Clinical

clinicalThere are nowadays many diseases for which there is still no effective treatment. In the case of certain of these, we are making some advances in the research to find a treatment using advanced therapy medicinal products (cell therapy, tissue engineering and gene therapy). The Andalusian Initiative for Advanced Therapies has, as one of its main objectives, to facilitate access to those therapies to the Andalusian population on an equitable basis whilst guaranteeing their administration under the strictest legal requirements and the highest safety.

In this regard, the work of the Andalusian Initiative for Advanced Therapies ranges from manufacturing advanced therapy products considered in most cases as medicinal products, to setting up and monitoring a range of clinical trials in phase I/II and III, to show their safety and efficacy and subsequently to incorporate these therapies into routine clinical practice in the near future.

The Coordination Unit of the Andalusian Initiative for Advanced Therapies promotes clinical trials in different therapeutic areas involving researchers belonging to the Andalusian Public Health System as well as to other Regional Communities.

CLINICAL TRIALS

clinical trialsWith the patients’ benefit as our main concern, the Coordination Unit of the Andalusian Initiative for Advanced Therapies sponsors clinical trials which might bring about new evidence in important areas of healthcare as well as improve the quality of life of patients and their families.

Thanks to the collaboration and commitment of our researchers we can claim that we are leaders in the field of Advanced Therapy clinical research in Spain. At present, the Coordination Unit of the Andalusian Initiative for Advanced Therapies manages 24 clinical trials with advanced therapy medicinal products in which several hundred of patients have participated. These trials are being developed in various centres belonging to the Andalusian Public Health System as well as to other Regional Communities. Over 10 products in different therapeutic areas, such as cardiology, haematology, neurology and immunology amongst others, are being trialled.

GMP LABORATORIES

gmpIn general, advanced therapy products derive from cells or tissues coming either from the patient himself (known as autologous) or from other donors (allogeneic). These products are for the most part considered as medicinal products and, therefore, their manufacture must be carried out in pharmaceutical laboratories under strict quality and safety conditions, i.e., under GMP conditions (Good Manufacturing Practice). To manufacture these medicinal products, the Andalusian Initiative for Advanced Therapies synchronizes a network of GMP laboratories and processing centres distributed throughout Andalusia. Each of these specialises in the manufacturing of one or more of these advanced therapy medicinal products.

The ways through which access to these therapies is facilitated are as follows:

1. Clinical trials promoted by the Andalusian Initiative for Advanced Therapies.
2. Compassionate use of medicinal products in research.

CLINICAL TRIAL PROPOSAL

In the Andalusian Initiative for Advanced Therapies we are particularly interested in collaborating in translational research projects from researchers belonging either to the Andalusian Public Health System or other national or international regions. Consequently, should you have any clinical trial proposal, please, send us an e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it. providing a summary of the project, its justification and kind of product.

Once your proposal has been assessed by the Clinical Research Technical Committee in the Andalusian Initiative for Advanced Therapies, we will contact you.

 

 

 
investigadores


"What I probably admire the most of Andalusian Initiative for Advanced Therapies is that it does not matter whether the solution to a genetic disorder or a traumatic injury is developed first in Andalucia or in India, or USA. What it matters to them is that it should be implemented in Andalucia, by Andalucian Scientists and Physicians, with no delays.

There is an incredible level of dedication in all members of Team, a contagious energy spirit headed by its director. As a consequence, this incredible talented group of scientists, administrators, and health care workers, are immune to those unwilling to recognize that new therapies for untreatable conditions can indeed be developed in Andalucian soil."

Prof Jose Cibelli
Professor of Animal Biotechnology
Head of Cellular Reprogramming Laboratory
Michigan State University, USA
Scientific Director -LARCel – Seville, SPAIN