MINUTES OF THE MEETING
Chairman :Dr med. Yongyudh Vajaradul –Director Bangkok Biomaterial Center.
Chief Guest :Prof. Rudiger Von Verson - IAEA Expert
Members Present:Prof. Surasak Muangsombat -Chairman Div of Plastic Surgery, Dept of Surgery.
Dr. Somboon Kunathikon - Associate Professo Infertility Division.
Prof Surapol Issaragraisil - Professor Dept of Medicine
Dr La-Onthong Vajarabhaya - Associate Professor Operative Dentistry, Faculty of Dentistry.
Dr Wisuda Suvitayavat - Assistant Professo Dept of Physiology, Faculty of Pharmacy.
Dr Adisak Wongkajornsilp - Lecturer Dept of Physiology, Faculty of Medicine
Dr Pravit Akarasereenont - Lecturer Dept of Physiology, Faculty of Medicine
Dr Somsak Masomboon - Assistant Professor Division of Plastic Surgery, Dept of Surgery
Dr Pinnita Prabhasawat - Assistant Professor Dept of Ophthalmology
Ms Suwanna K. Suwanawong - Scientist Research unit, Faculty of Dentistry
(Note: All the members are from the Siriraj Hospital, Mahidol University, Bangkok, Thailand).
The meeting was called to order by Dr Yongyudh Vajaradul at 9.00 A.M at the Bangkok Biomaterial Center Conference Room, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Subject: Dr Rudiger Von Verson – expert IAEA visit to Thailand from 2.12.98 - 4.12.98 at the Bangkok Biomaterial Center, Bangkok, Thailand.
1.To discuss in detail & Review the progress of the Project for the establishment of the Tissue Culture laboratory which will include Burn Culture, Cell Culture, Cell Transplantation and Sperm & Bone Marrow Bank.
2.To request the IAEA in supporting the project through financial grants in the form of equipment's, training of lab staffs & technicians at overseas centers and sponsorship of Post Graduate students to overseas expert centers in the above mentioned fields.
A. Major issues:
1. Dr Yongyudh Vajaradul introduced the members to the Chief Guest - Dr Rudiger Von Verson and gave a brief glimpse of the Project -Tissue culture Laboratory. He informed about the progress made in this direction and also the problems encountered during the establishment of the above said laboratory which is still way beyond completation.
2. Dr Rudiger Von Verson thanked Dr Yongyudh Vajaradul and the members present for giving him the invitation and opportunity to speak. He gave a lively and very impressive lecture on the Tissue Culture Laboratory (TCL). His speech was divided into two parts viz. : 1. Methodology, Quality Assurance of Tissue Banking and Regulations at his institute. 2. Profile of the DIZG German Institute of Cell and Tissue Replacement, which is divided into three departments' viz.: a). Tissue Bank b). Dept for Cell Culture c). Dept of Cryo-preservation of Cells & Tissue.
He stressed the need for quality control as in his country there is very strong quality control law governing the Cell & Tissue culture. He talked about the influence Factors, which regulates the work at their institute. These factors are the International recommendations of WHO, IAEA, European Community Recommendation, Convention & Directions. These recommendations lays down the definitions about the quality and structure of tissue banks, they also stress that tissue banks have to be non-profit making Institutions and to be controlled and licensed by the National Health Authorities.
He talked about the Laws & Regulations, which govern the working at their institute and all other institutes of the same field as follows:
1. German Pharmaceutical Law.
2. GMP/GLP, ISO 9000, EC Recommendation 1994, EATB ethical code, EATB general & Special Standards, DIZG QMS manual & Technical manuals.
He stressed the need for public awareness towards the donation of Tissue. He explained the general management system of their institute where they co-operate with the Official – Health in Chief and also the Private Health Organizations as part of Public awareness and Professional awareness to get the donors and to disseminate the information to the public of the importance of tissue donation stressing the point that due to their donations, the surgeons can promise that if we cannot save the live of a patient, we can try to improve the lives of those who need them. Concludingly, he passed on the message that it is not only needed to have a good contact with the people but also with the Ministry of Health. They at their institute co-ordinate with the Dept of Pathology & Forensic Medicine, Obstesteric and Surgery.
He informed that certain external QC & Regulations agencies such as the German Federal Institute control them for Pharmaceuticals & Medical Devices under the German Federal Ministry of Health. The Saxonian health Authorities under whose jurisdiction the location of the Institute falls, conduct surprise visits once in a year to verify and validate the process and techniques as specified under the manuals of the Institute. The products prepared at their institute are covered under as Pharmaceutical products. They also have close co-operations with other advisory boards within their institute viz.: 1) Public Board consisting of representatives from the Public & the church, Politics, Administrations to give advice on ethical points on public awareness, 2) National Scientific Advisory boards which consists of representatives from different fields of surgery who give in there advice on the quality and necessary changes in the Tissues etc. 3) The International Scientific Advisory board where we invite international specialist in the subject to give in lectures, suggestions and comments on the tissue banking.
He also informed that all the Surgeons and Hospitals who are doing transplantation's or cell culture have to be registered with their institute and that they do not supply to anyone who does have a registration. They have a co-operation with about 300 hospitals and 800 Surgeons, who are the users of their institute's products. Talking about the donor screening, he informed that they do not do the HIV testing on the donor tissue without the consent of the donor as it is prohibited under the German Law. The sterilization is carried out with the objective of destroying & eradicating all the microbes without hampering the Biochemical / Biomechanical properties / nature of the material. They follow the BSEN 532 protocol of the ISO 9001 for the sterilization and use 2.9 -> 3.4 Mgr. of radiation.
The Quality management system followed is the ISO 9001, which is universally accepted. At their center they provide the Skin Allograft, Amnion membrane, Keratinocyte cultures, Allogenic and ultralogist Keratinocyte cultures. They have two preservation methods for the Amnion and skin. The skin and Amnion is preserved in Glycerol method (after sterilization of the skin and amnion with the chemical method) it is put into plastic bottles containing 85% Glycerol solution and put it in the refrigerator - 40?C. By this method the preservation can be achieved for about two years. The second type of service provided by their institute is Sperm Banking. This is done especially for people with Tumor diagnosis where the sperm stored can be used for continuing his heritage after his recovery or his death. Apart from the above two services the Institute provides the major services of Tissue & Bone Allografts.
The transportation of Keratinocyte in far of places is done by special transportable incubators, which can carry an approx. of 50 to 60 keratinocytes sheets. The Incubators have their own power supply and can be loaded into an airplane easily for performing a surgery at a hospital. Documentation of all the materials produced is kept from the donation to recipient. Every year their institute prepares an approx. 6000 – 8000 grafts and till date they have transplanted more than 60,000 – 80,000 grafts.
He invited the members of this meeting to attend the Next world Conference & Joint meeting of the EATB and AATB and the APASTB at Warsaw, Poland between October 7 – 10th 1999.
Summary: The lecture of Prof. Rudiger Von Verson was an informative one and intended to indicate the various details of Tissue Banking in a developed country. It showed the various Quality Controls and Administrative protocols i.e. Rules & Regulations a Tissue bank should follow to attain an International Status. It detailed the Co-operation at various levels i.e. Govt., Public, Religious, Social and Scientific, which is necessary for getting donations and supply of the Tissues in its various forms. It also stressed on the need for proper documentations and independent auditing/inspection of the site in order to get a non-partial recognition. He also detailed on the various techniques of processing and storage. The most important highlight of his lecture was that it is only possible to set up a proper Tissue culture laboratory when all the subjects like Tissue & Allograft Banking, Burn Culture Lab, Cell Culture Lab, Cell Transplantation Lab, Sperm Bank and the Bone Marrow bank are at the same premises and subjected to follow an International standard of protocols, Rules & guidelines, which may start from the procurement -> processing -> preservation and Transplantation. It is economically and technically viable to set up the whole project as one piece and one place so as to share the information, equipments, expertise, laboratory, documentation and management.
3. Prof. Surapong explained the work done at their department especially the bone marrow transplant in Thalasemia, Leukemia etc patients. He informed that they had been conducting an extra-dish marrow transplant programme in their dept since the last 12 years. The programme has only being supported by the Government of Thailand. The current programme includes the Allogenic stem cell transplant in several diseases like in acute or chronic Leukemia, Thalasemia and Aplagicaluminia, which is very common in Thailand. The type of stem cell currently used by them is only Allogenic stem cells and mobilized stem cell of the bone marrow instead of bone marrow. The results of this technique is comparable to the bone marrow transplants except the incidence of graft associated disease is relatively higher than the bone marrow transplant. However he said that their programme has not been very successful because with this technique they can treat only patients with multiple lymphoma especially children, in combination with chemotherapy and the result is very poor. All of the patients die within a year. He stressed that with the application of Bone Marrow Transplant the survival rate can be increased upto 90% in Burgit Lymphoma. In other kinds of lymphoma the results of this technique is not very good because the present programme is different to Clot Blood Cell transplant. Since they have many patients where central cell transplant is the only option ex. Thalasemia and also where they can get better results if they transplant earlier.
Summary: Stem Cell from Cloth Blood has promising results and can be used in the place of bone Marrow except in the case where the quantity obtained is very little. They do not have at present any bone marrow donation system, due to lack of pulblicity and public awareness. There is an approximate 60% - 70% of cases who deserve a Bone Marrow Transplantation do not get it due to lack of Bone Marrow. There has been no help / role of IAEA or any other International organization towards there programme. It was agreed upon that it will be in the interest of the bone marrow programme if it co-ordinates with the cell culture lab and is included in the Project of Tissue Culture Laboratory.
4. Prof. Somboon summarized the work at their center i.e. the Sperm preservation. He informed that at present they can preserve the Sperm for only 5 years whereas present preservation technology states that it could be stored for more than a period of 25 – 30 years. He informed that the presently their work is only funded by the Government of Thailand and there is no outside support from International organizations like the IAEA, WHO etc. Hence they lack equipments for processing and storage. Secondly they also lack in the publicity and public awareness due to lack of resources.
5. Prof. Surasak presented Allograft & skin banking and the troubles meted by their department in the processing and storage of the tissues due to lack of equipments and trained lab technicians. He detailed his technique of working with Keratinocytes on artificial skin. He informed that all the laboratory works are presently conducted at the Bangkok Biomaterial Center and he wished to carry out his work over there. He requested the IAEA for supporting the center with some equipments and Training Scholarships for two people at overseas centers.
6. Dr La-Onthong and Ms Suwanna summarized the current status of work at their Department. They indicated that at present they are carrying out the cytotoxicity test for foreign products entering into Thailand and the Ovarian Cell culture. They also indicated that at present no skin culture is carried out at their department due to non-availability of equipments and trained staffs.
7. Dr Wisuda Suvitayavat presented the details of cell culture carried out at their department.
8. Dr Adisak and Dr Pravit gave a lively description of their work on study of Suppression Immuno therapy in breast cancer and gene therapy. They explained the obstacles and challenges faced by them in the cell culture. They explained their work on mutated Mitochondrial DNA. They indicated the lack of trained personnel and shortage of equipments as the major problem.
9. Dr Pinnita gave an excellent presentation of her work in the application of fascia lata and Intra-ocular Implant made from bone substitutes in Ophthalmic Surgery.
10. Dr Yongyudh took the guest and members present at the meeting for a laboratory visit and showed them the present facilities available at the Bangkok Biomaterial Center.
Resolution: The following meeting ended with the final resolution as follows
1. The Project of Tissue Culture Laboratory should be an integrated system and have a National Outlook.
2. All the subjects like Tissue & Allograft Banking, Burn Culture laboratory, Cell culture Laboratory, Cell Transplantation Laboratory, sperm Bank and the Bone & Marrow transplantation banking share the same facilities as many of the equipments are common to all, also that trained technical staff will be limited. Apart from the mentioned benefits it will be economically viable also to setup the various labs under the project and have them banked at one place.
3. The project needs financial support of IAEA through the purchase of equipments. A list of which had been handed to Prof. Rudiger Von Verson to be submitted to IAEA.
4. The project needs IAEA support in the form of Scholarships and Sponsorships of Postgraduate students and lab personnel in the subjects as described above at overseas expert centers.
Vote of Thanks: The meeting was concluded with an address by Dr Yongyudh Vajaradul on behalf of the members present to Prof. Rudiger Von Verson and thanking him for coming to Thailand. The members also thanked Prof. Von Verson for the excellent dissemination of knowledge on Tissue and Cell culture.
The post Lunch session was associated with a visit to the Department of Physiology, Faculty of Pharmacy, Siriraj Hospital.
Minutes recorded & prepared by: Mr. REYAZ ALAM QAYAMI
Research & International Relations Co-ordinator,Bangkok Biomaterial Center