Wise YoungPosted: October 18, 2014
I’m going to do something I have not done before. In the last few weeks I gave several talks, and I realize that some of the videos I showed were distracting the audience . . . they weren’t listening to what I was saying. So I’m going to talk for 20 minutes before I get to any slides.
I’m also doing something I haven’t done before. I’ve actually written up what I’m going to say, because I want to cover all the territory.
(Okay, I’m going to recap this as he goes, but I’ll get you the text itself if he’s wiling to share it.)
Most of history, no hope for repairing damaged cords.
Discussing some papers and history that are the background for his work in the China Clinical Trials . . lithium, lithium, lithium. Umbilical cord blood cells. They’ve done six trials.
1. 20 complete sci people given lithium
2. 40 subjects double-blinded to lithium or placebo . . . significantly reduced neuropathic pain in 5 out of 6 people treated. Unexpected result.
3. 60 subjects with severe neuropathic pain ( more than 5 out of 10) . . . have randomized 42 subjects from this trial. Half of them report significantly less pain, even 6 months after the trial has stopped. 18 more patients left to randomize and 6 months to evaluate them.
4. Transplanted 1.6 or 3.2 million HLA-matched umbilical cord blood cells, having spent 4 years developing a procedure to store and ship. They’ve seen no adverse effects. At one year, 2 of the patients had nerve fibers crossing the injury site. We don’t know if these are axon fiber bundles, but it’s hard to imagine what they are. Very disappointingly, none of the people who had these fibers growing had any motor return, though some did get sensory return.
5. At the end of 2011, beginning of 2012, we did 20 patients with chronic complete injuries – except one who was a c3 ASIA C. They got 1.6 or 3.2 or 6.4 million cells. Then we did a fourth group who got 6.4 million cells and a bolus of mp. And finally there was a fifth group that got all of that plus lithium.
6. 6.4 million cells into 13 subacute patients + lithium
Now talking about Kun Ming trial, which I think is #5 above. No study before this had ever shown recovery of walking . . . 3 of the subjects quit training partway into the study; they had fractures in their legs which were apparently there before the study. At 3-6 months, 75% of the patients were walking in rolling walkers with someone behind them with a rope to keep their knees from buckling. One patient was walking without help. When they went home, those who kept walking kept getting better.
Okay, I can’t keep up with all the data he’s reading . . . the gist is that there were people in these studies who regained walking. 10% of them could walk more than 100 meters without help. By one year 55% of the patients were no longer using catheters.
We don’t know what this is all about; we’ll have them back for a 2 year follow up.
The data seems to be all over the map . . . 17 subjects who got intensive motor training, and 15 of them recovered some walking.
Based on these results, we’ve proposed new trials around the world. They plan to sort people into groups that get one of five possible treatment menus. All will get locomotor training, no matter what else they get. The 5 menus are surgery only, surgery + lithium, surgery + lithium + cells, surgery + lithium + cells + MP, and um . . dang it.
But wait . . . we have people walking who seem not to have any voluntary motor scores. What? If you don’t have voluntary motor scores, how are you walking?
Why was the first study controversial? Because the idea that taking a couple of lithium pills could have an impact on the volume of cells was just weird. You’re not getting more cells, you’re getting cells with more dendritic trees.
What was the dose? The same dose that’s used to treat manic depression. It’s correlated with blood volume.
Has anybody ever gotten worse neuropathic pain from these studies? In the double-blind randomized study of 40 people, 2 of the placebo people got worse pain, and 2 of the lithium people got increased pain, but it was less than the 5-10 score.
Still HLA-matching? Yes, (goes into some technical detail about how this works)
Do the people who don’t cath have control? We estimate that half are using the crudet procedure, which is scrunching down and pressing on their bladders. I wondered if it had to do with the cost of catheters — nurses say no, it’s not that.
Describe walking with assistance. There’s someone behind using a rope to keep the person’s knees from buckling. They use a rolling walker for support.
Reggie says that they need to talk. I’d say.