PRESS STATEMENT

MINISTER OF HEALTH, MALAYSIA

1^ST NATIONAL STEM CELL CONGRESS

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1.         Stem Cell  Services in MOH Hospitals

1.1       In 2009, a total of 213 haemopoitic stem cell transplants had been performed and registered in this country. The vast majority (87.7%) were performed in public/university hospitals. The single largest centre was Hospital Ampang, which contributed to about 40% transplants in 2009.

1.2.      The majority of all transplants were for malignant disorders and most of these are haematological malignancies such as leukaemia (42%) and lymphoma (32%). The main non-malignant disorders transplanted were thalassaemia and aplastic anaemia (6% each). In 2009, 43 of the 213  transplant recipients died, mostly  due to their underlying disease (63%) and infection (28%).

1.3       Currently, there are 11 Haemopoietic transplant centres performing haemopoietic stem cell transplants (HSCT)  in Malaysia.  These are :

i.    Ampang Puteri Specialist Hospital

ii.   Division of Haematology, Department of Medicine, University of Malaya Medical Centre

iii.   Haematology Department, Hospital Ampang

iv.   Haematology Department, Sime Darby Medical Centre Subang Jaya

v.    Haemapoietic Stem Cell Transplant Unit, Hospital Universiti Sains Malaysia

vi.   Maybank BMT Centre, Universiti Kebangsaan Malaysia Medical Centre

vii.  Oncology-Haematology Department, Gleneagles Medical Centre, Penang

viii. Oncology-Haematology Department, Lam Wah Ee Hospital

ix.   Paediatric BMT Unit, Department of Paediatrics, University of Malaya Medical Centre

x.   Paediatric BMT Unit, Institute of Paediatrics, Hospital Kuala Lumpur

xi.  Paediatric BMT Unit, Sime Darby Medical Centre Subang Jaya

1.4       There are 8 bone marrow transplantors (haematologists with one year training in transplantation) in the Ministry of Health comprising 5 adult transplantors and 3 pediatric ransplantors. The commonest reasons for bone marrow transplants are acute and chronic leukaenmias (49%), lymphomas (17%) and thalassaemias (10%). Other causes include myeloma, bone marrow failure, myelodysplastic syndrome and solid tumours.

1.5       In private hospitals, the cost of transplant  Allogeneic PBSCT ranges from RM 200,000 to RM 250,000. Through Tabung Bantuan Perubatan, the Ministry of Health is subsidising HSCT done in University hospitals at RM 40,000 - RM 60,000 per transplant. 

1.6.      Hospital Ampang Clinical Stem Cell Services

It was established in November 2006. An all-new transplant ward was strengthened in July 2008 with 10 transplant rooms, 6 post transplant rooms and 2 suites.

At present  Hospital  Ampang is able to carry out 180  transplants/year since 2010 compared with only 40-45 transplants previously.  Waiting time is now less than 2 months (compared to 6 months when the service was started), mainly to allow time for donor and patient workup. Emergency cases like bone marrow failures can be accommodated within 2 weeks once a donor is identified. From 1999 to 25 October 2012, 834 adult transplants have been done in this unit with 443 autologous transplants, 359 allogenic-fully matched sibling, 18 allogenic-matched unrelated and 7 cord blood transplants.

1.7.      Hospital Penang Clinical Stem Cell Services

To reduce waiting times, in August 2008, a second KKM adult facility was established in Pulau Pinang Hospital with 2 rooms. It has carried out  55 autologous transplants up to October 2012. 1 haematologist (bone marrow transplantor) will be sent to Hospital Pulau Pinang in November this year to start the allogeneic bone marrow transplants.

1.8       Hospital Likas Clinical Stem Cell Services

Hospital Wanita & Kanak-kanak Likas will  have  it’s own bone marrow unit in the Nuclear Medicine and Radioterapy Institute and the stem cell service will begin in February 2013 to cater to paediatric cases such as thalassemia, aplastic anemia and malignancies. It has 3 isolation rooms with a capacity to expand further to 3 more isolation rooms if the need arises.

1.9       National Cord Blood Bank in Pusat Darah Negara (PDN), and Kedah

Umbilical cord blood (UCB) has emerged as an alternative source of haematopoietic stem cells. The first Malaysian public Cord Blood Bank  (CBB) was established in July 2001 in Pusat Darah Negara. Following that, CBB in Hospital Sultanah Bahiyah, Alor Star was started in April 2010. Currently, PDN has collected 11,554 units of cord blood and half of them have been successfully processed and stored in Pusat Darah Negara.

1.10    Stem Cell Laboratory in IMR

A clean room facility was established in IMR to support several projects and activities funded by NIH/MOH under the programme to strengthen the stem cell and cord blood banking by the end of 2009.

The IMR has been conducting several research projects involving human embryonic stem cell in collaboration with other institutions in the private sector and also overseas such as :

a) Propagation and expansion of human embryonic stem cell lines (Faculty of Medicine, University of Sheffield, UK/LPPKN) 

b) Cultivation of limbal cells for clinical application in severe ocular surface disorders (HKL/Prasad Eye Institute India)

c) Isolation, expansion and characterization of mesenchymal stem cells from various tissues for therapeutic applications (Stempeutics Research/HTAR, Klang/Ampang/HKL)

d) Derivation of human embryonic stem cell lines (Stempeutics Research/HTAR, Klang)

2.   Advances in stem cell therapy and research in Malaysia

Stem cell therapy in Malaysia is developing well in MOH hospitals as well as university hospitals. The number of patients receiving bone marrow and stem cell transplantation for leukaemias and solid tumours, where indicated, are increasing.

Many local institutions are already embarking on stem cell research with funding from the Ministry of Science, Technology and Innovation (MOSTI) or the MOH. Researchers include those from IMR, UKM, UMMC, UPM, USM and other institutions. Many are studying the biology of stem cells, characterisation, genetic stability as well as the differentiation into many different cell types including heart muscle, neurons, liver, kidney and also cartilage. There are also institutions that are working with the industry (stem cell companies) in joint research as well as possible manufacturing opportunities.

3.   Guidelines on stem cell research:

The  Ministry of Health is taking the lead to regulate this important field of research. The guidelines will provide the framework for researchers, clinicians and companies involved in research, clinical trials as well as manufacturing of stem cells. They shall show evidence of safety, quality and efficacy before use in humans. There is a need to protect the public and the patients from harm and the unregulated use of stem cells. The four (4)  guidelines produced by Ministry of Health are:

1. National Guidelines For Haemopoietic Stem Cell Therapy
2. National Standards For Cord Blood Banking And Transplantation
3. National Standards For Stem Cell Transplantation
4. Guidelines On Stem Cell Research And Therapy

The guidelines were first released in December 2006, with a second edition in July 2009.

At this moment, The Ministry of Health has no intention on having a Stem Cell Act yet. The guidelines on stem cell research sufficiently serve as standards to which practitioners and scientists involved in stem cell research and therapy must adhere in order to ensure that no harm is done to the patients.

4. Proven modalities of treatment and those at the developmental stage.

Proven modalities of treatment include stem cell transplantation for leukaemias, lymphomas, some genetic conditions as well as solid tumours.  Those that are in developmental stage include stem cell treatment for heart failure, stroke, spinal cord injuries, and organ failures. The use of cell based therapies for these conditions must be done strictly under clinical trials. Before the clinical trials, there must be sufficient evidence to show safety, quality and efficacy.