If Japan approves a voice cell treatment for spinal cord injuries in a landmark – if little noticed – decision, experts around the world have voiced concerns that undergo the trouble that still plague first-gen voice cell therapies.
the request of Nature News 10 specialists in voice cell science or spinal cord injuries poke holes in the small clinical trial that formed the basis of the conditional approval, questioning both the efficacy and safety of the treatment. ] The therapy, Stemirac, involves extracting mesenchymal stem cells from a person who suffered from a spinal cord injury, growing about 50 million to 200 million of them in a lab, then intravenously infusing the MSCs back into the patient within 40 days of the injury . Exactly how it works to repair damage to the spinal cord is a bit of a black box now: Researchers led by Professor Osamu Honmo at Sapporo Medical University believe it might have to do with reducing inflammation, protecting existing neurons or turning into nerve cells themselves. Their belief is based on an unpublished 1
Skeptics, however, remain alive
Without a double-blind trial design, there is no way to prove that Bruce Dobkin, a neurologist at the University of California, Los Angeles, told Nature News . 02] "This trial, as designed, does not reveal efficacy," said the claim that the MSCs converted to neurons in the trial is also a red flag.
Another reason to be cautious, according to to NIH stem cell researcher Pamela Robey: The fact, shown in previous research, that MSCs infused intravenously to get trapped in the lung "makes it difficult to see how they can be effective in the spinal cord."
Masanori Fukushima, The government-funded adviser to the project has stood by Honmo's work, emphasizing that some patients in the trial were too severely injured to have had natural healing.
When the medical equipment manufacturer Nipro Corp starts selling Stemirac, it can market some long awaited activity for regenerative medicine in the marketplace after years of delays and disappointments. But it's not necessarily the entry that the industry – which is now exploring next-gen, often off-the-shelf, voice cell-based therapies for diabetes, Crohn's disease and graft versus host disease among others – has been looking for.