The Institute of peace research leads another trial with stem cells from fat.
is the first funded by the Ministry of health.
Madrid, 2013-February the Institute research health of the La Paz University Hospital began the coordination of a new phase III clinical trial with stem cells from fat involving 80 patients from five Spanish hospitals. It is the first time that a phase III trial is not financed through the industry but with public money, in this case, from the Ministry of health, social services and equality.
The new trial is promoted by IdiPAZ, the Institute of research health of the La Paz University Hospital, and is framed online therapy cell TerCel, of the Instituto de Salud Carlos III. It has a funding of about 600,000 euros and hospital General de Valencia, Clinico Universitario Lozano Blesa de Zaragoza, University Clinic of Navarra and social welfare complex of Salamanca also participate. Its objective is to test the effectiveness of stem cells autologous (from the patient’s own) in the treatment of fistulas in patients who do not suffer from Crohn’s disease.
Routine clinic
The study will be done on a total of 80 patients. In the group control, 40 patients, fibrin glue will be used and in the remaining 40 used glue of fibrin as well as stem cells cultivated from the patient. This is the last test carried out for this experimental line started in 2002 at the La Paz Hospital. When concluded, within a year, the technique will leave be considered research to become part of the clinical routine.
In this trial, as in the previous ones, is a liposuction of 100 cubic centimeters of subdermal fat from the patient, isolating and cultivating the cells in the laboratory. Extraction, performed by plastic surgeons, is performed with local anesthesia through an incision less than a cm that is inserted a cannula. Se realiza fistulous pathology surgical intervention following the usual procedure, but they are also injected in different points of the fistulous between 100 and 200 million stem cells from the patient already cultivated.
from left to right: Olga Lopez (ClÃnico Salamanca), Enrique Andreu (CUNavarra), Jacinto Garcia (ClÃnico Salamanca), J GarcÃa Armengol (General Valencia), Damian GarcÃa Olmo (peace), j. Baixauli (CU Navarra), Mariano GarcÃa (IdiPAZ), José Gracia (Lozano Blesa Zaragoza), Hector Guadalajara (La Paz).
the phase I trial began in 2002 with 5 patients and in it was documented for the first time in the world the success of using stem cells from the patient’s own fat. A phase II trial were subsequently conducted to determine the effectiveness of the drug, and from 2007 conducted several phase III in order to demonstrate and confirm the results. They involved more than 300 patients from 40 European hospitals with and without Crohn’s disease.
Crohn’s disease is a chronic inflammatory process of unknown origin that affects the bowel at all its stages. Fistulous pathology is one of its characteristics and is one of the problems that most reduces the quality of life of these patients. Each year around 2,000 new cases are diagnosed in Spain and it affects both men and women of any age, although it tends to manifest itself for the first time between 15 and 30 years.
