Comment by WheelsAtLarge | Hacker News Reader

Comment by WheelsAtLarge | Hacker News Reader

This is great news but I would be a bit cautious about it. I love the idea that stem cell therapy can cure spinal cord injuries but I know for a fact that spinal cord injuries are unpredictable as to what the long term impact will be.

Professionals in the field know that people with these injuries can regain mobility months and years after the accident.

I know of a few extreme cases where individuals were told they would never walk but within a few months were able to walk out of the hospital.There are other more common cases where movement to limbs increased in time.

I point this out not to throw water at the cure but it's a bit premature to celebrate and get people's hopes up without knowing the reality of the treatment.

I love the idea but one person does not prove a cure. I sincerely hope that Kris' improvement continues and that the therapy is as good as it's hoped.

The Christphere Reeves foundation has a great area on the subject.

https://www.christopherreeve.org/research/reeve-stem-cell-re...

Here's a press release from the company: http://asteriasbiotherapeutics.com/asterias-biotherapeutics-... They're doing a dosing study, with escalating number of cells injected. Results are promising, but the study includes no controls, so there is no way to know if the cell-based treatment is better than no treatment.

The current study is open-label (i.e. not blinded) single-arm (no controls). Once they establish the right dose, they will need to do a double-blind randomized controlled study to find out if it works.

Blinding isn't especially important for a procedure like this. An RCT would be a sufficiently strong study design, in my opinion.

If you were going to RCT, in this instance, why would you not blind? Sham injections - it's a no brainer. Why get the second best level of evidence if you can get the best?

It's a needle to the spine...

Hmm... maybe use people who require surgery/anesthesia and just tell them they were injected? I've taken a few courses on clinical trial design just out of curiosity, but now I find I can't really say anything substantial about my own idea. Back to the courses?

Sham surgery is a thing (there have been some interesting studies looking at the efficacy of knee surgery compared with sham surgery for a variety of common knee issues...)

https://www.youtube.com/watch?v=P_pAdg8Y70Y

People much smarter than me have been wrong about the placebo effect in the past, but I think it's pretty unlikely that a placebo effect will result in the restoration of function after a traumatic spinal cord injury...

This procedure clearly needs to be tested against "doing nothing" (but it's impossible to blind against that, obviously). You only need to blind a study when you are testing against a placebo.

> I think it's pretty unlikely that a placebo effect will result in the restoration of function after a traumatic spinal cord injury...

You would be amazed. The placebo effect is surprisingly powerful.

https://en.wikipedia.org/wiki/Sham_surgery

Yeah, I'm familiar with the effect (I linked to a Healthcare Triage video on that topic in another leaf). I still think the placebo effect is likely to be very small when it comes to the restoration of movement (as opposed to reduction in pain, or other symptoms).

Yes, but the only way to know for sure is to do the experiment. Wouldn't it be cool if you turned out to be wrong?

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