leukocyte Adhesion Deficiency*•Paroxysmal Nocturnal Hemoglobinuria•Pure Red Cell Aplasia•Sickle Cell Anaemia*•Thalassemia Major*•Hereditary BM failure syndromes*

Immunodeficiency Disorders•Chronic Granulomatous Disease*•Common Variable Immunodeficiency*•Severe Combined Immune Deficiency (SCID)•Wiskott-Aldrich Syndrome*

Metabolic Disorders•Adrenoleukodystrophy*•Gaucher’s Disease•Hurler Syndrome*•Krabbe Disease*•Metachromatic leukodystrophy*•Osteopetrosis*•Wolman Disease*

The above is a list of some of the diseases that have been treated with cord blood and other sources of similar type of stem cells (Haematopoietic stem cells), like bone marrow and peripheral blood. Stem cell therapies continue to change and evolve quickly. Banking cord blood does not guarantee that the cells will provide a cure or be applicable in every situation. Use will be ultimately determined by the treating physician.

*Treated with cord blood stem cells

Diseases幹細胞可治療的疾病

Treated With Stem Cells

5

Potential幹細胞潛在的應用

Applications Of Stem Cells

Clinical Trials臨床試驗

With the advancement of stem cell# research, the potential for future use of stem cell grows.Below is a list of diseases currently under Clinical Trials. These are diseases for which stem cell treatments have shown to be beneficial, but have yet to be implemented as a standard treatment. Some of these stem cell transplants only slow down the progression of the diseases, but do not produce a cure. For other diseases, the stem cell treatments may result a cure, but the optimum dosage and usage of the stem cells is still under study.For the latest information, please visit www.clinicaltrials.gov

隨著幹細胞# 科研進步，幹細胞未來使用的潛力亦不斷增長。以下的疾病處於臨床試驗階段，幹細胞治療證實對這些疾病有幫助，但還未被採用為標準的治療方案。有些幹細胞移植只能減慢疾病惡化的速度，但不可以治癒。至於其他疾病，幹細胞治療可能成為治癒方法，但幹細胞的最佳劑量和用法仍在研究中。

有關最新資訊，請瀏覽 www.clinicaltrials.gov

‧軟骨修復

‧腦痲痺*

‧腸道克隆病

‧一型糖尿病*

‧尤因肉瘤

‧多發性硬化症

‧心肌梗塞

‧風濕性關節炎

‧脊髓損傷*

• Cartilage repair

• Cerebral palsy*

• Crohn’s disease

• Diabetes Type 1*

• Ewing Sarcoma

• Multiple Sclerosis

• Myocardial Infarction

• Rheumatoid Arthritis

• Spinal cord injury*

# Stem cells mentioned here comprise of other cell lines such as Mesenchymal stem cells & etc. The clinical trials and experimental treatments listed above may be using other lines of stem cells, and not only Haematopoietic stem cells.

*Treated with cord blood stem cells

#這裡提及的幹細胞包括間質幹細胞和其他的幹細胞。以上列出的臨床測試和試驗性治療，不只使用造血幹細

胞，亦可能包括其他幹細胞作治療。

*以臍血幹細胞治療

6

7

Note: Treatment of some types of Leukaemia and blood cancers will not use the child’s own stem cells, but stem cells have been used in sibling transplants in such cases. The decision as to whether the child’s own stem cells can be used, is one made by the highly experienced transplant physician.

註：治療某些白血病及其他血癌的個案並不會採用小童自體的幹細胞，而採用兄弟姐妹的幹細胞作移植，至於是否採用小童自體幹細胞作移植則由富經驗的移植醫生決定。

Top 5 reasons why you should consider banking cord blood儲存臍血的 5 大原因

Applications造血幹細胞之應用

Of Haematopoietic Stem Cells (HSCs)

1 in 217 individuals1 may need a haematopoietic stem cells (HSCs) transplant by the age of 70, according to a scientific paper published in 2008.

根據2008年發表的一份文獻指出，每217人當中，便有1人於70歲前需要接受造血幹細胞移植1。

Research showed that patients have a lower chance of complications in transplants when they receive stem cells from a relative3.

研究結果顯示，接受近親幹細胞移植的病人出現移植併發症的機會較低3。

It is once-in-a-life time chance to collect cord blood – a readily available source when needed in the future.

一生只有一次收集臍血的機會-有需要時可即時使用。

60% higher chance2 of locating a matching cord blood unit in the family compared to bone marrow.

於同一個家庭中，找到脗合的臍血造血幹細胞機會相比骨髓高出60%2。

Some of the most common cancers are treatable with stem cell transplant. For instance, Non-Hodgkin’s Lymphoma is one of the top 10 common cancers in Hong Kong4; whereas Leukaemia and Lymphoma are 2 of the top 5 most common childhood cancers5 in Hong Kong.

某些常見癌症可通過幹細胞移植治癒，例如：香港十大常見癌症之一的非何杰金氏淋巴瘤4，以及香港五大兒童癌症的其中兩種 – 白血病(血癌)和淋巴癌5

Sources / 資料來源 : 1. Nietfeld JJ, Pasquini MC, Logan BR, Verter F, Horowitz MM. Lifetime probabilities of hematopoietic stem cell transplantation in the U.S. Biology of Blood and Marrow Transplantation. 2008;14:316-322.

2. Beatty PG, Boucher KM, Mori M, et. al. Human Immunology. 2000;61;834-840. 3. Wagner JE, Steinbuch M, Kernan NA, et. al. The Lancet. 1995;346;214-219 Kurtzberg J, Laughin M, Graham ML, et. al.

New England Journal of Medicine. 1996;335;157-66. 4. Leading Cancer Sites in Hong Kong. Hong Kong Cancer Registry Website. http://www3.ha.org.hk/cancereg/e_rank.pdf.

Accessed 13 July 2011. 5. Cancer in Children and Adolescents (0-19 years). Hong Kong Cancer Registry Website. http://www3.ha.org.hk/cancereg/

e_child.pdf. Accessed 13 July 2011

8

Successful Cases康盛人生的成功案例Cordlife’s

Transplant with cord blood stem cells:臍血幹細胞移植：

Neuroblastoma boy treated by his own cord blood自體移植協助治療神經母細胞瘤

Justin (alias) was diagnosed with a common childhood cancer, neuroblastoma, at a tender age of one and half years old. Over the course of 1 year, the child had to endure numerous rounds of high-dose chemotherapy to treat his condition. Chemotherapy destroys cancer cells, but at the same time also kills normal cells. Fortunately, Justin's parents had his cord blood stored at birth with Cordlife. To improve his chance of survival and replace the normal cells being destroyed,

Justin's cord blood stem cells were infused back to his body after a course of chemotherapy in January 2011 at Queen Mary Hospital. This fi rst-of-its-kind procedure in Hong Kong is often used worldwide to treat patients with similar conditions.

Justin（化名）於 1 歲半時證實患上幼兒期常見的惡性腫瘤──神經母細胞瘤。在過去 1 年的療程中，Justin 經歷多次高劑量的化療控制病情。化療雖可以破壞癌細胞，亦同時殺死正常細胞。可幸是 Justin的父母於 Justin 出生時為他於康盛人生儲存了臍血。經一輪的化療後，2011 年 1 月 Justin 接受自體臍血移植以提高生存機會及補充被破壞的正常細胞。這一連串的治療於香港瑪麗醫院進行，跟世界各地醫院治療類似情況患者的程序無異。

Related transplant to treat leukaemia近親移植協助治療白血病

Little Ryan was suffering from leukarmia at a tender age of three. Despite a nation-wide search for bone marrow stem cells, a suitable donor could not be found. Fortunately, baby sister of Ryan,Rachel was born during that critical period which enabled the family to store Rachel’scord blood with Cordlife, for Ryan’s transplant. Now 12, Ryan is in school and his leukaemia isin remission.

“We were elated when Rachel’s blood was shown to be a 100% match for Ryan. The healthy cells from his sister re-populated in his bone marrow and revived his immune system,” said Dr Tan Ah Moy, Head and Senior Consultant for Haematology and Oncology Services at the KK Women’s and Children’s Hospital where the transplant was performed.

小小 Ryan 在 3 歲時已證實患上白血病。雖然已在全國搜尋合適骨髓，惜遍尋不獲。幸好這時，Ryan 的妹妹── Rachel 出世了。Ryan 父母馬上找康盛人生替 Rachel 保留臍血為 Ryan 作移植。現在 Ryan 12 歲了，可以如常上學，白血病亦已完全痊癒。

負責移植手術的新加坡竹腳婦幼醫院血液及腫瘤科主管及高級顧問醫生 Dr Tan Ah Moy 表示：「很高興Rachel 的臍血跟 Ryan100% 脗合。妹妹健康的細胞移植到 Ryan 的骨髓後，成功幫助 Ryan 建立自己的免疫系統。」

9

Successful Cases康盛人生的成功案例Cordlife’s

Cellular Therapy:細胞治療：

An accident at birth in 2007 deprived Baby Georgia of oxygen to her brain, resulted in cerebral palsy. The damage to the toddler’s brain caused her to move involuntarily, suffer from muscle spasms and have up to 50 seizures a day. It was only after Cordlife put the family in touch with a renowned neurosurgeon that enabled Georgia to be infused with her own cord blood, also stored by Cordlife. Her conditions has improved since then.

“Georgia has made good progress since her stem cell infusion. She has better visual focus and eye contact with adults during play. She has more vocalization and tries to “sing-a-long’ by making different sounds to nursery rhymes. Georgia has improved postural and head control and is observed to be reaching more with her arms,” said Ms.Jaclyn Tan, Consultant Therapist at OzWorks Therapy.

2007 年，因為出生時出現意外，令小小 Georgia 腦部缺氧導致腦痲痺。腦部損傷令她不自主活動，出現肌肉痙攣，病發次數多達每天 50 次。幸好 Georgia 的父母早為孩子在康盛人生儲存了臍血。康盛人生為 Georgia 找到一位知名的腦科醫生並順利進行移植。現在 Georgia 情況已日漸好轉。

OzWorks Therapy 職業治療師 Jaclyn Tan 表示：「Georgia在接受幹細胞移植後的康復情況十分理想。現在跟大人玩遊戲的時候視力更能集中，有更多的眼神交流；發聲表現有進步，會嘗試跟著兒歌發出不同音調；在控制身體和頭部活動方面亦較之前理想。在觀察期間，Georgia 比以前更多嘗試伸力取物。」

Source: The Sun, 3 December 2009資料來源：太陽報 2009 年 12 月 3 日

10

Collection, Processing And Cryopreservation臍血 ─ 收集、處理及低溫儲存須知Cord Blood ─

How is cord blood collected? 如何收集臍血?

How much cord blood can be collected from my baby’s umbilical cord?在我寶寶的臍帶中可收集多少臍血?

Other than cord blood, what else will you collect?除了臍血，還要收集什麼?

The collection of cord blood is a painless, safe and quick process which does not interfere with the birthing process. Cord blood has to be collected at the time of delivery by the obstetrician or caregiver. After the baby is born, the umbilical cord will be clamped and within minutes, the obstetrician or caregiver will drain the cord blood into a sterile double-wrapped single-use blood bag. Your Cordlife Cord Blood Collection Kit contains all the necessary materials to complete the collection of cord blood.

Of course, the collection of cord blood is secondary to any medical issues that may arise during the birth and the decision to collect will always reside at the sole discretion of the obstetrician or caregiver.

臍血收集過程快速，對母嬰均無痛無害，更不會影響分娩程序。臍血會於分娩時由醫護人員收集。嬰兒出生後，醫生會馬上結紮臍帶，然後把臍血注入雙層一次性即棄血袋。康盛人生所提供的「臍愛盒」會配備一切所需工具收集臍血。

當然，母嬰情況最重要。醫護人員會根據媽媽和寶寶於分娩時的健康狀況決定應否收集臍血。

The quantity of cord blood collected varies from baby to baby. On an average, about 60-75ml of cord blood can be collected from an Asian baby. However, the important factor is not the volume of blood collected but the number of nucleated cells harvested after processing. We encourage obstetricians and caregivers to collect as much cord blood as possible and we will process even small amounts. It should be noted that scientists around the world have achieved progress in double cord blood transplants and stem cell expansion. Therefore, even cord blood units with low cell counts may be useful in the future.

每個寶寶的臍血收集量都不同。一般從亞洲嬰兒的臍帶中可抽取 60 至 75 毫升的臍血。不過抽取量多少並不重要，最重要的是處理臍血後能採集多少有核細胞。我們建議接生的醫護人員盡量多抽取臍血。縱使收集量少，我們亦會繼續處理，因為世界各地的科學家在雙份臍血移植和幹細胞增容方面的研究都有很大進展，所以即使臍血中只含少量幹細胞，將來可能也很有用。

Samples of maternal blood also need to be drawn within 48 hours prior or after your baby’s delivery. The maternal blood will be tested for a battery of infectious diseases, including HIV, Hepatitis B and C, Cytomegalovirus, Syphillis and HTLV. These tests are the basic requirement in determining the safety and quality of the collected cord blood for future use. It will be conducted by our appointed HOKLAS and CAP accredited facility in Hong Kong.

在分娩前或後 48 小時內需抽取孕婦血液樣本，測試是否受傳染性疾病感染，包括愛滋病、乙型及丙型肝炎、巨細胞病毒、梅毒和 T- 淋巴細胞病毒 (HTLV)。必須通過這幾項化驗，才能確保已收集的臍血的質素及安全作日後使用。血液樣本會交由康盛人生指定，並獲得香港實驗室認可計劃 (HOKLAS) 及美國臨床病理醫學會 (CAP) 會員認證的實驗室化驗，值得信賴。

11


What technology does your company use for processing?康盛人生的臍血處理技術

What does cord blood processing entail?如何處理臍血?Other than stem cells, cord blood contains red blood cells, white blood cells and plasma. The objective of cord blood processing is to extract as much stem cells as possible for final cryopreservation. The amount of stem cells that can be harvested from cord blood is dependent on the harvesting technology chosen.

除了幹細胞以外，臍血中還含有紅血球﹑白血球和血漿。抽取臍血的目的，是要從中盡量抽取有用的幹細胞作低溫冷藏，由於幹細胞採集數量多寡直接受採集方法影響，所以必須小心選擇。

Cordlife is the only private cord blood bank in Hong Kong that utilises Sepax®2 for cord blood processing. Recently, Hong Kong public cord blood bank has also chosen Sepax® over other automated cord blood processing systems which reaffirmed the technical superiority of the system. Your baby's cord blood could turn out to be the most precious gift to your child, that's why we have powered up the cord blood processing technology. Sepax®2, precision technology made in Switzerland, recognized by international accreditations, safe and reliable, achieve the reproducible high results.

Cord blooding processing automation brings demonstrable advantages, such as an optimal stem cell recovery and impeccable sterility and traceability of the product. Naturally, there are also fewer errors caused by operator intervention. In fact, Sepax®2 is the only cord blood closed processing technology that takes care of one single cord blood unit at a time, which further ensures full traceability and eliminates the risk of accidental mix-up with other units.

康盛人生是本港唯一配備 Sepax®2 的私營臍血庫。繼康盛人生率先於香港引進 Sepax® 後，香港公營臍血庫亦相繼於芸芸臍血處理系統中挑選 Sepax®，再次肯定 Sepax® 技術的優勢。因為您寶寶的臍血有可能成為拯救生命的資源，所以我們全面提升原有的全自動化臍血處理系統。Sepax®2 由瑞士精密技術製造，榮獲多項國際驗證，保證安全可靠，令臍血處理達到最佳效果。

臍血處理自動化帶來明顯優勢，包括最佳幹細胞採集量，絕對的產品無箘性及可追溯性。正因為全自動化處理，免除了操作人員介入而引致的人為錯誤。Sepax®2 亦是唯一每次獨立處理一份臍血的密閉式處理系統，確保樣本可被追溯之餘，更能杜絕樣本意外混淆。

Sepax® 2World’s only fully automated stem cell processing systemIndustry Gold Standard Automation System全球唯一全自動化臍血處理系統業內發展新領域


Sepax®2 Automated Stem Cell Processing SytemSepax®2 全自動化臍血處理系統

Sepax® series has been worked for over 14 years since 1999Sepax® 處理系統系列已運作超過 14 年（自 1999 年起）

Able to achieve a Total Nucleated Cell (TNC) recovery rate as high as 採集總有核細胞量 (TNC)99.46%2

Every cord blood unit processed individually; no other external centrifuge or operator intervention is required during the procedure.每次獨立處理一份臍血，過程中無須依賴額外的離心機或人手操控。

All parts made in Europe, assembled and sterilized in Switzerland or Italy.所有組件於歐洲製造，瑞士或意大利裝嵌及作最後消毒程序。

Never.沒有。

Yes.有。

Sources / 資料來源：1. Sepax benefits at a glance. Biosafe. Accessed on 28 June 2011. (www,biosafe.ch/en.international/For+future+parents/Sepax+benefits.html)2. Cordlife validations studies.

12

Years of Experience經驗

International Application國際應用

Stem Cell Recovery Rate幹細胞採集量

Processing Procedure處理過程

Origin of Processing Kit處理組件生產地

Product Recall產品回收問題

Is processing kit tested by the system automatically each time before cord

blood processing? (Critical step)每次處理臍血前自動測試處理組件?

(十分重要的程序)

Sepax® processed more than 450,000 stem cell units in over 40 countries, of which more than 2,000 cord blood units have been used in transplantation; official collaborator of NetCord organization, used by 70% of NetCord cord blood banks in Europe and over 50% of cord blood banks funded by Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS)1.

Sepax® 於 40 多個國家處理超過 450,000 份幹細胞。其中超過 2,000 份臍血樣本已被成功移植；NetCord 組織官方合作伙伴，超過 70%NetCord在歐洲的臍血庫及超過 50% 由美國衞生褔利部 (HHS) 的行政機構衞生資源與服務管理局 (HRSA) 資助 1 的臍血庫使用

13


How do you store cord blood stem cells?如何儲存臍血幹細胞

When it comes to cord blood banking, we always insist on the best so that our clients can have better transplant and cellular therapy outcome. The cryogenic storage tanks used by Cordlife, MVE Anti-contamination Vapour-phase Liquid Nitrogen Storage System, have been used and trusted by the majority of private cord blood banks in the world for decades. Unlike other storage systems available in the market today, our tanks have never been recalled by the U.S. FDA or the manufacturer.

我們致力提供最優質的臍血儲存服務，確保客戶能獲得最佳的移植和細胞治療效果。康盛人生選用的低溫儲存缸 ── MVE抗感染氣態氮儲存系統，深得全球絕大部分私營臍血庫採用及信賴，數十年來信譽超著。我們的儲存缸，從未被美國食品及藥物管理局或廠商要求回收，非現今業內其他儲存系統可媲美。

Always insist on the best恪守宗旨，提供最優質服務

Design for optimum performance專業設計，力臻完美

Cord blood stem cells remain at cryopreservation condition as long as they are stored below Glass Transition Temperature (-135˚C). MVE system is designed to feature precise temperature control at -190˚C, far below the critical point of temperature.臍血只要儲存於玻璃轉化溫度攝氏零下135度以下，幹細胞便可維持低溫冷藏狀態不變。 MVE儲存缸設計精密，能保持儲存溫度於攝氏零下190度，遠低於臨界溫度。

Equipped with a monitoring system that scans for any out-of-range conditions to ensure the temperature is maintained at optimum range.系統配備監察裝置，時刻監控，確保儲存溫度維持在最佳範圍以內。

A liquid nitrogen reservoir is present below the sample platform. This will typically maintain the desired temperature for the samples in the storage tank for more than 20 days due to vapor created by the liquid nitrogen.樣本平台下設有液態氮儲備器，產生的氣態氮可維持樣本低溫超過20天。

•

•

•

14


Comparison between different cord blood storage systems臍血儲存系統比較表

Sources / 資料來源：1. Saritha KR, Bongso A. 2001. Journal of Andrology. 22(5):857-862.2. International Society for Biological and Environmental Repositories. 2005. Cell Preservation Technology. 3(1):5-48.

• Recent reports indicate that infectious organisms such as hepatitis B viruses have shown to survive in liquid nitrogen1, validating the risk of cross-contamination for cord blood units stored in liquid phase of the nitrogen tank.

報告顯示具傳染性的生物如乙型肝炎病毒可於液態氮中生存 1，對液態氮儲存糟內的臍血樣本構成交叉感染風險。

• Documented diseases transfer via contaminated liquid nitrogen2.

文獻記載受污染的液態氮儲存糟曾傳播病毒 2。

• Majority of public cord blood banks use liquid freezers. Client accountability is insignificant.

大部份的公營臍血庫則採用液態氮儲存糟。

• Liquid freezer’s closed design does not allow monitoring inside the freezer.

液態氮儲存糟密閉式的設計，不能透視糟內是否如常運作。

• Relies on the power to operate and is controlled by computer. 需依靠電力運作和電腦控制。

• Machine failure may occur when in touch with liquid or low temperature.

當機械接觸低溫或液體時，容易發生故障。

• Risk of computer failure and hacking issues. 有電腦失靈、黑客入侵潛在危機。

• In 2008, US FDA announced recalls of a particular liquid nitrogen storage device due to the hazard of electricity leakage.

於 2008 年某種機械液態氮儲存糟因有漏電危險，曾被美國食物及藥物管理局宣佈公開回收。

Storage media characteristics儲存媒介特性

Record of cross-contamination交叉感染紀錄

Recognition認受性

Control difficulty監控難度

Potential of machine failure

機械故障危機

Recall record回收紀錄

• MVE system does not rely on mechanical parts e.g. robotic arm to operate (no electricity is required for operation of MVE tank).

MVE 儲存缸無須依賴機械組件如 : 機械臂操作 ( 操作 MVE 儲存缸無須使用電力 )。

• No.

無。

• Design of the vapour freezer’s lid allows operator to monitor and arrange cord blood units properly with ease. Clients’ unique cord blood samples can be retrieved easily anytime.

氣態氮儲存缸揭蓋式設計能讓工作人員輕易地監測及安放臍血樣本，保證可取回屬於客人的臍血樣本。

• Gas is not a media for bacteria transmission, thus it completely eliminates the risk of cross-contamination between cord blood units.

氣體並非理想媒介傳播病菌，能 100% 杜絕臍血樣本交叉感染風險。

• No record.

無交叉感染紀錄。

• Over 99% of private cord blood banks worldwide including Cord Blood Registry and Viacord use vapour freezers only. Client accountability is important for private banks as the cord blood units are legally owned by clients.

全球超過 99% 的私營臍血庫包括美國儲存量最大的兩間私營臍血庫 Cord Blood Registry 及 Viacord 只採用氣態氮儲存缸，由於法律上臍血樣本屬於客人，所以私營臍血庫須為每一位客戶及其臍血樣本負責。

MVE Anti-contamination Vapour-phaseLiquid Nitrogen Storage System

MVE抗感染氣態氮儲存系統

Robotic liquid nitrogen storage tank機械液態氮儲存糟

15


The term “Transient Warming Events” (TWEs) has been used to describe the exposure of frozen cord blood units to ambient temperature. Some cord blood banks claim that TWEs can significantly affect cell viability and function, which in turn can lead to a poor or failed cord blood transplant outcome. However, literature searches in PubMed and other search engines did not yield articles on the subject of the effect of TWEs on cord blood.

According to a study on the effect of TWEs on cord blood units from the Abstract Book of New Jersey Stem Cell Research Symposium, the results showed that the samples exposed to TWEs and those not exposed to TWEs were not statistically significant and the viability of the cells remain unchanged. The researchers concluded that the belief that brief exposures of cord blood to ambient air causes irreversible damage is not supported by the evidence1.

所謂「短暫熱效應」(TWEs)是形容冷凍的臍血樣本曝露於室溫。有些臍血庫聲稱短暫熱效應可以嚴重影響細活性和功能，導致臍血移植效果不佳甚至失敗。然而，在PubMed生命科學文獻索摘資料庫及其他搜索引擎並未能檢索相關的文獻。

根據美國新澤西洲幹細胞研究研討會會議手冊，一份針對臍血短暫熱效應的研究測試結果顯示，受短暫熱效應及未受短暫熱效應影響的臍血樣本的數據於統計學而言並無差異，而細胞的活性則維持不變，研究人員的結論是，臍血樣本因短暫接觸室溫而造成不可逆轉的損害是毫無根據的說法1。

Lack of scientific proof on the effect of Transient Warming Events (TWEs) on umbilical cord blood units:短暫熱效應影響臍血樣本缺乏科學根據：

Cordlife uses U.S. F.D.A-approved cryobag for storage 康盛人生使用美國食物及藥物管理局認證的抗凍袋

Dual-compartment storage allows multiple applications in the future such as stem cell expansion. 雙間隔抗凍袋設計容許臍血作多次使用，例如幹細胞再生。

Specially designed small tubes for testing cord blood in the future without the need to thaw the entire cord blood unit. 特別設計幼管部份作將來測試之用，無須將整份臍血溶解。

Eliminates sample mix-up. 杜絕樣本混淆機會。

Transplant-ready. 可即時作移植之用。

According to documentation in scientific literatures, stem cell samples stored for about 15 years appear identical to samples stored for one week2. If properly stored at cryogenic temperatures below -135˚C, it is believed by the scientific community that cord blood can be stored indefinitely.

臍血幹細胞在攝氏零下 135 度以下的低溫下可作無限期保存。根據科學文獻紀載，一個已保存 15 年的臍血幹細胞樣本與儲存一星期的樣本相比，兩份樣本均擁有相同的活性 2。

Sources / 資料來源：1. Mrowiec ZR, Angelina A, Laluf J, et.al. 2008. Transient Warming Events and Cryogenic Storage of Cord Blood Stem Cells. New Jersey. Stem Cell Research Symposium. 36-37. 2. Broxmeyer HE, Srour EF, Hangoc G, et. Al. 2002. Proceedings of the National Academy of Sciences of the United States of America. 100/2. 645-650.

How long can I store my baby’s cord blood unit?臍血可儲存多久?

Meets BOTH AABB and FACT-Netcord standards.符合AABB及FACT-Netcord標準


16

Steps of cord blood processing and storage處理和儲存臍血幹細胞流程

Prior to cord blood processing, the identity of the cord blood collected is verified by our laboratory technologist to ensure that the unit belongs to the right client. After the identity verification step, the sample is transferred to the biohazard safety cabinet and a small amount of cord blood is extracted for testing.

處理臍血前，實驗室人員首先會核對樣本身份以確保樣本是屬於正確的客戶，客戶身份經核實，樣本會被放入生物安全操作台抽取少量臍血進行化驗。

The laboratory technologist connects the blood bag and the single-use processing kit to our fully automated processing system, Sepax®2.

實驗室人員將血袋連同一次性使用的處理組件放入 Sepax®2全自動化臍血處理系統。

Sepax®2 will then embark on a fully automated processing step to isolate stem cells contained in the cord blood from other unneeded components such as red blood cells and plasma. During this step, all the stem cells are automatically transferred into a connecting multi-compartment cryobag.

Sepax®2 進行全自動化幹細胞採集，將臍血幹細胞與其他不需要的成份如紅血球及血漿分離。這個步驟會自動將幹細胞轉移到接駁的多間隔密閉式抗凍袋。


17

Steps of cord blood processing and storage處理和儲存臍血幹細胞流程

Upon the completion of the processing step, the multi-compartment cryobag is detached from Sepax®2 and is placed into Coolmix, an automated mixing and cooling device that allows controlled and consistent preparation of stem cells for cryopreservation. During the addition of cryoprotectant solution, the Coolmix constantly mixed the buffy-coat to ensure homogeneous injection while keeping the cryobag at a constant and pre-defined temperature.

完成幹細胞採集後，抗凍袋將與Sepax®2 分離並置入 Coolmix 儀器。Coolmix 是一個混合及降溫的儀器，能為幹細胞長期低溫儲存前作穩定及受控制的準備。於 Coolmix 內，幹細胞不斷與慢慢加入的抗凍劑混合，同時保持在一預設及穩定的溫度。

Once the cryoprotectant solution has been added, stem cells are frozen gradually in controlled-rate freezer, where the temperature is lowered by 1-2˚C per minute, to preserve the viability of stem cells.

幹細胞加入抗凍劑後，便會放入程控降溫儀以每分鐘 1 至 2 度的速度將幹細胞進行緩速降溫，以保存幹細胞的活性。

The cryobag is transferred to MVE anti-contamination vapour-phase liquid nitrogen storage system for long term cryopreservation at -190˚C.

降溫後的幹細胞移送至 MVE 抗感染氣態氮儲存系統，在攝氏零下 190 度低溫下，作永久保存。

18

5 Simple Steps選用康盛人生，只需5個簡單步驟

To Bank With Cordlife

Step 1: Enrol with Cordlife第一步：與康盛人生登記Call our Cord Blood Banking Consultant at Hong Kong (852) 3980 2888 / Macau (853) 6233 8754 to arrange for a meeting.*If your baby is due within the next 4-6 weeks, please contact us now to ensure all necessary steps are undertaken in time for your delivery.

聯絡我們的臍血儲存顧問香港 (852) 3980 2888 / 澳門 (853) 6233 8754，安排會面。* 若您將於 4 至 6 周內分娩，請立即聯絡我們，以確保所有手續能於寶寶出生前辦妥。

Step 2: Receive your Collection Kit第二步：領取「臍愛盒」Once the enrolment procedure is completed, we will provide you with personalized Cord Blood Collection Kit. The kit will contain everything needed for the collection of your baby’s cord blood as well as maternal blood.

辦妥登記手續後，我們會給予您專屬的「臍愛盒」，用來收集臍血以及母親血液。

Step 3: Inform your O&G doctor第三步：通知主診醫生Inform your O&G doctor that you have enrolled with Cordlife for cord blood collection.

通知您的主診醫生，您已登記康盛人生臍血儲存服務。

Step 4: Bring your Collection Kit第四步：攜帶「臍愛盒」Remember to bring your Collection Kit along with you to the hospital for delivery.

入院分娩時，謹記攜帶「臍愛盒」。

Step 5: Call us upon your arrival at the hospital and after the delivery第五步：入院及產後通知Call us at Hong Kong (852) 3980 2999 / Macau (853) 6233 8754. We will arrive within 12 hours to retrieve the Collection Kit and send the cord blood to our laboratory for processing.

抵達醫院時及分娩後，請致電香港 (852) 3980 2999 / 澳門 (853) 6233 8754，我們將於 12 小時內到達醫院取回您的「臍愛盒」，並送往實驗室處理。

Cord Blood Collection Kit 臍愛盒（臍血用）

DCR No.1611 CLHK_BK_v6.6_201402

Hong Kong 香港:(852) 3980 2888 Macau 澳門: (853) 6233 8754

24 HOUR HOTLINE24小時熱線

MainOfficeandLaboratory/香港總辦事處及實驗室Units G11-12 &15, G/F., Biotech Centre 2, No.11 Science Park West Avenue, Hong Kong Science Park, Shatin, New Territories, Hong Kong香港新界沙田香港科學園科技大道西11號生物科技中心2座地下G11-12及15室Tel / 電話: (852) 3980 2980

MacauRepresentativeOffice/澳門辦事處Rua De Coelho Do Amaral, No.91 R/C Macau澳門連勝街91號廣宜居地下A舖（鏡湖醫院對面）Tel /電話: (853) 2835 2266

Documents

Cordlife Educational Booklet - Cord Blood