There is a detail that they never told you about spinal cord injuries: for decades we knew how to repair them, but we didn't have the right tools. Today those tools are here. They are called induced pluripotent stem cells e have just been approved for the world's first clinical trial aimed at completely regenerating damaged spinal cords.
This is not, mind you, about marginal improvements or palliative therapies. I'll put it simply: we're talking about regrowing dead nervous tissue. We're talking about restoring movement to those who have lost it forever.
A turning point that comes from where (perhaps) you don't expect it
The protagonist of this story is called XellSmart, a Chinese biotech that many will only discover today. Yet this week it achieved something extraordinary: the simultaneous approval by the American FDA and the Chinese authority NMPA to test on humans the first regenerative therapy in history against spinal cord injuries.
Allogeneic induced pluripotent stem cells developed by XellSmart work as a universal repair kit. No cells need to be taken from the patient, no invasive preparation procedures are needed. It is literally an “off-the-shelf” therapy that should work for anyone who has suffered a spinal injury.
Come we often underline, regenerative medicine is making great strides. But this time we are talking about something different: we are not repairing cartilage or simpler tissues. We are trying to regenerate the central nervous system.
How the Spinal Cord Repairs Itself
The spinal cord acts as an information highway between the brain and the body. When there is an “accident” on this highway, traffic comes to a complete standstill. Every year in the world, over 180 thousand new cases are recorded of spinal injuries, most due to road accidents, falls or sports injuries.
Until now, the therapeutic options were dramatically limited. Physical therapy, drugs to manage pain, assistive devices. But the damaged nerve tissue remained. How recent studies have shown, some experimental stem cell therapies have shown promising, but always partial, results.
The XellSmart treatment instead aims at complete regeneration. Pluripotent cells are injected into the site of the injury where they should differentiate into exactly the type of nervous tissue needed. They do more than just repair: recreate lost connections from scratch.
The Spinal Cord That Really Regenerates
XellSmart’s research builds on four years of preclinical studies that have shown that pluripotent stem cells can actually regenerate damaged spinal tissue. The mechanism is fascinating: once injected, these cells “read” their environment and automatically specialize in the type of neurons needed for that specific area of the spinal cord.
Mark Tuszynski and his team at the University of California have already demonstrated in the laboratory that it is possible to repair the corticospinal tract, the most important nervous circuit for the control of voluntary movements. results published in Nature Medicine represent an absolute first: Never before has it been possible to regenerate this type of neural connections so critical for movement.
The difference is that we now have “universal” cells that do not require genetic compatibility. Research by the University of Pisa and Yale They also identified that not all stem cells are the same: those with an anatomical origin similar to the recipient tissue prove to be much more effective in the regeneration process.
When can we say goodbye to wheelchairs?
The Phase I trial, conducted in partnership with the Third Affiliated Hospital of Sun Yat-sen University in China, is expected to be completed by 2026. If the results confirm the safety and preliminary efficacy, Phase II could begin in 2028.
Experts estimate that, if successful, The therapy could be commercially available within 5-7 years. A time that may seem long, but is relatively short for a technology of this type.
Other promising approaches are also emerging in the United States, where the Mayo Clinic has successfully tested stem cells derived from patients' fat on ten volunteers with traumatic injuries. Seven of them showed significant improvements in sensitivity and movement. I results published in Nature Communications have confirmed the safety of the approach and opened new perspectives for the regenerative medicine applied to the nervous system.
In Italy, the IRCCS Casa Sollievo of Suffering is carrying on innovative trials with brain stem cells for neurodegenerative diseases, demonstrating that our country is at the forefront in this sector.
The path is set, the direction is perhaps the right one.
A good dose of scientific caution is needed. Phase I trials are primarily designed to verify safety, not efficacy. We will have to wait for studies on larger populations to understand if this therapy really keeps its promises.
For the first time in the history of medicine, however, we have an approach that aims at complete regeneration of the spinal cord, not just damage containment. Fifteen million people in the world live with paralysis due to spinal injuries. For them, this trial represents much more than a medical experiment: it is the concrete possibility of rewriting their own future.
The next decade could be the one in which we stop seeing spinal cord injuries as final sentences and start seeing them as solvable problems. It will be wonderful.
