I wasn’t aware about this trial but apparently TiGenix announced that it was enrolling patients in a Phase III clinical trial for patients with perianal fistulas for Crohn’s. The treatment is a stem cell therapy with the patient using fat tissue from stem cells that is then injected into the fistula via injection. The trial should have about 200 Crohn’s patients who all have complex perianal fistuals. The trial took place ahead of schedule (results expected in 2014) which is good news.
According to this press release from the company that had 24 patients enrolled with 2 that had to be withdrawn from the study but it could have been due to Crohn’s itself and not the disease. More than 56% of patients had their external fistula orifice close. Also according to this presentation was more than twice as effective as Remicade (56% compared to 23% for Remicade)
It would be interesting to see how this medicine would work for just regular Crohn’s patients. As I have mentioned before on this blog it takes many years to get a drug approved. The drug was given orphan status (meaning since the disease affects so few people it was expedited in clinical trials) yet I have no idea when this drug will be approved if ever in the United States. Once a drug is approved by a foreign country it should automatically be approved in the United States so the people that are suffering can benefit.