“Latest Stem Cells News”

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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.

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Hebrew University of Jerusalem

Researchers at the Hebrew University of Jerusalem discovered a method to potentially eliminate the tumor-risk factor in utilizing human embryonic stem cells, said the university on Wednesday.
The researchers’ work paves the way for further progress in the promising field of stem cell therapy, said the press release of the university sent to Xinhua.

According to the release, human embryonic stem cells are theoretically capable of differentiation to all cells of the mature human body (and are hence defined as “pluripotent“).
This ability, along with the ability to remain undifferentiated indefinitely in culture, make regenerative medicine using human embryonic stem cells a potentially unprecedented tool for the treatment of various diseases, including diabetes, Parkinson’s disease and heart failure.

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Spinal cord injuries, resulting in permanent disability or paralysis in most cases, account for around eleven thousand new cases in the US, annually. Due to the lack of effective treatment strategies, it is considered as the most devastating of all traumatic conditions. Now, a recent study published in the journal Stem Cells reports that activation of ependymal stem/progenitor cells from injured spinal cord (epSPCi), using endogenous stem cell-associated mechanisms, may aid in rescuing neurological function, thereby reversing paralysis associated with spinal cord injuries.

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At the San Timoteo Hospital in Termoli-Larino (Molise, a small region in south central Italy, formerly part of the region “Abruzzi e Molise”) everything is ready for stem cells gathering - in conjunction with the orthopedy ward (branch of medicine dealing with diseases of the bones and joints) – which will be used for local treatments, above all on pseudo-arthrosis.

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Reviewing the technology, business models, intellectual property, regulatory concerns, transplantation and immune rejection.

from http://biobusiness.tv/videos/202

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