Regenerative Medicine

A new company has been set up in the Benelux to discover and develop small molecule drugs for treating bone and joint diseases. It combines assets from TiGenix NV of Belgium and Therosteon BV of the Netherlands.

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US stem cell research involving human embryos received a setback after a US judge ruled that a 2009 Presidential order expanding funding for this research is illegal.

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European researchers have reported that stem cells from the thymus of a rat can be reprogrammed into skin stem cells without the need for genetic modification. The research was published in the journal Nature on 19 August 2010.

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Preclinical research showing that reprogrammed adult stem cells can repair damaged heart tissue in mice has been published in the Journal of the American College of Cardiology. The technology is also being tested in a human trial in Europe.

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Geron Corporation said it has received clearance from the Food and Drug Administration to proceed with a human trial of an embryonic stem cell-based therapy in patients with acute spinal cord injury.

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A novel approach to antibody development has received the backing of the global medical charity, the Wellcome Trust. Kymab Ltd of Cambridge UK has received £20 million in a Series A round to develop its technology platform.

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Scientists from Yale University have shown that lung tissue engineered in a laboratory and implanted into rats can restore partial lung function. The findings represent a first step towards the goal of generating fully functional lungs in vitro.

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EMA prepares for first stem-cell application

The European Medicines Agency is inviting comment on a draft regulatory document for stem-cell therapies ahead of what is expected to be the first ever marketing authorisation application in Europe for such a therapy. At a workshop on 10 May 2010, Thomas Lönngren, the agency’s executive director, said the manufacturer of a stem-cell therapy has signaled its intention to seek approval for the product’s launch on the market. The regulatory review of the product will be informed by the new document, which is open for comment until 30 June. The document describes the proposed regulatory requirements for stem-cell therapies including the quality, non-clinical and clinical aspects. It also deals with subjects such as biodistribution. According to the EMA, there are about 40 clinical trials of stem-cell therapies underway in Europe exploring the regeneration of lost or damaged tissue, and in haematological or solid-organ malignancies. The majority of these trials use mesenchymal cells derived from adipose tissue, bone marrow, stromal cells and connective tissue. A small proportion is using haematopoietic stem cells.

New EU funding for regenerative medicine

The European Commission will be inviting researchers, including companies, to apply for a new tranche of funding in July under its Seventh Framework Programme (FP7). The call will include funds for clinical trials of regenerative medicines and for the application of new tools and technologies to these medicines. According to Charles Kessler, of the Commission’s research division, the new funding will be targeted at small and medium-sized enterprises. There will be a two-step application process, geared to the needs of small companies.

Advantages of iPS cells explained

One of the still-to-be explored applications of induced pluripotent stem cells (iPS) is their use in the treatment of monogenic diseases, according to Marc Peschanski, scientific director of the French research institute, I-Stem. Speaking at a European Medicines Agency workshop on 10 May, Mr Peschanski said iPS cells, which are embryonic-like stem cells created from adult somatic cells, could be used to treat  inherited diseases that are controlled by a single pair of genes. The iPS technology could be used to create a bank of cell lines with different haplotypes which would be compatible with the immune systems of patients in need of a graft. “iPS [technology] allows us to go after specific donors with specific haplotypes,” Mr Peschanski commented.

Call for longer incubation for regenerative medicines

At a time when capital is scarce, inventors of new regenerative medicine technology  should incubate this technology longer rather than rush to start up companies, according to Greg Bonfiglio, managing partner of Proteus Venture Capital. Speaking at a conference in London on 12 May, Mr Bonfiglio said money is tight for all but the most ‘pristine’ technologies and business plans. Investors are less willing to take risks now than before the start of the financial crisis. This means scientists should be keeping their technologies in translation centres for longer, even through Phase 2. Examples of translation centres are the UK’s Medical Research Council, the Fraunhofer Society in Germany and the California Institute for Regenerative Medicine, he said.

Copyright 2010 Evernow Publishing Ltd

More embryonic stem cell lines approved for US funding

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Cellular Dynamics International (CDI) Inc of Madison, Wisconsin has raised $40.6 million in a Series B private equity round to increase production capacity for its human heart cells derived from induced pluripotent stem cells (IPSCs).

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