A 2016 Chinese trial is now the basis of a phase III clinical trial that will look to assess the treatment efficacy with 120 new patients. The trial involved participants suffering from chronic SCI showing unprecedented recovery of function. This after receiv-ing umbilical cord blood mononuclear cells (UCBMNC) infusions and underwent extensive locomotor training.
Phase I and II results were unprecedented. The phase I, involving eight participants, opened the safe progress for the second to ensue. The phase II included twenty participants. The results of both trials astounded Dr Wise Young, director of the W.M. Keck Center for Collaborative Neuroscience at Rutgers University. He commented, “We need to bring spinal cord injury back into the mainstream of medicine. We’ve been shut out because for the last 12-15 years there have been no clinical trials of anything. It’s just a bunch of people sticking things into the spinal cord and not doing any control studies and being criticised.”
Of the participants who took part in the year-long trials all but one of them had complete SCI injuries ranging from C3 to T11. Participants in the phase I trial in Hong Kong averaged 14 years post-injury. In Kunming, the phase II trial participants were on average seven years post-injury.
At both sites, participants received injections of UCBMNC and a large dose of methylprednisolone. This was in addition to surgery to de-tether their spinal cords. The Kunming (phase II) participants also received intensive locomotor training. The training spanned six hours per day, six days per week for three to six months, covering long distances with a rolling walker. Par- ticipants in Hong Kong received no such training in the months following.
Results from the Phase I trial suggested, through imaging, that the spinal cords had regenerated somewhat. But the results from the Phase II trial, which combined locomotor training, was particularly ground-breaking. None of the participants in Kun-ming could walk more than 10 meters without substantial as- sistance at the beginning of the trial and the majority were not even able to stand without help. However, Dr Young explained that “at one year after treatment 75 percent (15/20) of the participants in Kunming recovered the ability to walk long dis- tances in a rolling walker with minimal assistance. Thirty-five percent (7/20) could walk without such assistance using either a four-point walker or crutches.”
“When they went home [however], some of them did not have devices or people to help them walk and several regressed. However, 35 percent continued to walk and became household walkers, preferring to walk for distances up to 100 meters, but using their wheelchairs for longer distances.”
He explains that 60 percent of the participants became completely independent and no longer needed any help for bladder and bowel function. Fifty five percent stopped using catheters altogether.
Now, to build on this work, Dr Young, with worldwide stake- holders and funding, is implementing phase III – the Cord Blood Mononuclear Cells ± Lithium Trial. If they receive the regulatory approvals and adequate funds, the China Spinal Cord Injury Net- work (ChinaSCINet) will start the clinical trial in Mainland China, Hong Kong and Taiwan.
Such a trial will build on the efficacy of earlier results. It will incorporate lithium to reinforce the regeneration-promoting effects of chondroitinase ABC on rubrospinal neurons as it is proven, according to Yick, et al. to strongly stimulate umbilical cord blood mononuclear cells (UCBMC) to proliferate and se- crete neurotrophins which regulate development, maintenance, and function of vertebrate nervous systems, in vitro and in vivo.
Participants interested in entering a clinical trial of this nature, should do so by visiting www.chinascinet.org.
Yick LW, So KF, Cheung PT and Wu WT (2004). Lithium chloride reinforces the regeneration-promoting effect of chondroitinase ABC on rubrospinal neurons after spinal cord injury. J Neurotrauma. 21:932-43.