Clinical Trials in China Yielding Promising Results

The China Spinal Cord Injury Network (ChinaSCINet) recently conducted Phase II clinical trials that suggest umbilical cord blood mononuclear cell transplants and lithium can regenerate and improve recovery in people with chronic complete spinal cord injury.

The team based in Kunming have completed a clinical trial assessing effects of umbilical cord blood mononuclear cell transplants in 20 subjects who averaged 7 years after complete spinal cord injury.  The subjects received intensive walking training for 3-6 months.  At 6-12 months, 15 of the 20 subjects (75%) could walk in a rolling device with minimal assistance.   Another 2 subjects could walk without any assistance using a four-point walker.  These results are much better than expected.

This obviously is encouraging news. I personally fit right into that description, and the therapy I currently do lines up very closely with the exercise-based intensive walking training the trial participants are doing. Just gimme some baby blood and I'll be good to go!

The following caveats should be kept in mind.  First, these are preliminary results from Phase II clinical trials that must be confirmed in Phase III randomized controlled trials. Second, it is not clear whether intensive locomotor training, “untethering” surgery, cell transplant, or a combination of the three therapies are responsible for the observed walking recovery. Third, while the subjects showed improved walking and descent of sensory levels, they did not show much improvement in their motor scores.

Of course, caveats. Bunch of party poopers. With so many variables involved in the therapy, though, it difficult to tell exactly what is working and what is not. So what's next?

ChinaSCINet proposes to carry out a multicenter Phase III clinical trial in China.  This trial will test 120 subjects with chronic complete spinal cord injury, randomized to four groups with different therapies: untethering surgery only, surgery plus lithium, surgery plus transplant, and surgery, transplant plus lithium.  All subjects will undergo 3-6 months of intensive locomotor training and then assessed for 2 years.
This trial (called CN103) will be the first surgically controlled clinical trial to assess a cell transplant therapy.  It will provide definitive answers to three questions.  First, does transplantation of umbilical cord blood mononuclear cells improve walking recovery compared to surgery alone?  Second, does surgery and lithium improve walking recovery compared to surgery alone?  Third, does lithium improve the effects of the cell transplants on walking recovery?

So maybe I will move to China....OK, maybe not, but this progress is exciting.

This trial should have a very substantial impact.  If umbilical cord blood mononuclear cell transplants improve walking recovery, China will be the first in the world and in history to show a therapy that restores function in chronic complete spinal cord injury.  The trial may show that intensive walking training and “untethering” surgery improve walking in people with chronic complete spinal cord injury. This would also be very worthwhile.
Many people are waiting for therapies to restore function.  Some have died while working for the cure, including Christopher Reeve and Bun Tsai. The trial provides hope to millions of people worldwide who have been told by their doctors that they should not expect to walk again after spinal cord injury.  Restoring walking on earth is a greater achievement than walking on the moon.

The moon!