Clinical Trial Results

[Jane]

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Osiris Therapeutics, Baltimore, MD is in clinical trials for stem cells for heart and others.

I have Emailed them and they have been most responsive in answering my questions and referring me to their research. It is great to know this is being done for those of us on the East Coast.

See their trials under Press Release, particularly March 25th

http://www.osiris.com/

 

[Jeannine]

Hi Jane
We have posted about Osiris in the past and I think it's fabulous.

I have been watching them very closely and even considering buying some stocks.

 

[cellmedicine]

Osiris paving the way

I agree that Osiris is doing phenomenal work. Adult stem cells used in an autologous manner (from the same patient) have demonstrated positive results in numerous cardiac trials.

HOWEVER, the problem with autologous stem cells is not medical but a business problem. There is no way to commercialize them, in other words no company will put the hundreds of millions of dollars needed to meet the FDA requirements for selling and commercialization of these cells if they can not be protected. This is why the work of Osiris is so important.

Osiris, by generating "universal donor" cells which they own the patents for, are in the position to go through the whole FDA/EMEA system to get them approved so that they will be available in a manner that is reimburstable by insurance companies. Unfortunately, for heart failure Osiris is still in Phase I/II, which means it will still be several years before they become available in the US for general use. That is why some clinics are offering stem cells as a fee for service, usually in an autologous manner.

In any case I am happy to hear that others feel the same way we do about the great work of Osiris.


Administrative Edit - Please do not post company sponsored/provided/promotional links all through the forums. I have created a forum for this type of posting, please post them in there.

 

[hlichten]

I agree that Osiris is doing phenomenal work. Adult stem cells used in an autologous manner (from the same patient) have demonstrated positive results in numerous cardiac trials. See a video we posted http://www.youtube.com/watch?v=JfSdCYFNdPw

HOWEVER, the problem with autologous stem cells is not medical but a business problem. There is no way to commercialize them, in other words no company will put the hundreds of millions of dollars needed to meet the FDA requirements for selling and commercialization of these cells if they can not be protected. This is why the work of Osiris is so important.

Osiris, by generating "universal donor" cells which they own the patents for, are in the position to go through the whole FDA/EMEA system to get them approved so that they will be available in a manner that is reimburstable by insurance companies. Unfortunately, for heart failure Osiris is still in Phase I/II, which means it will still be several years before they become available in the US for general use. That is why some clinics are offering stem cells as a fee for service, usually in an autologous manner.

In any case I am happy to hear that others feel the same way we do about the great work of Osiris.

Please tell us exactly which treatments you CURRENTLY offer for heart disease at your clinics, particularly in Costa Rica?

Who is this doctor on this YouTube clip, if I may ask? Does he work for your company?

I went to your clinic in Costa Rica, and all I was offered was cord blood-based treatment, which I declined.

 

[Buddy74]

linical Stem Cell Studies

Dear Harv. I just found this site which I find to be quite informative. I have Ischemic Heart Failure due to a heart attack that I had in Sept. of 2005. I was at my Pocono Mountain Summer home at the time and I had no pain just some serious perspiration but I asked to be taken to a hospital some forty miles away in Scranton, Pa. Although I arrived within an hour and still felt pretty good I had to wait for some time before a cardiac surgeon could get to the scene. I was told that possibly some plaque had broken loose and I had one artery blocked 100% and another 98%, I spent six days on a respirator and when I came back to the conscious world I had great difficulty with my breathing upon movement of any kind. I was told I would improve by the cardiologist and needed exercise rehab. I flew back to my home in florida, saw my cardiologist and within a week I was diagnosed with stage three heart failure. My Ejection Fraction has remained between 20 and 25 over the past two and one half years, my breathing remained a problem and I was put on Coreg..ultimately 121/2 mgs. twice a day, diavan, and demadex. I also had an CRT implant (synchronize left and right ventricle input, output) which helped quite a bit. However I still have trouble breathing when walking although I am not in any pain and for the most part do not have any major fatigue or depression problems.I have some ancillary problems from the lack of oxygenated blood through my system, i.e. Anemia and some early kidney failure.
1....I have applied to be a participant in a PHASE TWO clinical study at the Florida Heart Institute as part of study sponsored by the FDA and headlined through the Texas Heart Institute. It will be a stem cell proceduretaken from my bone marrow and introduceded into the inside of my heart, which has some extensive scarring. There will be 20 people in the Florida study and a total of 80 to 100 nationwide at five locations.By the way I am in my 70's and have always lead a disciplined healthy life and would like to have a few more years. One third will be given a placebo, one third a low dose of stem cells and one third a high dose. It is a double blind study and if you take the placebo or given the lower dose there is no plan on having a secondary administration of the stem cells if you receive the placebo or lower amount of stem cells.
Harv, do you or anyone have any questions you believe I should ask and I won't mind your expressing an opinion.
2.. I am interested in the Institute of Cellular Research in Costa Rica and also the hospital in Mexico. Do you have their web-site locations. I could not find them through my searches. The fact that you have been to the one in Costa Rica is interesting to me but it appears they do not use your own stem cells? Any information you can provide would be most appreciated.
Bud

 

[hlichten]

Dear Harv. I just found this site which I find to be quite informative. I have Ischemic Heart Failure due to a heart attack that I had in Sept. of 2005. I was at my Pocono Mountain Summer home at the time and I had no pain just some serious perspiration but I asked to be taken to a hospital some forty miles away in Scranton, Pa. Although I arrived within an hour and still felt pretty good I had to wait for some time before a cardiac surgeon could get to the scene. I was told that possibly some plaque had broken loose and I had one artery blocked 100% and another 98%, I spent six days on a respirator and when I came back to the conscious world I had great difficulty with my breathing upon movement of any kind. I was told I would improve by the cardiologist and needed exercise rehab. I flew back to my home in florida, saw my cardiologist and within a week I was diagnosed with stage three heart failure. My Ejection Fraction has remained between 20 and 25 over the past two and one half years, my breathing remained a problem and I was put on Coreg..ultimately 121/2 mgs. twice a day, diavan, and demadex. I also had an CRT implant (synchronize left and right ventricle input, output) which helped quite a bit. However I still have trouble breathing when walking although I am not in any pain and for the most part do not have any major fatigue or depression problems.I have some ancillary problems from the lack of oxygenated blood through my system, i.e. Anemia and some early kidney failure.
1....I have applied to be a participant in a PHASE TWO clinical study at the Florida Heart Institute as part of study sponsored by the FDA and headlined through the Texas Heart Institute. It will be a stem cell proceduretaken from my bone marrow and introduceded into the inside of my heart, which has some extensive scarring. There will be 20 people in the Florida study and a total of 80 to 100 nationwide at five locations.By the way I am in my 70's and have always lead a disciplined healthy life and would like to have a few more years. One third will be given a placebo, one third a low dose of stem cells and one third a high dose. It is a double blind study and if you take the placebo or given the lower dose there is no plan on having a secondary administration of the stem cells if you receive the placebo or lower amount of stem cells.
Harv, do you or anyone have any questions you believe I should ask and I won't mind your expressing an opinion.
2.. I am interested in the Institute of Cellular Research in Costa Rica and also the hospital in Mexico. Do you have their web-site locations. I could not find them through my searches. The fact that you have been to the one in Costa Rica is interesting to me but it appears they do not use your own stem cells? Any information you can provide would be most appreciated.
Bud

Well, as you may have read, I did go to ICM in Costa Rica, but declined treatment there. I won't go into any great detail, but all they offered was cord blood for heart disease, which I thought was not the way to go. The interesting tidbit is that less than a week after I got back from there, they changed their website to say that they offered human cell treatment. Also, they told me via email and phone that they had treated a lot of cardiac cases, but when I got there, they told me that they had treated ONE patient, and then proceeded to bring his case file for me to see. I had no desire to review one lousy case, stayed a few more days and then left.

As for Mexico, all the COPD patients here (almost all) have been treated at Stem Cell Biotherapy in a Mexico clinic, but they use cord blood cells also. Now, they, or some other clinic in Mexico may do human cell treatments now, but that would not be my choice. Cord blood could be fine, but definitely not recommended for heart disease at this time, only human cells.

My first treatment was with Theravitae in Bangkok. Not recommended. If you do a search for them, you will find my post. VERY expensive, fine doctors, company not recommended. I can tell you more privately if you have interest in them.

 

[Buddy74]

Thank you Harv for your detailed answer to my query. It is interesting to note that the Texas Heart Institute would include those individuals in receiving the stem cell therapy within a six month window. The coordinator of the study I involved with told me that placebo and those taking low dosages would not be allowed to come back for the full dose therapy so it seems that only one in three might actually benefit from the clinical study. I have been told that the clinical study is not about the individuals in the study (18) but more about what they learn from the study for future use.
I will be in touch with the coordinator for some further questions as I also have to have a few invasive tests taken and sent to them (catherization etc.) which will be used as part of the decision making process in order to even be accepted, with more extensive testing once you become a candidate.
Thanks again Harve, We learn so much from people like you who really are pioneers on the frontiers of medicine .
Bud

 

[hlichten]

Thank you Harv for your detailed answer to my query. It is interesting to note that the Texas Heart Institute would include those individuals in receiving the stem cell therapy within a six month window. The coordinator of the study I involved with told me that placebo and those taking low dosages would not be allowed to come back for the full dose therapy so it seems that only one in three might actually benefit from the clinical study. I have been told that the clinical study is not about the individuals in the study (18) but more about what they learn from the study for future use.
I will be in touch with the coordinator for some further questions as I also have to have a few invasive tests taken and sent to them (catherization etc.) which will be used as part of the decision making process in order to even be accepted, with more extensive testing once you become a candidate.
Thanks again Harve, We learn so much from people like you who really are pioneers on the frontiers of medicine .
Bud

I wish I still knew the name of the head stem cell trial coordinator at THI. If you call THI and ask for her name, and send it to me, I am sure it would ring a bell immediately. I have spoken to them about 2 or 3 trials, and in every case EVERYONE gets offered the "real deal" after 6 months. There is no reason why 2/3 of the trial would ever agree to being in the trial otherwise. Just makes no sense. In fact, I have never heard of any stem cell trial anywhere where everyone is not eventually offered the real cells.

 

[Buddy74]

Hi Harv... I have contacted the individual in Texas representing XCEll whom you spoke with regarding my interest in having stem cells implanted for my Ischemic Heart failure in Cologne, Germany. The coordinator remembers you very well and was easy to talk with. The thing that I found bothersome was the fact that they have been in operation since March of 2007 and have not done any heart stem cell implantations. I hate to be the first in this type of procedure. The other thing that troubles me is that the stem cells are released in an artery that leads to the heart. I am under the impression that direct injection into the unscarred heart tissue works better. I am still not ruling out XCell and Germany but I wonder if anyone knows of any Canadian facility that is doing clinical stem cell trials and do they take Americans. I understand that Canada is further advanced in their studies of stem cell treatment. Any thoughts you or anyone on this board has on this matter would be appreciated.
Bud

 

[barbara]

No help from the north

Harv may know something and I will let him answer. I do know that Dr. Fernandez is certainly doing a lot of work with cardiac patients. He is in Argentina. Communication is difficult unless you speak Spanish or know someone who could help you, but it could be worth your while to find someone to help you at least find out if treatment there is what you want. Unfortunately, I do not know of any treatment available in Canada unless it would be a clinical trial. They are in the same boat as the U.S. as far as stem cell therapy being able to be performed at this time for most applications.

 

[Buddy74]

Thank you for your input once again Harv. I really did not look at the Canadian venture as a good option having friends here in Florida who are from Canada. I am still pursuing some other options with regard to stem cells here in the U.S. and will keep this web site informed for input. Many thanks.
Bud

 

[hlichten]

Thank you for your input once again Harv. I really did not look at the Canadian venture as a good option having friends here in Florida who are from Canada. I am still pursuing some other options with regard to stem cells here in the U.S. and will keep this web site informed for input. Many thanks.
Bud

My pleasure.
Let me know how things progress for you.

 

[Erika's Mom]

Cardiac Trials

Another US location doing stem cell trials is Arizona Heart Institute, in conjunction with a company which makes a catheter system that allows direct injection of the cells (they are using skeletal muscle cells) into the inside of the heart.... see: http://www.advancedcell.com for some current news stories.