#clinical trial

At eight UK sites, 20 million allogeneic neural stem cells (CTX0E03) were injected into the putamen of 23 stroke patients by stereotactic neurosurgery. The primary endpoint was not met, the randomized trial meant to confirm the findings stopped at 15 patients, and the developer went through administration and delisted. Here is what a single-arm study can and cannot say, read straight from the numbers.

An average of 22 months after stroke, paralysis that should no longer move. A phase 1/2a trial implanting genetically modified allogeneic bone marrow MSCs (SB623) around the infarct met its primary endpoint in 18 patients over two years. But there is no control group. Two months later the phase 2b ACTIsSIMA, sham-controlled in 163 patients, missed its primary endpoint (p = 0.6743). The same cells reached approval not in stroke but in the parallel traumatic brain injury trial.

ALMB-0166, the first Cx43-hemichannel antibody, given as a single dose to 24 SCI patients: adverse events matched placebo, 1200/2400mg improved scores, two reached AIS E. A small, exploratory result.