Thanks
@MJC73 for the link ....
https://www.gastroenterologyandhepa...-of-fistulas-in-patients-with-crohns-disease/Some interesting comments by Amy Lightner MD in this report ... she refers to a number of different stem cell trials in the Fistula and Crohn's area as well
.... some studies she refers to show healing out to as long as 1 year and another smaller trial
shows healing out to a whopping 4 years !Certainly impressive data.... I am sure Mesoblast can capitalise on this treatment down the track but there are obviously larger indications on the radar at present that need to be dealt with.
GLTAH
G&H What clinical trial data have been reported on stem cell therapy for fistulas in patients with Crohn’s disease?
AL There is an increasing number of clinical trials in this area, and more and more data are showing that this approach is safe. No significant adverse events have been reported with stem cell therapy or the direct injection of stem cells.
Additionally, there is no risk of incontinence, and the efficacy of this approach is quite high. Most recently, a phase 3 clinical trial was completed with nearly 300 patients that showed a significant benefit with stem cell therapy compared with placebo.
Healing rates were greater than 50% with stem cell therapy compared with approximately 33% in the placebo group. Healing is thought to be related to the anti-inflammatory and immunomodulatory benefits of stem cell therapy.
G&H Have clinical trials looked at different stem cell doses, sources, and modes of delivery?
AL Different doses have not been compared or studied to date in large clinical trials.
Sources of stem cells used in trials have been either bone marrow or fat tissue, but trials have not directly compared outcomes from the 2 sources. Modes of stem cell delivery have been limited to direct injection or placement on a plug. Stem cells placed on a plug were studied only in one trial of 20 patients to date. The other trials have all included direct injection of stem cells by the internal opening of the fistula tract and around the external opening parallel to the tract.
G&H How long do the effects of stem cell therapy appear to last?
AL The largest and only phase 3 study that has been conducted to date goes out to 1 year. In this study, patients who had healed at 6 months were still healed at 1 year.Smaller studies have reported that healing is sustained out to 4 years. Thus, it appears that the effects of stem cell therapy are long-lasting and that healing rates are durable.
G&H What is the risk of fistula recurrence, and how can this risk be reduced?
AL The risk of recurrence is very high; fistulas will recur in two-thirds of patients. The best way to reduce recurrence is to maintain good disease control in the rectum and prevent inflammation from developing there. This is most often done by being on maintenance medical therapy, usually with biologics.
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