What the World news said today about Dr Hans Keirstead first patient.

[maryonwheels46]

Just repeating what they said today on the 5 o'clock World news.

Dr John Lapoot (sp) was doing the talking. In Atlanta, Dr Hans Keirstead injected his first patient with embryonic stem cells at the site of injury. Hoping that it will insulate the site and restore the damaged spinal cord so it will work again.

They are using a patient that has been hurt from 7 to 14 days and has been injured from the chest down.

They hope to include 10 more people in the next 2 years.

After seeing the results they want to start using patients that has been hurt for months to years.
I am very excited to hear what will happen. B and B function and movement. WOW
Mary

[Foolish Old]

How will they know what to attribute to the therapy? In such a new injury, can anyone predict what would have happened without the stem cells? Isn't that why trials require large numbers and a randomly selected blind control group?

[rjames]

Originally Posted by Foolish Old

How will they know what to attribute to the therapy? In such a new injury, can anyone predict what would have happened without the stem cells? Isn't that why trials require large numbers and a randomly selected blind control group?

That's part of what has taken so long to bring this therapy to trials, deciding the inclusion criteria , how to administer injection without doing damage to the cord, how many cells to use, outcome measures and so on. They are writting the handbook for this and future stem cell treatments.

I'm quite sure they have figured out exactly what type of complete injury to treat and know that recovery will not come with out intervention of their treatment. Like any Phase 1 it is only to test safety, since hESC's have never gone into humans they are erroring on the side of caution and will increase the patient population once the phase 1 is complete and successful. I beleive that the random/blind control group is used in phase 3 trials, phase 2 trials test dosage.

[PaidMyDues]

That is the gold standard, but a person with a "complete," i.e. ASIA A SCI at 72 hours post injury is unlikely to improve below the level of the lesion.

[Curt Leatherbee]

I'm surprised there is not more word from the religion fanatics about this, or maybe that news will come tomorrow I guess.

[kate]

Originally Posted by rjames

I'm quite sure they have figured out exactly what type of complete injury to treat and know that recovery will not come with out intervention of their treatment.

My understanding is that the trial is focused on subacute injuries (more than a few days but less than two weeks) because in the lab the therapy worked on animals with those injuries -- but not on injuries that had gone to the chronic phase.

As far as how we'll know if any recovery is due to the treatment or would have happened anyway, we do have a whole universe of data suggesting what percentage of injuries that are ASIA A in the subacute period get to ASIA B or beyond. The control group for this safety phase, in other words, is everybody out there who had a diagnosis of ASIA A at two weeks.

I really can't wait to hear Ed Wirth (medical director at Geron) tell us in person what's going on in Phoenix next month. Working2Walk!

Like any Phase 1 it is only to test safety, since hESC's have never gone into humans they are erroring on the side of caution and will increase the patient population once the phase 1 is complete and successful. I beleive that the random/blind control group is used in phase 3 trials, phase 2 trials test dosage.

I don't think there will ever be a random/blind control group for this kind of therapy. If Phase II trials can identify the best dosage and show any efficacy at all, it would be incredible to ask a newly injured person to risk NOT getting the cells -- because once that window closes, it's closed.

Until we have a chronic treatment, I mean.

[0xSquidy]

But they should take another selected group that won't get the surgery but that will go under the same physiotherapy just to make sure, right?

[keeping on]

Curt,they might be dumb enough to contest the progress of stem cell research but not so to stand in the way of this trial. Who knows?

[Imight]

I was reading about this earlier. It's in ATL, but Dr Hans Keirstead is out of Irvine, CA, and the article made no mention of Dr Keirstead....hmmmm

One of his technicians married my housemate that lives in the guesthouse. When she gets home I'm going to ask her about this....She's no longer with him as of June, but I'm sure she has information.

BTW, she now works for USC who is set to dip into the stem cell clinical trial race soon too, but you didn't hear that from me......

[keeping on]

Imight, there are a whole lot of trials that will be starting; let's hope that results are conclusive and are good.