Will EU Be First to Approve Off-The-Shelf Stem Cell Treatment?

Even as the U.S. FDA is moving to more heavily regulate stem cell therapies in this country, the European Union (EU) has just taken the next step in approving an off-the-shelf stem cell therapy for treating a complication of Crohn’s disease. If they do approve the treatment offered by a Belgian biotech company, it will be the first such approval of its kind. It could likely pave the way for similar approval here in the U.S.

Alofisel is a revolutionary treatment utilizing allogeneic stem cell transplants to treat troublesome perianal fistulas in patients with Crohn’s disease. The treatment was just given the green light by the EU’s Committee for Medicinal Products for Human Use. It is expected that the EU will give its final approval in short order, barring any unexpected complications.

The Challenge of Crohn’s Disease

Crohn’s disease is a chronic condition characterized by significant, long-term inflammation of the digestive tract. People suffering from the disease experience regular pain and diarrhea along with bloody stools. Some patients exhibit significant weight loss as well. In the long term, digestive tract inflammation can lead to the development of perianal fistulas, unnatural openings that lead from the bowels to the skin surrounding the anus.

These fistulas are especially dangerous because they can lead to both incontinence and sepsis. Sepsis is a serious condition that can be life-threatening in some circumstances. It is definitely something you don’t want to mess around with.

The proposed off-the-shelf treatment utilizes allogeneic stem cells to reduce inflammation so that fistulas can be dealt with by the body’s natural healing mechanisms. The stem cells also regulate immunological activity at the same time. The key to success is getting the stem cells to the right location and activating them the right way.

Allogeneic Stem Cells Explained

The most interesting aspect of the proposed treatment is the source of the stem cells in question. Where autologous stem cells are taken directly from the patient being treated, allogeneic stem cells come from a separate donor. These are stem cells capable of forming blood, taken from someone who is genetically similar to the patient being treated. In most cases, the donor is a sibling. It is not necessary for a donor to be genetically related, though.

Allogeneic stem cells are already used for the treatment of leukemia, aplastic anemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma. In patients whose own autologous stem cells are either not available or not workable, doctors will use allogeneic stem cells instead.

In the case of the European treatment for Crohn’s disease, approval of allogeneic stem cells would indicate an off-the-shelf solution for any patient whose Crohn’s disease has resulted in dangerous fistulas. This is a game-changer, to say the least. Doctors would only need to establish a genetic similarity to get the material they need to treat a given patient. Eventually, approval could make stem cell treatment rather routine.

Stem Cell Treatment Moving Forward

In Murray, Utah, doctors attend stem cell training courses conducted by a company known as Apex Biologix. The procedures they learn rely on autologous stem cells for treating orthopedic injuries, hair loss, and other conditions. Perhaps one day those same doctors will be learning procedures utilizing allogeneic stem cells injected to treat the fistulas common to Crohn’s disease.

The good news is that stem cell treatments are moving forward after decades of receiving very little attention. The more we learn about these amazing cells and their ability to promote natural healing, the more we understand how valuable they could eventually be in transforming modern medicine.

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