Tissue banks are defined as repositories for tissues and organs used
in transplantation and are primarily non-profit entities. Other types
of tissue banks contain skin, tendons and ligaments, heart tissue, etc
for use in medical repair. References to tissue banking and tissue
transplants in Japan are scarce due to the online language barrier and
the overall cultural constraints still looming against transplantation
in that country. The lack of online information is compounded by the
use of the term tissue bank in Japan as a reference to several
entities - research centers which house cell and tissue samples for
genetic research, banks which contain donated organs for transplant,
and a host of eye banks which also contain donated tissues. Add to
this the lack of specific regulations in Japan, and this becomes a
sketchy area without a lot of informative resources.
I have compiled what resources I could find pertaining to both tissue
and organ banks and transplantation issues in Japan. Several links I
found were in Japanese, only, or broken! This proved to be quite
frustrating. Therefore, the information is quite scattered and lacks
cohesiveness - but, it should prove to be a start.
STATUS OF TISSUE BANKING AND ORGAN TRANSPLANTATION IN JAPAN
The World Health publication referenced below has some of the most
up-to-date information on tissue banking and transplant issues in
Japan. I have included some relevant excerpts.
The following excerpts are taken from: "Ethics, access and safety in
tissue and organ transplantation: Issues of global concern." World
Health Organization. Madrid, Spain, 6-9 October 2003
"Issues in tissue banking and transplantation in Japan/Quality
management system." Dr Naoshi Shinozaki
"Tissue banks in Japan are operated by universities or hospitals and
all tissue banks are now united under the Japanese Society for Tissue
Transplantation. Dr Shinozaki stated that banks function with only
basic guidelines regarding fairness and family consent. There is an
absence of comprehensive "legal background" with minimally manipulated
tissue covered under the Law of Infectious Disease.
Problems include a low donation rate and poor public awareness, lack
of unified regulation and unclear distinction between regulation of
tissue versus pharmaceuticals (biologics) materials.
The needs in Japan include promotion of national awareness;
establishment of national and international standards differentiating
between human cell-based medical devices and tissue for
transplantation; and a government-regulated quality system."
(Please note (my note!) - a huge source of frustrations is that the
"Japanese Society for Tissue Transplantation" has no website!!
Therefore, a potentially valuable reference is nowhere to be found!)
"Japan?s organ transplantation policy and the necessity for
comparative study" - Dr Tsutomu Iuchi
"Dr Iuchi presented an overview of Japan?s Organ Transplantation Law, passed in
1997, which includes the procedure for diagnosis of brain death and
removal of organs. Despite this there is continuing public reluctance
for cadaveric donation and transplantation with only 25 reported
instances of heart beating cadaveric donation since the enactment of
the Law. A public opinion poll reveals that 54% of respondents believe
that "both donor?s positive will and family?s consent" is necessary.
Only 27.6% believe that "only donor?s positive will" is sufficient to
recover organs. "Comparative studies looking at organ donation systems
and public opinions among WHO Member States" are needed.
"Basic requirements for organ transplantation." - Dr Ryota Shirakura.
"Dr Shirakura reported that Japan has performed 15,113 renal
transplants since 1964, 2411 liver transplants since 1989, but only 17
heart and 39 lung transplants since 1998. The organs have largely been
obtained from living and to some extent from non-heart beating donors.
There still remains an extreme donor shortage from brain dead donors.
It is believed that the strict Japanese Transplantation Law, although
addressing brain death criteria, may have reduced these donation
rates. Consent largely for non-heart beating
donation leads to high rates of primary non-function and death is
frequent on the heart and lung transplant waiting lists. Patients with
failure of the liver or kidney have to rely on nonheart beating or
living donors. He stated that the shortage of deceased donors has
resulted in long waiting lists (currently 12 862 for kidneys) and many
Japanese travel abroad for transplantation through arrangements with
foreign transplantation services where they are included in waiting
lists. This is the case in particular for children under 10 years of
age as the transplantation law in Japan does not allow organ donation
by persons younger than 15 years old."
"Japanese approaches to xenotransplantation." - Dr Tadahito Kanda
"Dr Kanda reported that the first Japanese Public Health Guidelines on
the issue of potential infections related to xenotransplantation were
published on 9 July 2002. The guidelines made note of the prior
treatment of patients with cells exposed to mouse keratinocytes and
supported the accumulation of data from all human clinical trials as
the most effective basis for understanding the risks. Dr Kanda
recommended "flexibility" in formulating global guidelines depending
on the nature and type of xenotransplantation. He also emphasized the
need for an international database on infections following
Some more information about tissue banks can be found in the
following, dated abstract.
"Cell, tissue and organ banks in Japan with special reference to the
study of premature aging." Matsumura T, Mitsui Y, Fujiwara Y, Ishii T,
Shimada H. Jpn J Exp Med. 1980 Oct;50(5):321-8
"Cell and tissue banking facilities exist in Japan in a) 7
laboratories of national institutions, for the conservation of living
organisms, b) the Tokyo Metropolitan Institute of Gerontology,
operating its own bank of cultured human cells for aging research, c)
the Institute of Physical and Chemical Research which is performing
pilot experiments for cell research and cell banking, and d) more than
50 laboratories operating small-scale repositories in the fields of
cancer research, virology, genetics, gerontology, radiation biology,
cell biology, and cell physiology. Except for several eye banks, no
organ banks have yet been developed in Japan. As an example of cell
and tissue banking, some details for studying a premature aging
syndrome, i.e., Wistar's syndrome (WS) is shown. Four cases of
autopsied WS patients and more than 20 clinically traced WS patients
have been reported in Japan. At present, cultured skin cells from more
than 20 WS patients and skin tissues from several WS patients for the
initiation of culture, are on deposit and under investigation."
The following excerpt provides additional information about Japanese
"Toru Ogawa, director of the Educational Programs Division at NHK
(Japan Broadcasting Corp.), reports on the difficulties faced in the
development of Japan's first tissue bank in "Looking Toward an Age
When the Human Body Is a Resource." After obtaining consent from
patients, a tissue bank collects from hospitals human tissue that has
been removed during surgery. The bank then stores the tissue and
provides it to companies and research institutions with the goal of
aiding the development of medicines and regenerative therapies, which
involve replacing damaged body parts with cells grown from removed
tissue or with artificially constructed parts, such as skin, bone, or
"According to Ogawa, if Japan allows fundamental patents on these
technologies to go to other countries, the nation is in danger of
becoming a "medical colony." Last year the Japan Health Sciences
Foundation established the Health Science Research Bank in Osaka,
which is supposed to have a tissue bank at the core of its operations.
But a lack of consensus among hospitals has made it impossible for the
bank to obtain tissue. Ogawa stresses the need to create a unified
system of rules governing human tissue, including its use in
commercial products. (Summary of "Jintai shigenka jidai o mae ni,"
Ronza, November 2001.)"
The above excerpt is from "Views from Japan." November 2001. This is a
cached page and you will need to past the following URL into your
browser if you care to reference it online:
The following paper from the World Health Organization states the
difficulty of finding data on tissue transplantation in countries
throughout the world:
From "Human organ and tissue transplantation." Report by the
Secretariat. WHO. 2003.
"The number of human tissue transplants is increasing in both
developed and developing countries, but global data on this form of
transplantation are less complete. In Europe, hundreds of thousands of
tissue transplants are performed each year, and in 1999 an estimated
750 000 people in the United States of America received human tissue,
twice as many as in 1990. Globally, it is estimated that 120 000
corneal transplantations and 18,000 transplantations of allogeneic
haematopoietic progenitor cells took place in the year 2000."
From "Tissue transplantation and banking system in Japan," by Soichiro
Kitamura. The Japanese Journal of Clinical Dialysis Vol.16 No.11."
"Human tissue transplantation is an important therapeutic strategy of
modern medicine. In Japan, various types of tissue transplantation
including skin, cardiac valves, blood vessels, bones and tympanic
bones have been conducted institutionally without public realization
of their importance. It seems to be very diffcult to consider donated
tissue as a material or device for medical use in Japan. Human tissue
should rather be considered as a gift of life, like donated human
organs which are regulated by brain-death legislation."
"At the National Cardiovascular Center, we have set up a modern
laboratory for homograft preservation and established a tissue bank
system in September 1999. Fortunately, following the issue of the new
legislation for organ transplantation in October 1997, the number of
tissue donations has been increasing. Tissue transplantation will
progress along with greater popularization of organ transplantation in
Japan. The establishment of tissue banks is urgently needed in our
It is hard to pinpoint regulations which govern human tissue for
transplantation purposes, primarily pertaining to tissues like
ligaments, cardiovascular tissue, corneas, etc.
As noted in the WHO document above, "Problems include a low donation
rate and poor public awareness, lack of unified regulation and unclear
distinction between regulation of tissue versus pharmaceuticals
I have searched high and low for import regulations and come up
empty. This must be a very confusing area, since I ran across a few
seminars in the course of my research which had sections devoted to
Japanese import regulations regarding human tissue. I might be able to
find them again if you are interested (though they were out-of-date)
* The best way to find out regulations and allowances for importing
human tissues to Japan might be to order the publication listed below:
1. "ADVANCES IN TISSUE BANKING." edited by Glyn O Phillips.
"Advances in Tissue Banking is the only series of publications where
producers and clinical users of tissues can learn in one place about
developments in this interdisciplinary field....It presents the
regulatory controls being introduced in the USA, Europe and Japan,....
Read the preface:
You might want to read the following publications by Glyn Phillips and
Jorge Morales. Despite the mention of Japan in reference to the
establishment of new tissue banks, I was unable to find anything
"CATALYSTS FOR BETTER HEALTH CARE: MEDICAL TISSUE BANKS BRING MULTIPLE
BENEFITS TO COUNTRIES." BY GLYN O. PHILLIPS AND JORGE MORALES
"The International Atomic Energy Agency (IAEA) Programme in Radiation
and Tissue Banking: Past and Present." Jorge Morales. Advances in
Tissue Banking. Vol 7. 2003
You might also find some useful information pertaining to Japan in the
2. "Ethical Issues in Tissue Banking for Research: The Prospects and
Pitfalls of Setting International Standards." Karen J. Maschke and
Thomas H. Murray. Theoretical Medicine and Bioethics. Volume 25,
Number 2. April 2004
"Bauer, Taub, and Parsi's review of an international sample of
standards on informed consent, confidentiality, commercialization, and
quality of research in tissue banking reveals that no clear national
or international consensus exists for these issues. The authors'
response to the lack of uniformity in the meaning, scope, and ethical
significance of the policies they examined is to call for the creation
of uniform ethical guidelines...."
Japanese Import Regulations (another frustrating search!):
I have found nothing pertaining to the importation of human tissue in
the import data. Regulations for all manner of imports can be found on
the Japan External Trade Organization website but I found nothing
pertaining to human tissue.
TISSUE BANKS - Websites
While the excerpts above mentioned the uniting of tissue banks under
the Japanese Society for Tissue Transplantation, there is no website
for this organization, and virtually no information about it!!
Since references to tissue banks in Japan include many types of organ
and tissue banks, I have simply included whatever references have
popped up in English - which are very few!
The following list is very limited due to language barriers and
outdated, broken links. Some of these references are taken directly
from "translated" websites so they might be a bit nonsensical.
One contact, which might prove to be very valuable in pointing you to
Japanese tissue banks, is referenced below:
Japan Society of Bone Joint Soft Tissue Transplantation
Mail address none
Universtity of Tokyo Tissue Bank
Inside the University of Tokyo medical department
hospital TEL: 03-5800-8736 (transplantation coordinator direct
communication) (9:00 - 18: 00)
Donor information: 090-3092-7330 (24 hours) / FAX:03-5684-3989
(Click on Home on the link for address information)
District 330-B Kidney and Eye Bank
Sogo Iryo Kaikan 5F
Japan Health Sciences Foundation Health Science Research Resource Bank
Independent Administrative Institution, Japan Science and Technology Agency (JST)
The National Institute of Cardiovascular Center Tissue Bank is also
under this same phone contact:
Japanese Eye Banks
A list of over thirty Eye Banks in Japan (with full contact details)
can be found by clicking on the top left link on the following page:
Chiba Cancer Center Research Institute
"Our institute is now the central tissue bank for both neuroblastoma
and hepatoblastoma in Japan."
Home page has no contact information
A reference to the Division of Tissue Transplantation and Engineering
can be found on the Creative Research Initiative page:
Tissue Transplantation & Engineering
Aichi Bone Bank
TEL (052) 764-2145
FAX (052) 751-8178
The following link provides a list of medical school names and
addresses in Japan. Since medical schools are listed as the primary
tissue bank repositories, these contacts might be helpful for further
information. All the sites are in Japanese or have very limited
HEALTH SCIENCE RESEARCH RESOURCES BANK
Health Science Research Resources Bank (HSRRB)
Rinku-Minamihama 2-11, Sennan-shi, Osaka 590-0535, Japan
HUMAN GENETIC DATABASES IN JAPAN
7.6 In response to a MHW report in May this year, Japan's biomedical
research infrastructure is to be consolidated, with JHSF setting up
the Health Science Research Resources Bank (HSRRB) in Osaka. This will
be the first public tissue bank in Japan. Tissues within HSRRB will be
confined to those removed during operations
1) Human Tissue Bank
Effort will be made to increase the number of medical organizations
that could provide specimen to expand HSRRB. Reviews will be made
about the roles and tasks of the Foundation regarding challenging
issues of the research use of tissues driven from autopsy corpuses and
of organs/tissues incongruent for implantation. Another effort will be
made to establish a system for supplying and accepting the specimen
smoothly. Further, a possibility of the bank as a cell and tissue bank
for regenerative medicine will also be discussed.
ORGAN TRANSPLANTATION IN JAPAN
The Japan Organ Transplant Network website contains a comprehensive
overview of transplantation law and issues in Japan.
Japan Organ Transplant Network
Click on all left-hand links for topics
Another good overview on the history of organ transplantation in Japan
can be found in the following document:
READ "Section 4. Promotion of Organ Transplantation and Intractable
Disease Measures." From the Annual Report on Health and Welfare 1999.
The following excerpt illustrates the hesistancy in Japan to perform
transplants, even as recently as 2005.
From "FIRST LIVE-DONOR ISLET TRANSPLANT PERFORMED IN JAPAN." February 2005
"JDRF researcher James Shapiro, M.D., Ph.D., of the University of
Alberta, Canada, in collaboration with a research team from Kyoto
University Hospital in Japan, last month supervised a team that
transplanted islets isolated from a portion of a pancreas removed from
a 56-year-old woman into the woman?s 27-year old daughter, who had
type 1 diabetes and met criteria for islet transplantation.
Dr. Shapiro, who is director of the JDRF Clinical Center for Islet
Transplantation at the University of Alberta,
** said Japan was a good site in which to try a living-donor
procedure because, for cultural reasons, few transplants are performed
there using organs or tissue taken from
Read "Transplant first in Japan."
The following academic paper has a few references to tissue costs in Japan:
"THE HUMAN BODY AS A NEW COMMODITY, " Tsuyoshi Awaya, Tokuyama
University, Japan. http://homepage1.nifty.com/awaya/hp/ronbun/r010.html
NUMBER OF TISSUE AND ORGAN TRANSPLANTS
There is scarce information on the number of transplants performed in
Japan. I have compiled what little data I could find (in English).
1,500 per year - with a waiting list of about 15,000!
From The international Eye Network:
"International Eye Network(IEN)is an organization dedicated to
improving the quality of life by providing access to some of the best
health professionals and medical facilityies in the world. We believe
that good htalth is the foundation of true happiness. IEN will provide
information to enable Japanese ophthalmologists to refer their
patients to an ophthalmologist in the U.S.A. who is qualified to
perform corneal transplant surgery and other eye procedures utilizing
the most advanced technology available in modern medicine."
"Due to a shortage of donated tissue in Japan, there are currently
15,000 people on a wating list for corneal transplant surgery. Only
1,500 corneal transplants are performed annually in Japan, compared
with 40,000 in the U.S.A. This means that the majority of people
suffering from diseased and damaged corneas will have to wait
indefinitely to undergo operations in Japan."
International Eye Network
Shatelet Yoyogi 1103 4-27-13 Sendagaya
Shibuya, Tokyo 151-0051 Japan
TEL: 81-3-5414-5589 FAX: 81-3-5413-2929
There is definitely import of donated corneas into Japan, but I could
find no information on numbers or import regulations:
From "The Face of Global Trade: Northwest Lions Foundation."
"The Northwest Lions Eye Bank..is the single largest cornea provider
in Germany and provides almost one-third of all tissue for transplants
See "Corneal transplants attract Japanese patients to Denver," by Amy
Fletcher. The Denver Business Journal - December 13, 2002
The following excerpt is From "DISCUSSION PAPER ON OPTIONS FOR
STRUCTURING HUMAN TISSUE CENTRES IN AUSTRALIA." Barbara Whitlock.
Sponsored by The Menzies Foundation. 1999
2. "Cost effectiveness in Japanese eye banks", Cornea, March 1997.
"The first eye banks were founded in Japan in 1963, and by 1995, their
number had increased to 50. The average number of processed corneas in
each eye bank was only 44 in 1993. A survey was conducted to which 41
banks responded categorised into:
group I - those which are self-sustaining (supported by local Lions
Clubs), 29 banks;
group II - those which are part of and largely funded by a university
and eye banks, 8 banks; and
group III - those that are part of multitissue banks and whose budgets
are not separated, 4 banks.
"For group I, the annual budget was divided by the number of corneas
used for transplantation in each eye bank to estimate the cost for
each tissue. The cost per cornea decreased with the increased number
of processed corneas. There was no correlation between the annual
budgets and the cost of a cornea in either group II or group III
banks. The study concludes that the processing fee per cornea is
reduced as the number of corneas processed in each eye bank
Read "Nationwide survey of bone grafting performed from 1980 through
1989 in Japan." Iwamoto Y, Sugioka Y, Chuman H, Masuda S, Hotokebuchi
T, Kawai S, Yamamoto M. Clin Orthop Relat Res. 1997 Feb;(335):292-7.
Read "The start of an islet transplantation program in Japan." Saito
T, Ise K, Sato Y, Gotoh M, Matsumoto S, Kenmochi T, Kuroda Y, Yasunami
Y, Inoue K, Teraoka S. Transplant Proc. 2005 Oct;37(8):3424-6.
BONE MARROW DONATION AND TRANSPLANTS
From "Japan Marrow Donor Program to shorten wait for marrow
transplants." Stem Cell Research News. 08 May 2004
"The Japan Marrow Donor Program (JMDP), a foundation that promotes
bone marrow transplants, has launched a project to shorten waiting
periods. Such transplants are one of the most effective treatments for
leukemia and other diseases. The number of operations that involved
donors who were not blood relatives and were mediated by the JMDP's
bone-marrow bank reached 5,489 in March after the first bone-marrow
operation in 1993.
The number of people who have registered as donors has exceeded
186,000. But not all patients can receive the operation.
The annual number of bone marrow transplants has leveled off at more
than 700, while the annual number of patients is between 1,500 and
Another factor in the drop in transplants is that patients have more
Transplanting cord blood stem cells from placenta and umbilical cords
have the same effect as a bone-marrow transplant. The number of such
transplants are increasing because a patient can be operated on within
Last year, 588 cord blood stem cell transplants were conducted and
have increased in number over the past six months, setting such a pace
that they may outnumber bone marrow transplants for the year.
But Yoshihisa Kodera, a director of the JMDP and chief of the Japanese
Red Cross Nagoya First Hospital's bone marrow transplant center, said,
"Although some medical facilities have had success with cord blood
stem cell transplants, I believe bone marrow transplants are more
reliable in terms of safety and effectiveness."
"The Japan Marrow Donor Program (JMDP) is a public welfare business
led by the Bone Marrow Transplant Foundation under the supervision of
the Ministry of Health with the cooperation of the Japanese Red Cross
Society operating the Bone Marrow Data Centre at its Central Blood
Centre where the compatibility of the HLA type of a prospective marrow
donor(s) and the HLA type of a patient is checked. Meanwhile, the
Japan Marrow Donor Foundation conducts bone marrow bank businesses
other than those handled by the Bone Marrow Data Centre, acting as an
intermediary between donors and recipients.
SRL contributes in regard to the final verification testing which is
conducted after the compatibility check conducted by the Central Blood
Centre. This testing involves 18 items to check the health of the
blood, HLA and infectious diseases, etc. In the case of a donor and
HLA testing in the case of a recipient."
The "Annual Report on Health and Welfare 1999" contains some valuable
information pertaining to bone marrow, corneal and kidney transplants
in Japan! I was lucky to find something written in English!
Scroll halfeway down the page and start reading at "Systems of Organ
and Bone Marrow Transplant.
Charts for number of transplants (most in Japanese but a few have
A very good overview of transplantation issues in Japan can be found below:
"Brain Death and Transplantation in Japan." International Network for
Life Studies. http://www.lifestudies.org/specialreport01.html
Also read "Japan and Organ Transplants."
Read "Baby's six-organ transplant, banned in Japan, done in U.S." The
Japan Times: Jan. 16, 2005
Only the cached version of this file exists. If it does not load,
please type the title into your browser:
"5.2. Can the "Japan organ transplantation law" promote organ
procurement from the brain dead?" Alireza Bagheri, M.D. pp.133-137 in
Song, SY, Koo, YM & Macer, DRJ. eds. Bioethics in Asia in the 21st
Century (Eubios Ethics Institute, 2003).
"Editorial - Current Status of Lung Transplantation in Japan." Ann
Thorac Cardiovasc Surg Vol. 8, No. 3 (2002)
"Problems concerning brain death and organ transplantation in Japan."
You might be interested in reading these additional publications
concerning transplant issues in Japan from PubMed:
I hope the information provided helps you to form a picture of issues
surrounding tissue and organ transplantation in Japan. If you need
up-to-date information concerning import regulations, I again
recommend that you consider purchasing the book by Glyn O Phillip on
Tissue Banking or contact the Japan Society of Bone Joint Soft Tissue
tissue banks AND Japan
tissue banking AND Japan
Japanese tissue banks
site:..jp tissue bank
provide or Provides transplant tissue to Japan
japan import regulations
import tissue grafts to japan
importing human tissue to Japan
exporting human tissue to Japan
definition of medical device Japan
importing human tissue OR organs to Japan
transplantation in Japan
Japanese transplant tissues
cornea transplants AND Japan
tendon transplants Japan
bone grafting in Japan
importing corneas to Japan
2002 Japanese Pharmaceutical Affairs law
Japanese Society for Tissue Transplantation
IAEA Tissue banks AND Japan
import laws Japan
international organ and tissue donation