Madrid, July 2005 - Cellerix, a company belonging to the Genetrix group and specialised in the
development of cell-based therapies, has received Orphan Status designation by the European
Medicines Evaluation Agency (EMEA) for one of its products in development. Cellerix’s
medicinal product is currently in clinical trials and uses stem cells taken from adipose tissue
coming from the same patient, and will be used for the treatment of fistulas.
Cellerix was founded in 2004 with the objective of exploring the therapeutic potential offered by
the latest developments related to the use of adult stem cells for the regeneration and repair of
The company has the first, and only GMP certified installation in Spain for the production of cellbased
medicines. For Cristina Garmendia, Chairman of the Genetrix Group, this is of key
importance: "we are the only lab in Spain authorised by the EMEA to undertake this kind of
development." In addition to the indication for which Cellerix has gained Orphan Status, "the
company is exploring products for the regeneration of soft tissue, biomaterials as support
matrices, and their equivalents for skin," added Garmendia.
The product from the Spanish Biotechnology company Cellerix has demonstrated both safety
and efficacy in phase I clinical trials and is currently in a phase II trial with a larger number of
patients. For Jorge Alemany, Chief Executive Officer of Cellerix, "with this milestone the
company positions itself a European reference in the emerging sector of cell-based therapy,
and has been able to convert a field which has, until now, been considered as pure research,
into a therapeutic reality."
The technique developed by Cellerix is based on the use of stem cells taken from adipose
tissue coming from the same patient. Using a simple liposuction, the required quantity of fat is
extracted to isolate the stem cells which are then multiplied in the labs of Genetrix. The cells
processed in this manner are subsequently applied to the site of the fistula and the patient may
be cured within a few weeks of treatment.
Dr. Damián Garcia-Olmo, Director of the Cell Therapy Unit at the Hospital La Paz in Madrid
explains, "this approach is particularly attractive since it offers much higher yields for obtaining
adult stem cells than from using other sources, for example, such as bone marrow, and is easy
to perform by way of a simple liposuction. An important advantage of this method is that the
implant is performed using cells coming from the same patient, eliminating any problems
associated with rejection, often typical of transplants from different donors."
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Orphan status designation is awarded to those medicinal products that are for preventing or
treating life-threatening or very serious conditions that are rare. Up until July 200, only 284
medicinal products have received Orphan status by the EMEA, and up until now, none of those
have been for a cell-based medicinal therapy.
This designation allows Cellerix to benefit from the incentives provided to these types of
medicinal products, which amongst others, includes market exclusivity for 10 years, fee
reductions, and access to EU-funded research as well as promoting a faster time to market.
Cell-based medicinal products
In the different tissues that make up the human body, so called stem cells can be found which
are capable of transforming themselves into any type of human tissue. At present, it is possible
to isolate and multiply these cells for subsequent transplantation into the body in places where
tissue regeneration is needed. It allows for cells to be used as authentic living medicines,
paving the way for new therapeutic applications, impossible up until now.
Treatment of fistulas
Anal fistulas are abnormal connections between the anus and the rectum, with other epithelia
(skin, vagina....), which under normal circumstance should not be connected together. It is a
pathology that seriously affects the quality of life of sufferers given that in many cases, anal
incontinence develops and leads to a high risk of infections Surgery is the only current
treatment, which is both expensive and shows poor efficacy, particularly in fistulas arising from
other pathologies, such as in Crohn’s disease.
Cellerix is a Spanish Biotechnology company founded in 2004 with the objective of exploring the
therapeutic potential offered by the latest developments related to the use of adult stem cells for
the regeneration and repair of tissues.
For more information, please contact
Vicente Díaz Martínez, Communication (Genetrix)
Tel. +34 (91) 804 92 64 ext. 209