BIO Deutschland Calls on Amendment of the Stem-Cell Act - Stem Cells: Yes to Research, but no Therapy?
Berlin (February 7, 2005) - Most of the human embryonic stem cell lines created so far are apparently unsuitable for therapeutic uses. Scientists from the team of Dr. Ajit Varki at the University of California, San Diego, have recently succeeded in identifying compounds present on human embryonic stem cells that are currently in use - also in Germany (published in Nat Med 11, 2005, p. 228). Upon implantation these cells would most probably be rejected in the patient.

Many patients, especially those with neurodegenerative diseases (that is Parkinson's and Alzheimer's disease or multiple sclerosis), and researchers had put high hopes in the therapeutic application of human embryonic stem cells. There would be the option however, to use un-contaminated stem cells, if it was not for the ban on their creating and importation in Germany.

Two German laws regulate research on and with human embryonic stem cells: the Embryo Protection Act ("Embryonenschutzgesetz" or EschG) from 1991, and the complementing Stem Cell Act ("Stammzellengesetz" or StZG) to ensure the protection of the embryo, from June 2002. According to these laws importation and application of human embryonic stem cells for research purposes are only permitted if the respective stem cell lines were created before January 1, 2002 - which represents a completely arbitrary qualifying date.

Varki's research team had found out that the stem cell lines concerned took up certain sugar molecules during proliferation from animal components in their culture media (for example foetal calve serum or connective tissue cells from mice). The molecules in question are sialic acids, which upon transplantation would be responsible for the rejection reaction within the patient.

Against the background of the current excellent advances of German research and development teams at biotechnology companies and scientific institutions the industry association BIO Deutschland as the representative of the biotech sector calls on the legislature to amend the so-called Qualifying Date Rule (or "Stichtagsregelung") of 2002. "Looking at these latest findings we must not endanger Germany's internationally brilliant standing in the field of regenerative medicine with prohibitive laws, and thereby put the break on the development of this sector of the life sciences," said Dr. Peter Heinrich, Chairman of BIO Deutschland.

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The Biotechnology Industry Organization Deutschland (BIO Deutschland) has the objective to support and promote in Germany the development of an innovative industry sector based on the modern biological sciences.


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Contact:
Dr. Pablo Serrano
BIO Deutschland - Administrative Office
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