Regenerative Cell Therapy to Reverse Spinal Injuries Approved for Human Trials

What Happened?

This week the U.S. Food and Drug Administration and China’s National Medical Products Administration both approved a new regenerative cell treatment which could reverse spinal cord injuries. The trials will be conducted by Sun Yat-sen University's Third Affiliated Hospital in China, a specialist in treating and researching these complex spinal injuries.

The creator of the treatment, Chinese biotech company XellSmart, issued a statement highlighting the need for better treatments saying, ‘Each year, China and the U.S. report approximately 100,000 and 18,000 new cases of spinal cord injuries respectively – equivalent to nearly 10 and two new cases every hour.’

Why it Matters

Presently, most spinal cord injuries have no cure and are irreversible. Though treatment options allow varying degrees of mobility for those who suffer from spinal cord injuries, most are permanently beset by paralysis which can cause a host of chronic health problems.

According to Bronwyn Thompson of New Atlas, the phase one portion of the trial will test for safety and efficacy and should be completed by some time next year. If successful, phase two would then be expected to begin in 2028 at the earliest. If both phases one and two are successful, the new therapy could be then mass produced and available within five to seven years.

How does the new therapy work? XellSmart’s treatment harnesses pluripotent stem cells to regrow cells needed to repair the damage done to spinal cords. Pluripotent stem cells are immature stem cells that can develop into specific cells, including the kind needed to replace damaged or dead neural cells caused by spinal cord injuries. Crucially, XellSmart’s regenerative cell treatment is based on a wholistic approach, meaning it could eventually restore normal functions to people who are currently paralyzed by regrowing lost nerve cells.

Spinal cord injuries can not only cause paralysis, but they can also lead to a number of secondary and lasting health problems. The loss of sensation also means a loss of the ability to feel pain, which can prevent sufferers from realizing they’ve been injured. That can in turn cause minor infections or other problems to worsen until they become serious and life threatening. Breathing difficulties and lasting depression are also common among those who have suffered spinal cord injuries.

Stem cell research in the United States has been controversial, and while there is no ban some states place restrictions on funding for stem cell research, which can slow down progress. China has no such restrictions on stem cell funding or research.

How it Affects You

For those who suffer from spinal cord injuries or who have loved ones who are paralyzed, the new treatment offers hope. Though still several years away from being commercially available, human trials are an important step towards reaching the goal of reversing spinal cord injuries for good.