• Image courtesy of Dr Kristen Brennand & Dr Fred H. Gage/ Salk Institute for Biological Studies

    human stem cells 2
  • Image courtesy of Dr Yichen Shi and Dr Rick Livesey/ Cambridge Stem Cell Institute

    human stem cells
About EUCelLEX

The European EUCelLEX Project consists in a full examination of the application of the European rules regarding cell banks together with current practices in respect of the therapeutic use of human cells in the different countries concerned. The purpose is to submit the data obtained to the European Commission for it to draw up legislative measures in line with medical advances in this field.
The EUCelLEX project has received funding from the European Union’s FP7 and is coordinated by Emmanuelle RIAL-SEBBAG (Inserm).

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The first EUCelLEX International Consensus Conference has been held in Toulouse on the 30th and 31st of March 2015.

This event covered a vast range of topics, regarding “How stem cells therapies are reshaping medical & research pathways?

Final programme, presentations and and other relevant information available here!

Authors: Louis Buscail, Barbara Bournet, Fabienne Vernejoul, Gilles Cambois, Hubert Lulka, Naïma Hanoun, Marlène Dufresne, Aline Meulle, Alix Vignolle-Vidoni, Laetitia Ligat, Nathalie Saint-Laurent, Frédéric Pont, Sébastien Dejean, Marion Gayral, Frédéric Martins, Jérôme Torrisani, Odile Barbey, Fabian Gross, Rosine Guimbaud, Philippe Otal, Frédéric Lopez, Gérard Tiraby and Pierre Cordelier.

Article in Molecular Therapy (2015); doi:10.1038/mt.2015.1.

Abstract: This phase 1 trial was aimed to determine the safety, pharmacokinetics, and preliminary clinical activity of CYL-02, a nonviral gene therapy product that sensitizes pancreatic cancer cells to chemotherapy. CYL-02 was administrated using endoscopic ultrasound in 22 patients with pancreatic cancer that concomitantly received chemotherapy (gemcitabine). The maximum-tolerated dose (MTD) exceeded the maximal feasible dose of CYL-02 and was not identified. Treatment-related toxicities were mild, without serious adverse events. Pharmacokinetic analysis revealed a dose-dependent increase in CYL-02 DNA exposure in blood and tumors, while therapeutic RNAs were detected in tumors. No objective response was observed, but nine patients showed stable disease up to 6 months following treatment and two of these patients experienced long-term survival. Panels of plasmatic microRNAs and proteins were identified as predictive of gene therapy efficacy. We demonstrate that CYL-02 nonviral gene therapy has a favorable safety profile and is well tolerated in patients. We characterize CYL-02 biodistribution and demonstrate therapeutic gene expression in tumors. Treated patients experienced stability of disease and predictive biomarkers of response to treatment were identified. These promising results warrant further evaluation in phase 2 clinical trial.

The European Medicines Agency (EMA) has recommended Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, for approval in the European Union. Holoclar is a treatment for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. It is the first medicine recommended for LSCD, a rare eye condition that can result in blindness.

EMA Press release here.

A revolutionary treatment for severe heart failure using embryonic stem cells seems to have worked, with the female patient resuming normal activity. This woman treated with a revolutionary embryonic stem-cell therapy for severe heart failure is doing well three months after the operation.

The patient, 68 at the time of the procedure last October, was given juvenile heart cells that had been grown in the lab from human precursor cells. The young cells were transferred in a gel-laced patch applied to a damaged part of the woman’s heart during bypass.The new technique had not triggered any tumours in animal trials, and the female patient has not shown any negative reaction to the cells or immunosuppressant drugs.

The patient’s cardiologist, Philippe Menasche of the Georges-Pompidou European Hospital in Paris, presented the positive results last week, at the annual meeting of the French Society of Cardiology.

Inserm Press release here.

Authors: A. Mahalatchimy, E. Rial-Sebbag, A.- M. Duguet, F. Taboulet & A. Cambon-Thomsen.

Article in Nature Biotechnology (doi:10.1038/nbt.3105). Reprinted by permission from Macmillan Publishers Ltd: Nature Biotechnology 33,41–43(2015), copyright 2015.

Recent restrictions on the patentability of human embryonic stem cell inventions in Europe necessitate a shift in R&D strategies.

Part of this work is supported by the EUCelLEX project.