Breathless miracle treatment coverage! Walk, talk, have a baby, win the Olympic decathalon – all despite having severe stroke! All it takes is a “simple procedure”!
The lay coverage reads like clickbait. In contrast – at least – the published abstract Results section leads off with “All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event.”
So, not quite such exaggerated hyperbole.
This is the PISCES II trial, implantation of modified bone marrow–derived mesenchymal stem cells directly into the brain. Cells were implanted via craniostomy, and five 20 μL cell deposits were made at 5 to 6 mm intervals along each of three cannula tracks into the peri-infarct area. 18 patients were enrolled after 379 were screened, and three differing dose concentrations of stem cells were used. The baseline NIHSS of the population had a mean of 9.44, and patients were all mRS 3 or 4.
With regards to that aforementioned “treatment-emergent adverse event”, thankfully, the vast majority were headache related to the procedure, along with nausea and vomiting. A few patients developed muscle spasticity, and among relevant serious adverse events, one patient had a seizure and one an asymptomatic subdural/hygroma. NIHSS improved by 2.00 points among the 16 patients available for 12 month follow-up, and there were other motor improvements and global functional improvements measured on the Fugl-Meyer score. MRI changes seemed to correlate with improvements in functional status, as well.
Literally every aspect of this trial was controlled by SanBio Inc., the purveyors of this recovery technology. The manuscript was ghostwritten by professionals funded by SanBio, and SanBio funded almost everything. Several authors are full-time employees of SanBio, and other authors are former employees and/or stockholders. It is nice to think this might offer promise and hope for stroke survivors, but this small trial is far from the breathless coverage provided.
“Clinical Outcomes of Transplanted Modifed Bone Marrow–Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study”