Biomedical Engineering Reference
In-Depth Information
embryonic stem cells, the outcome was highly anticipated, and the
decision to discontinue the trial for financial reasons has been a blow
for the commercial future of hESC-based therapuetics. However, Geron
have stated that they are looking for partners to continue developing
their novel therapeutics, so this situation may change in the future.
5.2.2 OtherFDA-approvedclinicaltrials:AdvancedCellTechnology
Another US-based company, Advanced Cell Technology (ACT)
(
http://www.advancedcell.com
), has obtained FDA approval to
conduct two clinical trials on hESC-derived products. The ACT
clinical trials are for conditions causing macular degeneration and
are only the second of any FDA approvals for clinical trials involving
hESCs in the US. ACT's therapeutic approach requires using
hESC-derived retinal pigment epithelial cells that regenerate retinal
pigment epithelium and thus restore photoreceptor function which
is dependent on it. A key feature of the ACT technique, too, is that
they have patented the use of a single blastomere taken from an
early-stage embryo in a process similar to that used in pre-implantation
genetic diagnosis.
ACT is a small biotechnology company dedicated to cellular
therapy development. In addition to the hESC trials now underway,
they have a trial using autologous adult stem cells for a range of
heart indications about to begin Phase II testing in the US. They are
also in the process of developing hESC-derived hermangioblasts for
clinical treatment of blood and cardiovascular disorders with
collaborators in Korea. In the 'Company Fact Sheet' available on the
ACT website, the company claim to have over 150 patents and
patent applications underway (
http://www.advancedcell.com
). Two
patents cover the derivation method of stem cells from a blastocyst
that does not destroy the embryo, and a third patent applies
specifically to their derivation technique for retinal epithelial cells.
The ACT patents will ensure market protection for a number of
years should the current clinical trials prove successful.
Retinal pigment epithelium (RPE) cells were first reportedly
derived from hESCs in 2004 (Klimanskaya et al., 2004). This study
