Yeah I think I'd be waiting for the detailed data on this one rather than just Top line headline..., the Phase two data was quite selective...
Not saying it doesn't have any scope...there were a larger number of drop outs during their earlier studies...
Check out this article:
https://regenexx.com/blog/new-research-on-amniotic-injections-renu/
(if above link doesn't work try searching for this):
---------------------New Research On Amniotic Injections: ReNu
-----------------------
"In the ReNu group, the company lost 15% by the end of the study, which is a bit high for an RCT, but still within the acceptable range. However, in the HA group, they lost 75% of the subjects! It was the same in the saline group where they also lost 75%! Those are in the very much “unacceptable” range for an RCT. Meaning you have a total of 109 subjects in a 200 patient trial where you have missing data. That’s more akin to a registry-based case series than an RCT". 1
...and also this statement:
"While these results demonstrated improved patient responses to ASA, dropout from the study and uneven groups pose significant challenges in data analysis.".2
In their phase 2 there were fairly good pain reduction results against HA arm. There were no indications of structural improvements:
There were no statistical differences in baseline radiologic parameters, including KL grade (P = .6202), worst compartment (P = .2863), and joint space narrowing (P = .3065) between treatment groups. The medial compartment demonstrated the highest proportions of worst compartment assessments across all treatment groups: ASA (64.7%), HA (65.6%), and saline (73.5%). Radiographs showed no significant changes between treatment groups with absolute joint space narrowing at 12 months (P = .9031) or change in joint space narrowing from baseline (P = .9297).
Renu is administered intra-articularly
DYOR
Ref:
1) https://regenexx.com/blog/new-research-on-amniotic-injections-renu/
2) https://sciencedirect.com/science/article/pii/S0749806321002218
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