- The Phase I/II study has been successfully completed on 38 patients with both conditions. This phase was to look at safety and dosing of the stem cells and has been reported to have no major risks or adverse events.
- The Phase II part of the study has been given the go ahead and will also be conducted in England as well as the United States.
- The next phase will once again be looking at the safety and also the efficacy (ie if it improves vision) against a control group (used as a comparison for change). The effects of immuno-suppressant drug use will also be evaluated.
What does this mean?
It seems as though the trial is going well - since it moving ahead we can assume that there have been no major reactions from patients receiving the injections and that some benefit is being observed. The next part of the trial will recruit a greater number of participants to further evaluate what impact stem cell implantation may have on vision. The researchers will also try to find the best way of implanting the cells for greatest benefit.
There's still a little way to go before we will know for sure whether this treatment will work, although it is definitely looking positive at this stage. Generally a therapeutic trial will pass through four phases, each recruiting an increased number of patients.
I shall keep following and continue to update everyone!
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