Updated: Feb 1, 97
EMDIS

Project Code:   A2006 Project value:   2646 KECU EC contribution:   1295 KECU No of partners:   3 No of countries:   3 Duration:   42 months

Contact: Prof. Colette Raffoux France Greffe Et Moelle Hosp. Saint-Louis 1 Av. Claude Vellefaux F-75010 Paris, France Tel.: +33-1-42.49.40.70 Fax: +33-1-48.03.02.02

Overview

Purposes, goals, objectives

To do this, EMDIS had the goal to integrate the databases of 12 European bone marrow donor Registries, allowing a smooth data flow from and to extremely heterogeneous systems and nation-wide area networks.

Results, exploitations, demonstrator

The main contribution of EMDIS derives from the fact that medical treatment for a patient awaiting bone marrow transplantation (BMT) has been developed at a European level, when this had not been possible at the patient's own national level.

Due to genetic, immunological and economic reasons, no country alone has the resources to build up a national donor Registry of sufficient size for all its patients. In fact, more than half of the unrelated BMTs in Europe have been performed with the donor and patient originating from different countries.

EMDIS has facilitated and streamlined the international cooperation and communication between national Registries of volunteer bone marrow donors in order to provide donors with better matching tissue types in a shorter period of time for patients throughout the European Union. It has harmonised and standardised various aspects in this field on the international level, and it performed R&D in a way to make results easily applicable to other areas of international communication, especially in transplantation medicine.

Tools developed within EMDIS have allowed the building of a fully automated network and communication system between 12 European countries, based on open systems and established standards in software, hardware and communications. It has analysed the medical and technical framework in order to make best use of existing opportunities and to contribute to the creation of improved and equal medical, social, administrative and economic conditions for the- field of application in the community.

The demonstration was set up as follows:

• Computers with EMDIS software were connected by modem to the telephone network, functioning either as the requesting Registry, or as the reporting Registry and vice-versa.
• In each computer was a national pool of donors installed. - A patient search can be run first at national level and secondly at international level.
• Transmission, step by step: EMDIS local front end (ELF), local core, EMDIS communication system (ECS), remote local core and remote ELFE. The different stages of transmission can be followed on the ECS monitor.
• results generated by the remote EMDIS machine will be transmitted automatically to the local EMDIS machine. The same ECS monitor will be used to follow the transmission of messages.

Potential benefits

EMDIS is the first world-wide initiative to take concrete measures in order to substantially improve and facilitate the cooperation of bone marrow donor registries (BMDRs), that from the very beginning rested on international shoulders and is based on the arduous path of democratic consensus finding.

The world-wide community of national BMDRs including the hub committee of the World Marrow Donor Association (WMDA) meanwhile regard EMDIS as a world-wide model for international co-operation.

Technologically, EMDIS has solved problems that were faced in the co-operation of BMDRs around the world. The fruitful intentional atmosphere in the European community and the funding by AIM gave the unique opportunity to meet this challenge here and now. At least in its very own field, the international co-operation of BMDRs, EMDIS has given Europe a leading role in the world.

Future plans: it has been shown that a single collection and cryopreservation of umbilical cord blood gives enough hematopoietic stem cells for engraftment. The clinical experience is still limited, but preliminary results have shown a good engraftment with no or limited GVHD (Graft Versus Host Disease) in several patients transplanted with a matched sibling donor. Several related partially mismatched transplants have been successful. As it appears that the use of matched unrelated adult marrow donors gives an increased rate of severe GVHD there is some hope that the use of neonatal hematopoietic stem cells would decrease this complication.

The establishment of a European Cord Blood Bank for use in matched or partially mismatched transplants has lead to different levels of standardisation :

1. Procedure of collection, volume depletion, cryopreservation and thawing of cord blood.
2. Various criteria for assessing quantification of hematopoietic progenitors, detection of genetic or infectious transmissible diseases.
3. Criteria for donor selection.
4. Ethical and legal guidelines for informed consent, infectious disease screening of the mother and the cord.
5. Data protection.

The specific applications of EMDIS have a market in the Bone Marrow Donor Registries all over the world.

The general applicability of developments such as Flexible Message Language (FML) and the EMDIS Communication System (ECS) makes them suitable for other markets where the safe communication of easily parsable, formatted messages is required. Potential clients for such tools include:

• Cancer treatment Centres,
• Solid organ transplant Centres,
• and so on.

The Cord Blood Bank applications have a specific Industrial Impact concerning the freezing and the storing of the Cord Blood Units.

A European Organisation has been set up in order to develop cryopreservation and delivery procedures.

2) Health/Social Impact.

One of the main effects of EMDIS on the daily work in the search for unrelated Bone Marrow Donors or cord blood units is that for all European patients all donors in the EC are equally accessible.

Furthermore, more than 50% of national patients receive Bone Marrow of cord blood units harvested from International Donors; This expensive connection has as a consequence, the choice of the best donor in each situation, taking into account the social and medical status of the patients.

3) Obstacles and difficulties.

The cohesion effect of EMDIS should have been the involvement of 12 countries. At the present time, due to difficulties of developing Registries in countries such as Greece and Portugal, or implementing EMDIS inside the National Registries, such as in Ireland and Spain, only nine Registries are really connected.

In addition, due to the technical choice, database, communication tools, a more simple technology must be adapted for countries not having sufficient resources to :

• purchase necessary hardware,
• implement hardware and software.

List of Deliverables

Year 1

• Current structures in the participating registries (3/R/P)
• Software requirement definition with reviewed feedback (4/S/P)
• Feasible interfacing techniques to computer systems already in use (6/R/P)
• Software requirements specification (7/S/P)
• Evaluation of tools (7/R/P)
• Functional pilot system (12/P/R)
• Critical review of the pilot system (12/R/P)

Year 2

• Concepts for safety, confidentiality and efficiency in communication (12/R/P)

Year 3

• Remote administration and maintenance in and int. communication system (3/P/R)
• Database and communication system for Bone Marrow Donor Search (7/P/R)
• Critical evaluation of the achievements the functionality of EMDIS (12/R/P)

Year 4

• Current Structures in the participating registries (6/R/P)
• Software requirement definition with reviewed feedback (8/S/P)
• Software requirement specification (10/S/P)
• Functional pilot system (12/P/P)
• Strategy for remote maintenance (6/R/P)

List of Participants

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