Originally posted by batman12
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1. All the patients (except for a single one) treated in the phase I clinical trials were advanced (non-ambulatory) progressive patients between EDSS 6.0 and 8.0. It is now known today that this subset of the MS population responds "least-favorably" to HSCT treatment. In fact, this is why all the phase II and phase III trials automatically exclude all progressive patients and only treat people that are episodic. The main lesson learned from the phase I trials is to treat people earlier in their disease cycle, as opposed to later. (Or in the case of progressive patients, the lower the EDSS score, the better.)
2. The phase I clinical trial(s) of ten years ago all incorporated Total Body Irradiation (TBI) as part of the treatment protocol. Complications associated with TBI conditioning accounted for the deaths (and perhaps further stress-related neurologic deterioration) of the treated-patients in this early work. The evolved protocol today no longer uses TBI, having been determined to add substantial treatment risk with no added curative benefit. All the current HSCT treatments (for MS) have now omitted the unnessesarily risky TBI without sacrificing curative efficacy. (The cellular antigen epitope can be rendered naive without use of TBI. Gentler chemotheraputic agents alone can accomplish this.) In the phase II (and now phase III) trials, there have been zero deaths. None anywhere.
3. The phase II trial (without TBI) started in 2003. So now we're into the 8th year following this evolved protocol and not a single patient has progressed (as measured by EDSS). Not a single one. Very strong indication that HSCT has long lasting curative results. Perhaps even lifelong. Time will give us the final answer on this.
As part of my treatment I did not receive TBI, nor was is necessary for me to have received it. Also, as opposed to the phase I trial patients, I was 100% ambulatory and I was not PPMS. So this current HSCT treatment cannot be directly compared with the earlier treatment.
So I still stand behind the original data comment. Essentially 100% of RRMS patients do have their underlying MS disease progression stopped. I have not seen any data to suggest otherwise.
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