Culturing stem cells to use to treat certain illnesses is already a reality. In Spain, two labs have received authorization from the Agencia Espanola de Medicamento y Productos Sanitarios to produce stem cells, and there are others waiting to be certified.
Currently, just one public health center, the Gregorio Maranon Hospital in Madrid (HGM) and one private center, the Clinica Universitaria in Navarra (CUN) have undergone the rigid system of quality certification to become “Good Manufacturing Regulations” (GMR) laboratories and are developing stem cell products to be administered and transplanted into patients.
Cardiology, urology, hematology, oncology, and dermatology are some of the areas that will benefit from this research. Manufacturing cells for treatment is extremely rare and there is currently no commercial development in this area. The cells are basically used in small “wise, independent clinics” on a few subjects.
There are two cellular production processes based on how the cells are manipulated: the first method extracts stem cells, selects them, and purifies them for a future transplant into a patient; the other, which requires greater manipulation and infrastructure with a GMP quality system for cellular production to use the products to treat sick individuals.
Each manipulation that alters a cells basic characteristics cause it to be considered a medicinal product. Therefore, “the same regulations are applied that are required by the pharmaceutical industry to produce pharmaceuticals,” explained Javier Perez Calvo, the head of CUN’s GMP lab. The criterion that needs to be followed is complex and a clean room alone is not sufficient.
“The entire cell production process is subject to precise biological and cytogenic inspections to verify the safety of the samples in compliance with manufacturing regulations, guaranteeing that the patient is receiving cells that are cultivated and multiplied under optimal conditions,” explained Maria Eugenia Fernandez Santos, the head of the Gregorio Maranon unit. The cells come from the patient. The process involves “directing” the cells with enzymes or breaking down the tissue until, once the cells are obtained, the proper conditions of humidity, carbon dioxide, and temperature are supplied.
Then, the cells divide and multiply to obtain a sufficient number of stem cells to perform the treatment according to the needs of the specific clinical experiment and transplant strategy. The cells are made available to the researcher on the requested medium, syringe or sac, so they can be implanted into the patient.