2/13/2018 Cell and Tissue Banking - incl. option to publish open access (Editorial Board)

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International Journal for Banking, Engineering and Transplantationof Cells and Tissues Incorporating Advances in Tissue Banking

Editor-in-Chief: R. von Versen

ISSN: 1389-9333 (print version) ISSN: 1573-6814 (electronic version)

Journal no. 10561

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Cell and Tissue Banking

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Editor-in-Chief: Rüdiger von Versen Wandlitz, Germany

Co-Editors: Hans Burchardt Edison, NJ, USA

Moritoshi Itoman Kanagawa, Japan

Jan Koller Bratislava, Slovakia

Anne Lechat Keerbergen, Belgium

Glyn O. Phillips Cardiff, UK

Moshe Salai Beilinson, Israel

Douglas M. Strong Seattle, WA, USA

Assistant Editor: Mark D. Smith, Berlin, Germany

2/13/2018 Cell and Tissue Banking - incl. option to publish open access (Editorial Board)

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Co-ordinating Board:

Rodolfo Capanna European Association of Musculo Skeletal Transplantation (EAMST)

James Forsell American Association of Tissue Banks (AATB)

Jan Wondergem International Atomic Energy Agency (IAEA)

Jan Koller European Association of Tissue Banks (EATB)

Adela Miralles Marin Spanish Association of Tissue Banks (AETB)

Alfonso Moreno Torrico Spanish Interdiciplinary Society of Cryobiology

Paulo Rocha Portugal Association of Tissue Engineering and Banking, Miraflores-Algés, Portugal

Ines Alvarez Latin American Association of Tissue Banks (ALaBaT)

Jan van der Valk European Society for Toxicology In Vitro, Utrecht, The Netherlands

Ruth Warwick British Association of Tissue Banking (BATB)

Chang-Joon Yim Asian Pacific Association of Surgical Tissue Banks (APASTB)

Nathan Keller Israeli Association of Tissue Banks (IATB)

Editorial Board:

Jun-ichi Abe, Houston, TX, USA; Jiri Adler, Miraflores-Algés, Portugal; Allan J. Aho, Turku, Finland;Ana Barac, Washington, USA; Fortunato Benaim, Buenos Aires, Argentina; Alberto N. Bolgiani,Buenos Aires, Argentina; Michael Cahane, Tel-Hashomer, Israel; Robert Combes, Nottingham, UK;Christian Delloye, Brussels, Belgium; Franco Dondero, Rome, Italy; D. Ted Eastlund, St. Paul, MN,USA; Hans-Jürgen Glander, Leipzig, Germany; Lea T. Grinberg, San Francisco, USA; Alan E.Gross, Toronto, Canada; Simone Hennerbichler-Lugscheider, Linz, Austria; Marisa R. Herson,Melbourne, Australia; Ramadan Jashari, Brussels, Belgium; Michael J. Joyce, Cleveland, OH, USA;Artur Marek Kaminski, Warsaw, Poland; John N. Kearney, UK; Astrid Lobo Gajiwala, Mumbai, India;Marti Manyalich, Barcelona, Spain; Pavel Mericka, Hradec Kralove, Czech Republic; Leslie W.Miller, Tampa, FL, USA; David A.F. Morgan, Brisbane, Australia; Arnon Nagler, Tel-Hashomer,Israel; Aziz Nather, Singapore; Reida el Oakley, Riyad, Saudi Arabia; Robert Parker, London, UK;David Pegg, York, UK; Axel Pruss, Berlin, Germany; Hari H. Reddi, Sacramento, CA, USA; PaulRooney, Liverpool, UK; Oscar Schwint, Buenos Aires, Argentina; Fernando Silbermann, BuenosAires, Argentina; Dariusz Sladowski, Warsaw, Poland; Sajio Sumida, Tokyo, Japan; William W.Tomford, Boston, MA, USA; Rafael Villalba Montoro, Cordoba, Spain; William R. Walsh, Sydney,Australia; Lloyd Wolfinbarger, Virginia Beach, VA, USA; Chris Womack, Cheshire, UK; ChunxiangZhang, Chicago, IL, USA

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2/13/2018 Cell and Tissue Banking, Volume 10, Issue 2 - Springer

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Cell and Tissue BankingAll Volumes & Issues

The IAEA Program on Radiation and TissueBanking

ISSN: 1389-9333 (Print) 1573-6814 (Online)

In this issue (18 articles)

1.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Asiaand the Pacific and the Latin American regions

Jorge Morales Pedraza, Glyn O. Phillips Pages 79-86

2.

OriginalPaper

The evolution and impact of the International AtomicEnergy Agency (IAEA) program on radiation and tissuebanking in Asia and the Pacific region

Jorge Morales Pedraza, Glyn O. Phillips Pages 87-91

3.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in India

Astrid Lobo Gajiwala, Jorge Morales Pedraza Pages 93-101

4.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inIndonesia

Su

pp

ort

2/13/2018 Cell and Tissue Banking, Volume 10, Issue 2 - Springer

https://link.springer.com/journal/10561/10/2/page/1 2/4

Nazly Hilmy, Menkher Manjas, Ferdiansyah, Basril Abbas… Pages 103-107

5.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Korea

Yong-Koo Kang, Chang-Joon Yim, Jorge Morales Pedraza Pages 109-113

6.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inMalaysia

Norimah Yusof, Jorge Morales Pedraza Pages 115-117

7.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inSingapore

Aziz Nather, Jorge Morales Pedraza Pages 119-124

8.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inThailand

Yongyudh Vajaradul, Jorge Morales Pedraza Pages 125-132

9.

OriginalPaper

The evolution and impact of the International AtomicEnergy Agency (IAEA) program on radiation and tissuebanking in the Latin American region

Jorge Morales Pedraza, Glyn O. Phillips Pages 133-137

Su

pp

ort

2/13/2018 Cell and Tissue Banking, Volume 10, Issue 2 - Springer

https://link.springer.com/journal/10561/10/2/page/1 3/4

10.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inArgentina

Eulogia Kairiyama, Jorge Morales Pedraza Pages 139-142

11.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Brazil

Marisa Roma Herson, Monica Beatriz Mathor, Jorge Morales Pedraza Pages

143-147

12.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Cuba

Jorge Morales Pedraza, Eddy O. Sánchez Noda… Pages 149-152

13.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Chile

Paulina Aguirre Herrera, Jorge Morales Pedraza Pages 153-156

14.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inMexico

María Esther Martínez-Pardo, Jorge Morales Pedraza… Pages 157-165

15.

OriginalPaper

2/13/2018 Cell and Tissue Banking, Volume 10, Issue 2 - Springer

https://link.springer.com/journal/10561/10/2/page/1 4/4

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking in Peru

Emma Castro Gamero, Jorge Morales Pedraza Pages 167-171

16.

OriginalPaper

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking inUruguay: development of tissues quality control andquality management system in the National Multi-TissueBank of Uruguay

I. Álvarez, Jorge Morales Pedraza, M. C. Saldías… Pages 173-181

17.

OriginalPaper

Training tissue bank operators: the International AtomicEnergy Agency (IAEA)/National University of Singapore(NUS) 10 years of experience

A. Nather, G. O. Phillips, Jorge Morales Pedraza… Pages 183-190

18.

OriginalPaper

A future vision of the International Atomic Energy Agency(IAEA) program on radiation and tissue banking for Asiaand the Pacific and Latin American regions

Jorge Morales Pedraza Pages 191-196

Support

The impact of the International Atomic Energy Agency(IAEA) program on radiation and tissue bankingin Indonesia

Nazly Hilmy Æ Menkher Manjas Æ Ferdiansyah ÆBasril Abbas Æ Jorge Morales Pedraza

Received: 2 June 2008 / Accepted: 2 June 2008 / Published online: 24 July 2008

� Springer Science+Business Media B.V. 2008

Abstract In 1986, the National Nuclear Energy

Agency (Batan) in Jakarta started the research and

development for the setting up of a tissue bank (Batan

Research Tissue Bank/BRTB) by preserving fresh

amnion or fetal membranes by lyophilisation and

then sterilising by gamma irradiation. During the

period of 1990 and 2000, three more tissue banks

were set up, i.e., Biomaterial Centre in Surabaya,

Jamil Tissue Bank in Padang, and Sitanala Tissue

Bank in Tangerang. In 1994, BRTB produced bone

allografts. The banks established under the IAEA

program concentrated its work on the production of

amnion, bone and soft tissues allografts, as well as

bone xenografts. These tissues (allografts and xeno-

grafts) were sterilised using gamma irradiation (about

90%) and the rest were sterilized by ETO and those

products have been used in the treatment of patients

at more than 50 hospitals in Indonesia. In 2004, those

tissue banks produced 8,500 grafts and 5,000 of them

were amnion grafts for eye treatment and wound

dressing. All of those grafts were used for patients as

well as for research. In 2006, the production

increased to 9,000 grafts. Although the capacity of

those banks can produce more grafts, we are facing

problems on getting raw materials from suitable

donors. To fulfill the demand of bone grafts we also

produced bone xenografts. The impact of the IAEA

program in tissue banking activities in Indonesia can

be summarised as follows: to support the national

program on importing substitutes for medical

devices. The price of imported tissues are between

US$ 50 and US$ 6,000 per graft. Local tissue bank

can produce tissues with the same quality with the

price for about 10–30% of the imported tissues.

Keywords IAEA � Tissue banking � Allografts �Xenogarft � Indonesia

The early period

The ‘‘Indonesia 1992 Health Regulation’’ provides

for procurement of tissues from living donors as well

as from deceased donors. Since 85% of the Indone-

sian population is Moslem, a ‘‘Fatwa’’ from Moslem

Religious Council (MUI) for deceased donors should

be obtained. A ‘‘Fatwa for Bone, Skin and Amnion’’

N. Hilmy (&)

Batan Research Tissue Bank, Batan, Jakarta, Indonesia

e-mail: nazly@batan.go.id

M. Manjas

Tissue Bank, Dr. M. Jamil Hospital, Padang, Indonesia

Ferdiansyah

Biomaterial Center, Dr. Sutomo Hospital, Surabaya,

Indonesia

B. Abbas

Batan Research Tissue Bank, Batan, Jakarta, Indonesia

J. Morales Pedraza

IAEA, Charasgasse 3, apart. 13, 1030 Vienna, Austria

e-mail: jmorales_47@yahoo.com; jmorales47@hotmail.com

123

Cell Tissue Bank (2009) 10:103–107

DOI 10.1007/s10561-008-9088-x

was introduced by the MUI on June 29, 1997

permitting tissue procurement from cadaver donors.

The development of all specialty medical field in

Indonesia provide the impetus for providing biolog-

ical tissues for medical treatment, which cause strong

motivation for the development of tissue banking in

Indonesia. This was started before 1990. The National

Nuclear Energy Agency (Batan) Jakarta started the

research and development on the setting up of tissue

bank (Batan Research Tissue Bank/BRTB) in 1986

by carrying out research on preserving fresh amnion

or foetal membranes by lyophilisation and then

sterilising by gamma irradiation. In 1994, BRTB

started to produce bone allograft obtained from live

donors.

In 1992, Dr. Soetomo General Hospital in Sura-

baya set up a bone bank which produced frozen bone

sterilised by ethylene oxide (ETO) and in 2000 it

became The Biomaterial Centre—‘‘Dr. Soetomo’’

Tissue Bank and produced variable tissues sterilised

by irradiation such as: fresh frozen and freeze dried

bone, fresh frozen and freeze dried amniotic mem-

brane, fresh frozen and freeze dried tendon, fresh

frozen and freeze dried fascia. In 1997, a tissue bank

was set up at M. Jamil Hospital in Padang and

produced amnion grafts sterilised by radiation.

Before tissue bank was set up in Indonesia the

orthopedic surgeons used commercial products of

allograft or bone substitutes, but unfortunately, the

price was too high for Indonesian people. This

situation presented a challenge for orthopaedic sur-

geons and other scientists to develop tissue banks in

Indonesia. After tissue banks were developed and

followed by public campaigning, the demanding of

allografts both fresh frozen and freeze dried has

increased very much.

Within the 1990s, four tissue banks were founded

in the state. The IAEA provided financial, technical,

as well as training support for tissue bank staffs and

the users of tissue bank products to consolidate these

four tissue banks:

a) Batan Research Tissue Bank in Jakarta.

b) Biomaterial Center at Soetomo Hospital in

Surabaya.

c) Tissue Bank at M.D jamil Hospital in Padang.

d) Tissue Bank at Sitanala Hospital in Tangerang.

The banks established under the IAEA program

concentrate their work on the production of amnion,

bone and soft tissues allograft, as well as bone

xenografts. These tissues (allograft and xenografts)

were sterilized using gamma irradiation (about 90%)

and the rest were sterilised by ETO. Those products

have been used in the treatment of patients at more

than 50 hospitals in Indonesia. In 2004, these tissue

Banks produced 8,542 grafts and 5,000 of them were

amnion grafts for eye treatment, as well as for wound

dressing. All of those grafts were used for patients as

well as for researches. In 2006, the production

increase up to 9,000 grafts. Although the capacity

of those banks can produce more grafts but we are

facing problems to get raw materials from suitable

donors. To fulfill the demand of bone grafts we also

produced bone xenografts.

In 2003, a bone bank was established in Solo,

Central Java, i.e., at the Prof. Dr. Soeharso Ortho-

paedic Hospital (Hilmy et al. 2007; Hilmy and

Paramita 2006; Ferdiansyah 2006).

Types of graft produced

A. Human bone/allograft

I. Freeze dried tissue

1. Calvarial bone (bi-cortical)

2. Costae

3. Ilium (tri and bi cortical)

4. Cortical strut graft (fibula and costae)

5. Cortical chips

6. Cancellous chips

7. Bone powder

II. De-mineralized and freeze dried tissues

1. Cortical chips and powder

2. Cancellous chips and powder

III. Soft tissues

3. Tendon

4. Facia

5. Amnion

B. Bovine bone/xenograft

1. Cancellous chips

2. De-mineralized bone powder

3. Eye-ball

4. Strut

The type of allograft produced per year can be seen in

Table 1 (those are products, which were produced in

2004). Increasing of products was not significant

104 Cell Tissue Bank (2009) 10:103–107

123

because of lack of suitable donors. In 2006, total

tissues produced were about 9,000 pieces, 90% of

them were sterilised by radiation and the rest by ETO

mostly for frozen bone allograft. Although the needs

for allograft are increasing, those tissue banks could

not fulfil it based on lack of suitable donor.

Xenografts are also produced by BRTB as well as

by Biomaterial Centre, and the number of grafts

produced are around 1 000 graft per year.

Increasing tissue banking activities

and the impact of the IAEA program

The progresses of tissue banks activities are very

much influenced by the rising demand of various

biological tissues, as well as implementation of

quality assurance in all steps of the activities. Having

obtained more than six years experiences (from 1988

to 1994), from just producing amniotic membrane

and storing frozen bone; nowadays there are many

kind of tissue produced such as bone, fascia, tendon

and other soft tissues from selected cadaver and

surgical donor. Established tissue banks perform

good standard procedure of processing, preservation,

and sterilisation as recommended by EATB, AATB,

and IAEA. The production reached 9,000 grafts per

year in 2006, with improving quality of product since

we adopted the organisation and international stan-

dards, as well as good developing processing

techniques learnt from several tissue banks centers.

There was an impact also of the training of seven

tissue bank staffs in the Regional Training Centre in

Singapore; one staff in advance training in Bangkok

and two staffs in North West Tissue Centre, USA.

IAEA also support us by training 20 users of tissue

bank products in several countries like USA.

The impact of the IAEA program in tissue banking

activities in Indonesia can be summarised as follows:

• Support the national program on import substitute

for medical devices. The price of imported tissues

are between US$ 50 and US$ 6,000 per graft.

Local tissue bank can produce tissues with the

same quality with the price for about 10–30% of

the imported tissues.

• Increasing the ability, quality and confident of

human resources, such as operators of tissue

banks and clinical users.

• Confidence in producing any kind of tissue

allografts since we are implementing the IAEA

International Standard in Tissue Banking.

As a result of the IAEA program, at present

Indonesia is applying the following IAEA documents

as well as International standard such as:

a) IAEA International Standard for Tissue bank.

b) IAEA Code of Practice for the Radiation Steril-

isation of Tissues Allografts: Requirements for

Validation and Routine Control.

c) ISO 11137/2006 for Validation of Radiation

Sterilisation Dose.

Since a new ISO 11137 has been established in

2006, we do hope that IAEA Code will be updated

and re-edited in order to be related with this new ISO.

The IAEA program supported the implementation

of one of national project INS/7/003 ‘‘Radiation

Sterilisation of Human Tissue Grafts’’ during the

Table 1 Products of tissue banks (allografts) and their applications in Indonesia in 2004

Types of allografts Tissue banks Number of

allografts

produced

Donors Recipients

BRTB Biomaterial

Dr. Sutomo

Hospital

TB Dr. M. Djamil

Hospital

Cadaver Live

Amniona 650 650 1,300 – 80 120

Amnionb 150 3,000 3,000 6,150 – 460 3,000

Bone allografts 300 700 – 1,000 4 106 600

Tendon/facia 29 63 – 92 – 91

Total 1,290 4,413 3,000 8,542 4 646 3,811

a Amnion for implantation/Freeze dried radiation sterilized amniotic membrane/ALS radiationb Amnion for dressing/Air dried radiation sterilized amniotic membrane/AAS radiation

Cell Tissue Bank (2009) 10:103–107 105

123

period 1995–2000, with a budget of US$ 255,391.

Indonesia also participated in the implementation of

two regional project RAS/7003 ‘‘Radiation Sterilisa-

tion of Tissue Grafts’’ (RCA) during the period 1988–

1998, and RAS/7/008 ‘‘Quality Assurance in Radiation

Sterilisation of Tissue Graft’’ (RCA) during the period

1997–2003, and two interregional projects INT/6/049

‘‘Interregional Centre of Excellence in Tissue Bank-

ing’’ during the period 1997–2003, and INT/6/052

‘‘Improving the Quality of Production and Uses of

Radiation Sterilised Tissue Grafts’’ from 2002 to 2004

(Hilmy et al. 2006; Manjas et al. 2006).

The current situation of tissue banking activities

The established tissue banks in Indonesia can now

produce any type of bone grafts, any kinds of

de-mineralized bone grafts, soft tissue such as tendon,

facia, as well as amnion grafts and any kind of bone

xenografts. These four banks has now eight tissue

bank operators with International certificates and

more than 20 medical personnel working full or part

time. Most of them were trained using several of

IAEA programs, mostly in using bone, soft tissues,

and amnion grafts.

The Indonesian’s authorities are ready to support

the presentation of a program or a project to the

IAEA, in order to consolidate tissue banking activ-

ities in a selected group of countries in Asia and the

Pacific, Europe, and Latin American regions, if the

governments of other countries are prepared to adopt

the same position.

The tissue banks in Indonesia are now cooperating

with other tissue banks in Singapore and Malaysia.

According to the future demand of tissue in the

country, the established tissue banks should concen-

trate their activities in producing bone, soft tissues,

skin, as well as amnion grafts to be used for medical

treatment.

Caused by the increasing demand in tissue bank

products, as stated at the annual meeting of the

Indonesian Association of Tissue Bank (IATB) held

in 2001, it was decided to establish two more tissue

banks at South Sulewesi and Central Java province. In

2003, a tissue bank was established in Solo, Central

Java.

In the opinion of Indonesian’s authorities, the

following factors are limiting the increase of tissues

donors and are affecting tissue banking activities in

the country:

a) Lack of National Coordinators established by

government and interest in becoming donors.

b) Problems of suitable irradiator of Co-60, such as

increasing the Co-60 sources of a Gamma Cell in

Padang. The Gamma Cell was obtained from

IAEA 1996, but now the sources are only

3,000 Ci. Padang is located in Sumatra and about

600 miles from Jakarta. We could not help them to

sterilise their products. We do hope that IAEA will

support us in increasing the Co-60 sources.

c) New Emerging Infectious Diseases caused by

viruses such as avian influenza type H5N1,

Corona virus, West Nile Virus, dengue virus

which make the donor could not be screened

according to IAEA standard. We do hope that

IAEA will held a new project on eliminating

viruses from grafts by radiation.

To overcome these limiting factors the Indone-

sian’s authorities are considering the adoption of the

following actions.

a) Establishing a National Coordinator to support

obtaining suitable donor.

b) Increasing production of xenografts.

c) Joining IAEA new project in tissue banking.

Conclusions

It can be concluded that Indonesia still need IAEA

support to fulfill the increasing demand of tissue

allografts, as well as research on the effects of

radiation on viruses.

References

Hilmy N, Paramita P (2006) New emerging infectious diseases

caused by viruses. In: Nather A, Yusof N, Hilmy N (eds)

Radiation in Tissue Banking. World Scientific, Singapore,

pp 133–146

Hilmy N, Pandansari P, Ibrahim GS, Indira S, Bambang S,

Sunarti R, Herawati S (2006) Use of freeze-dried irradi-

ated amnion in ophthalmologic practices. In: Nather A,

Yusof N, Hilmy N (eds) Radiation in tissue banking.

World Scientific, Singapore, pp 355–364

Hilmy N, Febrida A, Basril A (2007) Experiences using IAEA

code for tissue allografts. J Rad Physc Chem 76:1751–

1755

106 Cell Tissue Bank (2009) 10:103–107

123

Ferdiansyah (2006) Use of freeze-dried irradiated bones in

orthopedic surgery in radiation. In: Nather A, Yusof N,

Hilmy N (eds) Tissue banking. World Scientific, Singa-

pore, pp 317–326

Manjas M, Tarusaraya P, Hilmy N (2006) The use of irradiated

amnion grafts in wound dressing. In: Nather A, Yusof N,

Hilmy N (eds) Tissue Banking. World Scientific, Singa-

pore, pp 329–342

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