It begins with a fall, a crash, or a sudden jolt. In a split second, the spinal cord shatters. For millions, the damage is permanent. But in Shanghai and Suzhou, a group of scientists believes that might soon change.
This May, a biotech startup named XellSmart Biopharmaceutical received rare dual approval from both U.S. and Chinese regulators to launch a Phase I trial for an experimental treatment. The therapy is designed to repair spinal cord injuries using neurons grown in a lab.
The trial, described as the first of its kind, is being led by the Third Affiliated Hospital of Sun Yat-sen University in China. The goal: to test whether specialized nerve cells can be safely implanted into people whose spinal cords were recently injured.
“This is the world’s first registrational clinical trial of an off-the-shelf, allogeneic, iPSC-derived, subtype-specific, regenerative neural cell therapy for spinal cord injury,” the company announced in a May press release.
Growing Neurons, Growing Potential
The treatment, called XS228, is made from induced pluripotent stem cells, or iPSCs. Scientists reprogram adult cells, such as skin cells, back into a stem cell-like state. Then, they coax them into becoming neural progenitor cells, the kind that eventually grow into motor neurons.
These lab-grown cells aren’t taken from the patients themselves. Instead, they’re made from healthy donors. That makes the therapy “off-the-shelf” — a term that signals its wider reach since it can be administered without the need for patient-specific cell matching.
In preclinical studies on animals, the results looked promising. The cells integrated into damaged spinal cords, grew new axons, and connected to the host’s own nerve tissue. The treated animals began to move again, showing signs of regained control.
“In animal models of SCI, transplantation of iPSC-derived neural progenitor cells demonstrated neuronal integration, axonal growth, and functional recovery,” the company stated.
Can Lab-Grown Cells Mend Broken Spines?
Spinal cord injury is devastating and common. Globally, more than 15 million people live with the condition. Each year, over 100,000 people in China and about 18,000 in the United States experience a traumatic spinal injury.
Recovery is limited. Today’s treatments mostly focus on stabilizing the spine and offering physical therapy. There is no proven way to repair the damage.
That’s what makes this trial historic. For decades, scientists have dreamed of rebuilding the spinal cord. Some tried using stem cells. Others experimented with gene therapy or electrical stimulation. Many of those efforts stalled in early stages — or never made it to human testing.
XS228 marks a new approach. Unlike earlier therapies, it uses subtype-specific neural progenitors — cells tailored to become the exact kinds of neurons lost in spinal injuries.
“XellSmart aims to redefine possibilities for SCI recovery — bringing a new hope to patients,” the company said.
What Happens Next?
The clinical trial will begin with a small group — likely 60 patients — who suffered spinal injuries just weeks before enrolling. Some will receive XS228. Others will get a placebo. Over six months, doctors will measure how well they move, feel, and function.
As with all first-in-human trials, the main focus is safety. Can these transplanted cells survive? Do they trigger immune responses? Will they behave as expected — or not at all?
If the results are positive, the therapy could move into larger trials in the years ahead.
Of course, setbacks are possible. Cell-based therapies are notoriously difficult to deliver and monitor. But researchers are cautiously optimistic.
In the broader landscape of regenerative medicine, XS228 is part of a broader revolution. Across the globe, scientists are exploring how iPSCs can be turned into retinal cells to reverse blindness, or heart cells to patch damaged tissue. Now, they’re aiming at the spinal cord.
The dream of healing paralysis has always lived at the frontier of science. With this trial, that frontier moves a little closer.
