The Spanish Agency of Medicines (AEMPS) has authorized the Cell Therapy Unit of the Regional Hospital of Malaga-Ibima, dependent on the Andalusian Initiative in Advanced Therapies, to manufacture allogenic mesenchymal stem cells (donor) for research patients participating in clinical trials, or for those who, not meeting any of the criteria for inclusion in the trial, could benefit from treatment under compassionate use. Thanks to this, cell therapy drugs will be developed from donor fat for different types of patients that do not respond adequately to established treatments or for patients with diseases that lack treatment.
This will benefit patients with neurological diseases such as Acute Cerebral Infarction, Amyotrophic Lateral Sclerosis or Multiple Sclerosis, patients with fecal incontinence who do not respond to other treatments or other diseases, especially autoimmune, which currently have no treatment. The technical director of the Cell Therapy Unit of the health center, Laura Leyva, says that there are previous studies that have shown efficacy of cell therapy in some of these diseases, and in other cases their effectiveness will be studied through the realization of new clinical trials
Prior to receiving this authorization, this unit was authorized exclusively to manufacture autologous adipose tissue mesenchymal cells, that is, from the patient himself. For this, it was necessary to extract adipose tissue to each of the patients who were going to be treated in a clinical trial of Cell Therapy in order to obtain their mesenchymal cells and expand them, for subsequent infusion. With the new authorization of the Spanish Medicines Agency, the treatment is faster because the cells are obtained from the fat of a healthy donor and the yield is higher, since from the fat of a single donor tens can be treated of patients.
"At a technical level, with a more or less similar investment of resources, you get many more doses and treat many more patients," explains Laura Leyva, who says that donations will be obtained thanks to the collaboration of the Autonomous Transplant Coordination and the Biobank of the Public Health System of Andalusia.
The professionals have calculated that each donor will be able to extract between 200 and 500 grams of adipose tissue from the abdominal wall. "It is positive because it is going to treat a greater number of patients than with autologous or own cells, thus giving a faster response to the patient that avoids undergoing surgery," explains Laura Leyva.
Once the extraction is done to the donor, the adipose tissue is digested enzymatically and the stromal vascular fraction is obtained, formed by mesenchymal stem cells of the fat and by a mixture of blood cells among which are lymphocytes, monocytes, red blood cells and some fibroblast. "These cells are sown in culture flasks and, after about 24-48 hours, the culture medium is aspirated so that most of the blood cells are removed, leaving only the cells adhered to the plastic of the culture bottle, which are mostly mesenchymal cells, these cells multiply in the culture bottles over several weeks and, in the end, we have a practically pure culture of 99% mesenchymal cells, "explains the technical director of the Cell Therapy Unit.
When this process is concluded, the professionals working in the so-called 'White Room' perform various quality controls to provide sufficient guarantees that the cells are safe for the patient and can be infused without any risk of transmission of infections or genetic alterations.
This type of drugs of allogeneic cell therapy may be used in clinical trials (as in the European project in which the Cell Production Unit of the Regional University Hospital of Malaga for the treatment of acute cerebral infarction) or for compassionate use in diseases where there are sufficient indications of its beneficial effect as some autoimmune diseases, in the neurological diseases mentioned previously or fecal incontinence.
Source: University Regional Hospital of Malaga