Continuing on the "lack of proper control", which was also mentioned. Not sure I completely agree.
To begin with, why MSCs?
2016 (I recommend sci hub)
https://pubmed.ncbi.nlm.nih.gov/27755168/It also dives into the reasoning behind the next step, the Secondary Objective of The Nereid Study - the development of "de novo donor specific antibodies" (
https://onderzoekmetmensen.nl/en/trial/53310).
With the Triton Study (
https://clinicaltrials.gov/study/NCT02057965) forming the "backbone" (
https://onderzoekmetmensen.nl/en/trial/53310) of our Nereid Study, we should perhaps also have a closer look at the design and conclusions drawn.
The Triton Study recruited a total of 29 patients (final number) that
didin't receive the active ingredient (MSCs):
interesting:
The Triton Study used alemtuzumab, The Nereid study is now using basiliximab. Why?
"[...] which was chosen as we anticipated a higher immunological risk due to the early CNI withdrawal."
However, alemtuzumab could not be ruled out for failing the trial's Primary Endpoint:
"In our study, fibrosis scores were similar in both the MSC group and the controls, thereby failing to meet the primary end point, and the incidence of acute rejection 24 weeks after implantation was low. One explanation might be the use of alemtuzumab, [...]."
Final paragraph of the "Discussion":
"At present, randomized trials with MSCs are still very limited and the field is only slowly advancing also due to stringent regulatory requirements, the need for clinical grade cell production facilities, and the associated costs. However, we recently also reported the feasibility of administration of third-party “off-the-shelf” MSCs in kidney transplant recipients.11 This option makes manufacturing and regulation easier and the use of MSC suitable for a wider spectrum of clinical application and much more feasible. We believe that the results of our current trial set the stage for the next steps and use of MSCs in the field of kidney transplantation to reduce the need for excessive use of clinical immunosuppressants."
https://www.amjtransplant.org/article/S1600-6135(22)08714-7/fulltextAs mentioned in my previous post, results were assessed and used in the development of the protocol for the next trial and/or results were compared. They have the means to establish a comparison that is good enough for a PI/IIa trial it seems.
Disclaimer:
Since both are measuring the same... output..., please ensure to thoroughly study my latest colonoscopy report and my Tiprank score before drawing any conclusions using the above post:
https://www.tipranks.com/experts/bloggers/pfeifer1982
(20min delay)