Geron Corporation announced to have been authorised by the Food and Drug Administration (FDA) to carry on the first clinical trials on man with a line of human embryonic stem cells. It deals with a phase I trial on patients with lesions of spinal cord. The treatment, aiming at restoring the spinal cord, consists in injecting next to the lesion of the patient, oligodendrocyte progenitor cells (cells from the tissue around the nerve cells) derived from human embryonic cells (CSEh). The cell line used (GRNOPC1) comes from the line of H1 human embryonic stem cells, created on 9th of August 2001 by Geron, leader company in research on embryonic stem cells. This line is deemed qualified for human use (normal karyotype and free from animal or human contaminants).
An eventful authorisation
Yet, this authorisation has been granted early 2009 before to be suspended in August 2009. Indeed, the 24 experiments on rats and mice, performed separately by Geron, revealed the occurrence of microcysts at the injection sites of embryonic stem cells. Thus the FDA decided to postpone the clinical trials and to continue the works on animals. Today Geron affirms to have developed new markers and trials which would have been tested on animals successfully.
A controversial trial
In the scientific field, Geron’s clinical trial is far from being approved unanimously even if FDA authorisation aroused the enthusiasm of some researchers. With the first authorisation, Pr Marc Peschanski, director of I-Stem laboratory, was delighted: “The lines of hESC [human embryonic stem] oligodendrocyte cells prepared for performing this trial will be at team’s disposal to conduct other trials which will save significant time. We are discussing this theme for a long time with this group and we know that these researchers are open and ready to exchange”. Others are more prudent. Dr David Prentice, former professor of biology at the Indiana State University, is worried: “Even a certain number of scientists in favour of embryonic stem cells expressed reservations about Geron’s trial, which did not prove themselves, even on rats. The preoccupation, for most of us, is that Geron puts patient health and life in danger, only to mark a political point and increase share prices.“
Indeed, it is not the first time that Geron benefits from this type of announcement. In 2004, it has already affirmed it wanted to conduct clinical trials with glial cells coming from embryonic stem cells for repairing lesions of the spinal cord. It had started again the announcement in 2005. These announcements always go together with the increase of its stock exchange quotation.