“Latest Stem Cells News”

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.

According to a recent article in Lancet magazine, the first “engineered” transplant in the world was a success. For the first time, a trachea was “tailored” to the patient before being implanted. 30 year old Colombian Claudia Castillo who suffered damage to her trachea due to tuberculosis was the patient in an operation that was particularly interesting for Italy, since the operation was performed in June by an international medical team led by Paolo Macchiarini, the head of Thoracic Surgery at the Clinic de Barcelona, in collaboration with specialists from the Milan General Hospital, and the Universities of Bristol and .

During the transplant, her own stem cells were implanted into the donor trachea in order to avoid using traditional anti-rejection therapy based on immunosuppressant drugs. In order to allow the patient’s immune system to accept the trachea without having to use anti-rejection therapies, doctors resorted to a tissue engineering technique. The result was a sort of hybrid organ between the donor and the patient. Basically, the donor’s organ was used, but it was cleaned of its own cells which were then substituted with stem cells from the patient. This allowed doctors to perform the transplant without using immunosuppressants. The therapy used was only tested on pigs and is still in its experimental phases.

An experimental treatment in Spain has shown promising possibilities to rebuild breasts damaged by tumors with the use of fat taken from the patient’s abdomen, removing stem cells, then injecting them into the chest, in a process that takes from four to five hours and does not leave scars.
Five patients from Madrid were the first in Spain to undergo the pioneering operation performed at Gregorio Maranon in collaboration with three other European hospitals in Great Britain, Italy, and Belgium. Mesenchymal stem cells, adult stem cells with the ability to transform into different tissues, are the key in this process. If the technique functions, something that will be able to be assessed in a year, it will mean that the cells have generated new blood vessels to heal the area.

The candidates were all recovering from a tumor called T1 No Mo. These are very small tumors that have not metastasized to the ganglion or anywhere else. The conditions to participate in the experiment were very strict in order to avoid complications feared by stem cell researchers, since stem cells have a great reproductive capacity and could cause cancer. “In this case, the stem cells are separated, but not stimulated. The women will also undergo ultrasounds in Lyon”, explained plastic surgeon, Jose’ Maria Lasso.