If you dive a little deeper into this Temcell study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8417106/#B11
You can see a few interesting things occuring regarding Remestemcel and TEMCEL
- It used the old manufacturing technique.
- It used the old potency assay values.
- The cells had less ( almost half ) the TNFR-1 count.
- The cells had almost hall the T-cell suppression levels.
- JCR's cells had about the same OR as Mesoblasts did.
Since that now 17year old data, a lot has changed in the company
- The manufacturing process increased the potency of the cells
- The potency assay minimum potency levels were revised
- There was a new trial conducted using 100% the new cells, with the higher potency, and as expected it yielded much better results. How much better? Significantly better than all other trials.
- When previous treated patients that were selected post hoc from older MSB trials, where the cells had the same release criterea as they now do, the results were the same.
79% survival at 100 days ** New remestemcel - protocol 280
74% survival at 100 days ** New Remestemcel
66% survival at 100 days Old Remestemcel
51% survival at 100 days Old remestemcel
27 % survival at 100 days Temcel
34% survival at 180 days Old remestemcel
42% survival at 180 days Other
33% survival at 1 year Ruxolitinib ( approved )
49% survival at 1 year Unspecified MSC
27% survival at 1 year Thymoglobulin
63% survival at 1 year ** New remestemcel
40% survival at 1 years - Mcmillen et all
25% survival at 2 years - Rashidi et al
44% survival BAT at 1 year - Reach2
49% survival at 1 year Ruxolitinib ( approved )
43% survival at 1 year Ruxolitinib ( approved )
25% survival at 2 years - Rashidi et al
51% survival at 2 years - **New Remestemcel
49% survival at 4 years -** New Remestemcel
So , not a single study has more than 50% survival, except those using Remestemcel-L.
Hmmmmmm........ Looks like there is proof after all !
You could say the comparisons with Temcel are to say the least old product v old product pre product improvement. Even then JCR manage 40% market penetration. Has JCR implemented improvements to their own cell manufactuirng and potency assay? They have not told anyone if they have. 17 year old comparisons of efficacy now are really in the realms of science fiction, making massive unproven assumptions along the way.
Meanwhile, MSB went back and confirmed the same high level of survival when using the current updated release criterea.
The proof is in the pudding.
Case closed.
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