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**member325671** · 26 Sep 2005, 4:50 PM

Thanks Max but,

This article presents nothing disheartening.....thankfully the World expands further than the USA and overseas therapies will ultimately hold the key.

We'd be fools to think that the U.S would be at the very forefront anyway

**tucker** · 26 Sep 2005, 5:01 PM

We might have been better served if the 3 billion pledged by California went to the China Network of South Korea.

**DougB** · 26 Sep 2005, 7:36 PM

It is good that the message of 'approach with caution' is out there. This lets the protesters know that we do get that message. However, I think the majority of people, through the medium of the likes of Dr. Wise Young, Christopher Reeve and the like support the 'Go Forward' approach and are sick and tired of waiting for a mouse to say " Oh yeah, that feels better....I can feel my feet!". World renowned researchers, bioethicists and health law Directors such as Timothy Caulfield at the Canadian Law Institutes agree that science has moved to the point where human clinical trials are not very far away from being very feasible. Think positive everybody!!

**TEION** · 27 Sep 2005, 3:07 AM

Cowards...

what a bunch of cowards. What is it with the scientist in the USA? They know the desperation of those with spinal cord injuries? Give me a break. They have no damn idea. If they did they wouldn't be dragging there asses like they do. Other countries are sailing by us...thank god. If those with SCI's had to depend on these smucks you might as well just throw in the towel. The article states that we shouldn't rush to human trials just because of this "ONE" positive outcome. ONE! WATDAFU! My wife suffered from a spinal cord injury 10 years ago and we have read about a many positive results all involving mice. I think all this is pathetic. The cure is there. Why don't they want to help anyone?

**Wise Young** · 27 Sep 2005, 5:33 AM

Please don't be too hard on Arnold Kriegstein. He is a good friend of mine and a very good scientist. He is simply voicing caution which is something that I have done so as well, that we must be careful when all the eyes are trained on the first clinical trials of embryonic stem cells and opponents of embryonic stem cell research are waiting to pounce on the first failures. This is also a caution that Woo-suk Hwang has voiced as well when asked whether he was ready to transplant the cloned stem cells that he had obtained from 11 people, that more studies are needed to establish the safety of the cells.

There will be spectrum of voices on the subject, some urging all-speed ahead and some urging caution. We should seriously consider both the risks and benefits of embryonic stem cell transplants before throwing all caution to the wind.

The first embryonic stem cell transplants were made by John McDonald and his group in 1999 when they transplanted mouse embryonic stem cells into rats with contusion injury. They did it in rats with "incomplete" injury resulting from a 12.5 mm contusion. The cells were predifferentiated in culture with retinoic acid to more neural lineages before transplantation. The cells myelinated axons in the rats and they showed better locomotor recovery. Then Doug Kerr and his group transplanted pre-differentiated mouse embryonic stem cells into rats with viral-induced motoneuronal loss, showing that these cells were able to produce new motoneurons and that, when cAMP or phosphodiesterase inhibitors were used, the motoneurons sent axons out the spinal roots. The rats recovered more neurological function. Rats that did not get the cAMP or PD inhibitors did not recover as much. To my knowledge, no embryonic stem cells have been transplanted into human.

There have been many studies suggesting that fetal neural stem cells are beneficial in spinal cord injury, published by Okano, et al. at Keio University in several species including monkey. Recently, the Reeve-Irvine Center published an article in the PNAS reporting that fetal human neural stem cells transplanted into mice will remyelinate and restore function in mice after contusion injury (see http://carecure.org/forum/showthread.php?t=52269). These too were predifferentiated. Please note that this study did not emphasize the fetal origins of the cells but it was funded by a small business innovation grant from NIH. The safety of fetal cell transplants into the spinal cord appears to be reasonable. I estimate that over a thousand people have received fetal cell transplants of various kinds, except for one case that was reported in Vancouver last year, I don't think that I have ever seen or heard of a case of tumor formation from such cells. One reason may be because fetal cells are seldom matched for histocompatibility between the donor and host, and it is likely that most such transplants may be eliminated by the immune system after several months.

I have previously summarized animal studies that showed beneficial effects of bone marrow stem cells transplanted into the spinal cord http://carecure.org/forum/showthread.php?t=21448 and there is one recent Korean human clinical trial showing that bone marrow stem cell transplants and GM-CSF http://carecure.org/forum/showthread.php?t=49996 improved recovery in patients with complete spinal cord injury. There is of course the recent much-publicized case of a Korean patient who received umbilical cord blood transplant to the spinal cord that was just recently published http://carecure.org/forum/showthread.php?t=52347 As I have pointed out before, there is a group in Zhengzhou, China, that has transplanted bone marrow stem cell autografts intrathecally into over 200 patients after spinal cord injury. I don't get the impression that they are getting dramatic recovery but I don't think that one can tell without doing controlled studies since recovery of patients during the acute phase after injury is so variable. So far, the safety record of bone marrow autografts appears to be reasonable.

Regarding risk, many early reports suggest that direct transplantation of embryonic stem cells will result in formation of teratomas (embryonic stem cell tumors that contain many different kinds of cells). In fact, Dr. Woo-suk Hwang presented several slides in his talks showing teratoma formation from his cloned human embryonic stem cell lines when transplanted into animals. This was part of his proof that he indeed has obtained pluripotent embryonic stem cells. So, it is clear that embryonic stem cells must be pre-differentiated before transplantation. Can you imagine what would happen if the first patient that gets an embryonic stem cell transplant gets a teratoma. Opponents of embryonic stem cell research will say, "I told you so". Use of embryonic stem cells in human would be shut down for a long time.

On the other hand, at the present time, embryonic stem cells are the only cells that have been able to produce new motoneurons in the spinal cord, in animal studies. The other cell types have so far have shown remyelination and possibly regeneration resulting from the transplants. For somebody with ALS (amyotrophic lateral sclerosis) and who is dying, there is currently no other choice. For such people, the risk of the therapy is less than the risk of death. Note, however, because ALS is a genetic disease, it is probably not appropriate to transplant autografts since that would be putting the cells with the same genetic disease into the spinal cord. HLA-matched heterografts will probably be necessary. I think that it is likely that the first embryonic stem cell therapy will probably be tried in patients with ALS or similar disease. As more experience is gathered and the risk is better defined, I think that it may be tried in patients with less deadly disease and conditions.

Wise.

**cali** · 27 Sep 2005, 1:40 PM

i really want to walk, obviously, but i want it to be as safe as possible so i don't mind waiting as long as i need even though i'd rather not

**Cspine** · 27 Sep 2005, 2:21 PM

Originally posted by cali

i really want to walk, obviously, but i want it to be as safe as possible so i don't mind waiting as long as i need even though i'd rather not

that's exactly how i feel.

i think what we all tend to forget is even in medicine you don't get a second chance to make a first impression. if the first clinical trials go perfectly then everybody will jump on the stem cell train and we'll all get fixed up in no time. if all the subjects of the first trial die because of a cut corner or overlooked detail then sci stem cell research will basically be writen off as quackery.

**sbdspray** · 27 Sep 2005, 4:09 PM

enough already

Researchers are trained to be centered and disciplined, passive to a patient's individual needs and/or requests. Throughout their careers they've seen many desperate people die due to the ravages of a damaged Central Nervous System. With regards to SCI, since most patients are alive, there is even less pressure to deflect thier needs. It is my stern belief that the longer someone lives with a chronic SCI, the more unfixable the dead tissue, and unused body parts are going to be. It's just a matter of time before scientists start completely dismissing chronic SCI sufferers, telling us to support research for tomorrow's generation. I, for one, will not give funding for research that is aimed to help someone not even conveived yet.

**Chris Chappell** · 27 Sep 2005, 7:44 PM

cspine - I believe that you are correct.

**Leif** · 28 Sep 2005, 4:35 AM

Originally posted by sbdspray

Researchers are trained to be centered and disciplined, passive to a patient's individual needs and/or requests. Throughout their careers they've seen many desperate people die due to the ravages of a damaged Central Nervous System.

I have to argue this comment a little bit. Over here we are in the process to form a new government after the elections we just had. The new three party coalition that will try to agree upon making a new government just sat down and started negotiations that will last for a couple of weeks before they will agree upon something.

One important issue here is that the new three party coalitions hopefully will agree upon a change in our Biotechnology law. We have a very rigid law that don’t legalise embryonic stem cell research nor does the law allow for therapeutic cloning at the present.

So what is important at this point? Lobbyism and being in media is important for those who will have a change, as well for those who oppose (there has been few of those) a change. This could have an impact on the negotiations between the three parties.

Back to your argument; For promoting stem cell research the last week and especially the last days in media we have.

The Norwegian Researchers organisation has been in the media several times telling the politicians to change the existing law. We have the Norwegian Medical Practitioner organisation doing the same. In addition we have had Professors in ethics supporting a change. We have had in addition several other medical Professors from all over the country arguing both in TV and writing in news papers where they requires a change in our Biotechnology law. This is great. - I also used to believe that they was disciplined etc. and also that they did not to interfere with politics and the politicians decision making process, but I was wrong – they do! In addition I know about some more Professors in the field that will be on TV soon. All of them argue that we need to do research on stem cells for finding cures for patients etc. The last Professors I referred to will also directly address the SCI situation. All of them are putting pressure on themselves.

On the other hand. Where are handicap organisations? Where is the Norwegian spinal cord organization? They should have been in the media all the time fighting for stem cells, but no! They are missing in the media arena all of them! Totally fucking unbelievable! Where have they been the last years, haven’t they heard about stem cells? And don’t they know that just right now is an important time for lobbying and going in media for the stem cell case since a new Government is formed? I don’t’ know their mindset at all.

So by this it is clear to me that researches and scientists has done a tremendous and overwhelming job here for the stem cell case – the patient organisations not such god a job.

**Leif** · 28 Sep 2005, 4:53 AM

Clinical trails; when clinical stem cell trials for dealing with SCI starts in western world it will not be one single approach. Stem cells are a word for a variety of stem cells. There will be many approaches; there will be approaches with combination therapies and so on. Some of those clinical trials will work better than other clinical trials and some clinical trials will also fail. By this I find it hard to believe that stem cells will be written off just because some of the approaches don’t serve our expectations. The clinical trials will also be performed in many countries. The debate will be different inn all of those countries, but the stem cell research will move on – it is here to stay. Of course there will be different opinion between researches when to start those trials, but when some researchers believe they have sufficient knowledge to start - they will. When this will happen I don’t know, but it will start sooner or later. I’m not an expert, but this is common sense in my opinion.

Call me naive if you like, but I don’t think I am. You can also say that the hope itself is enough for me, but it is not. If we look at all the research and facts going on these days I strongly believe there is something here. And if you see all the scientists, researchers, bio engineer’s etc. etc. working on this there must be something here – all those people can’t be wrong.

**DougB** · 28 Sep 2005, 12:53 PM

I have to agree with Leif. That many people can't be wrong. And, he is right, the disabled community has got to keep their collective foot on the gas. Keep making noise. Squeaky wheel gets the grease. They will never write off chronics! There are 3,4,5,7,9,10 year old kids out there right now with chronic SCI. Kids of all ages for a fact. Who in their right mind would write them off. C'mon, this plight is all of ours and 'ALL' of us will come out of it with a collaborative, stick together attitude. No one gets left behind!

**dr_bubo** · 1 Oct 2005, 4:19 AM

The nature of this prohibits any fast progress.

Only with regulation allowing and with injured people willing to risk even worse condition at the end as before can make this faster.

There is now no indication of either to be realized.

**Wise Young** · 1 Oct 2005, 9:08 AM

Leif, when I gave my talk at the Nordic Spinal Cord Injury Society, I urged all the participants to start thinking about spinal cord injury trials. I told them that they are in a unique position to establish a clinical trial network in all of Scandinavia and the health care system in Scandinavia is ideally suited for clinical trials. They have long term followup, skilled surgeons, and brilliant scientists. They need to join forces and work together. I hope that they agreed with me. It is a unique opportunity for Norway, for example, to lead the effort. Wise.

Originally posted by Leif

I have to argue this comment a little bit. Over here we are in the process to form a new government after the elections we just had. The new three party coalition that will try to agree upon making a new government just sat down and started negotiations that will last for a couple of weeks before they will agree upon something.

One important issue here is that the new three party coalitions hopefully will agree upon a change in our Biotechnology law. We have a very rigid law that don’t legalise embryonic stem cell research nor does the law allow for therapeutic cloning at the present.

So what is important at this point? Lobbyism and being in media is important for those who will have a change, as well for those who oppose (there has been few of those) a change. This could have an impact on the negotiations between the three parties.

Back to your argument; For promoting stem cell research the last week and especially the last days in media we have.

The Norwegian Researchers organisation has been in the media several times telling the politicians to change the existing law. We have the Norwegian Medical Practitioner organisation doing the same. In addition we have had Professors in ethics supporting a change. We have had in addition several other medical Professors from all over the country arguing both in TV and writing in news papers where they requires a change in our Biotechnology law. This is great. - I also used to believe that they was disciplined etc. and also that they did not to interfere with politics and the politicians decision making process, but I was wrong – they do! In addition I know about some more Professors in the field that will be on TV soon. All of them argue that we need to do research on stem cells for finding cures for patients etc. The last Professors I referred to will also directly address the SCI situation. All of them are putting pressure on themselves.

On the other hand. Where are handicap organisations? Where is the Norwegian spinal cord organization? They should have been in the media all the time fighting for stem cells, but no! They are missing in the media arena all of them! Totally fucking unbelievable! Where have they been the last years, haven’t they heard about stem cells? And don’t they know that just right now is an important time for lobbying and going in media for the stem cell case since a new Government is formed? I don’t’ know their mindset at all.

So by this it is clear to me that researches and scientists has done a tremendous and overwhelming job here for the stem cell case – the patient organisations not such god a job.

Announcement

For stem cell experts, hopes are longterm/Human trials still years away in effort to cure paralysis

For stem cell experts, hopes are longterm/Human trials still years away in effort to cure paralysis

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