Stem cell therapy successfully treats heart attack in animals

[Wise Young]

http://www.innovations-report.com/html/reports/life_sciences/report-47000.html

Stem cell therapy successfully treats heart attack in animals

Two patients enrolled in Phase I clinical trials at Hopkins

Final results of a study conducted at Johns Hopkins show that stem cell therapy can be used effectively to treat heart attacks, or myocardial infarction, in pigs. In just two months, stem cells harvested from another pig’s bone marrow and injected into the animal’s damaged heart restored heart function and repaired damaged heart muscle by 50 percent to 75 percent.

The Hopkins findings, first presented last fall at the 2004 Scientific Sessions of the American Heart Association, are to be published in the latest issue of the Proceedings of the National Academy of Sciences online the week of July 25.

Two patients have already been enrolled at Hopkins in a Phase I clinical trial, which is designed to test the safety of injecting adult stem cells at varying doses in patients who have recently suffered a heart attack. In total, 48 patients will participate in this study, which is happening at several sites across the country. Results are not expected until mid-2006.

[DA]

do you see the difference. animal to clinical trials, quick quick, snap snap, no time to sit around on a miami beach.

[richwelsh63]

Wise,
Dr. Kleinbloesem is also doing this treatment. www.cells4health.com
I don't know how many patients but he told me he is treating people that have had a heart attack. He uses the patients bone marrow.

[Lindox]

do you see the difference. animal to clinical trials, quick quick, snap snap, no time to sit around on a miami beach.

Pig to man. No wonder it went so fast.

[Wise Young]

Rich,

I posted more than two years ago on these forums the first German clinical trial reports indicating that bone marrow stem cell transfusions improve cardiac function after myocardial infarcts. This created great excitement and both animal and human trials have been proceeding in the United States. There have been reports from Texas and Pittsburgh of positive results in human trials of bone marrow cell treatments of myocardial infarcts and congestive heart failure.

Most of the clinical trials on bone marrow stem cell therapies of cardiac patients to date have been uncontrolled phase 1 and small phase 2 studies. Multicenter phase 3 trials are beginning. The animal studies showed that while the bone marrow stem cell therapies did improve function, the stem cells themselves did not produce new heart cells that replaced the ones that have been lost. Some studies have reported that bone marrow cells are fusing with cardiac cells instead of producing new cells. The conjecture is that the bone marrow cells may be producing growth factors that are accelerating healing of the heart. There has been a rush to find what factor(s) the bone marrow stem cells may be producing that is beneficial to the heart.

Because bone marrow stem cells are beneficial for the heart, it does not necessarily follow that the cells are also beneficial for chronic spinal cord injury. There have been animal studies suggesting that transplantation of bone marrow cells into the spinal cord stimulates remyelination of the spinal cord and improved locomotor recovery in rats. I summarized these studies in an earlier post on the subject. Kocsis, et al. (http://www.jneurosci.org/cgi/content/abstract/22/15/6623) have reported that bone marrow stem cells will form functional myelin when transplanted into demyelinated rat spinal cords.

In fact, bone marrow stem cells have been tried in both acute and chronic human spinal cord injury. I have posted repeatedly about some of these. For example, Tarcisio Barros' study in Brazil treated 34 chronic SCI patients with autologous bone marrow stem cells into the spinal cord. Vgrafen has posted several times about travelling to Brazil to partake in the trial. In China, in Zhengzhou, over 180 patients have received intrathecal administration of cultured CD44+ bone marrow stem cells shortly after injury. Darwin Prockop of Tulane has proposed and is trying to get a bone marrow stem cell transplant study going in the United States for the past two years.

There has been extensive discussion of bone marrow stem cell treatment of heart and spinal cord injury on these forums, too many for me to link. A search for "bone marrow heart" of this site will show 298 posts with those keywords. A search for "bone marrow spinal cord" will yield 478 posts with those keywords. I urge people to be cautious with respect to unpublished claims that bone marrow stem cells produce regeneration and improved function in chronic spinal cord injury. It is very important to know what cells are being transplanted and how they are being transplanted (whether they are infused systemically, injected intrathecally, or transplanted intraspinally).

We should remember the following:

1. Not all bone marrow "stem cells" are stem cells or beneficial for the spinal cord. Bone marrow has many kinds of cells and there are many ways to grow the cells and several animal studies have suggested that the effects of the bone marrow transplants depend on the kinds of the cells that are cultured.

2. Bone marrow cells may or may not penetrate across the blood brain barrier when infused intravenously. That is why some investigators have been giving the cells via other routes. Barros, for example, has been injecting the cells intra-arterially. The Zhengzhou group has been giving the cells intrathecally. I believe that the Prockop group is proposing to transplant the cells into the spinal cord directly.

3. There is no evidence yet that bone marrow stem cells are behaving like stem cells when they get into the spinal cord or that they are beneficial for chronic spinal cord injury. My colleague Ira Black has been transplanting bone marrow stem cells into the spinal cord of rats and they have not yet reported significant functional recovery and improvements associated with the transplant of the cells, particularly in chronic spinal cord injury.

Please understand that I am not putting down bone marrow stem cell therapies at all. I am excited by it but people should be cautious and understand what they are getting into. Some potential complications of bone marrow aspiration and infusions should be considered:

1. Bone marrow contains hematopoietic stem cells. It would not be good if transplanted cells were to produce red and white blood cells in the spinal cord. That is why it is important to know the identity of the cells that are being transplanted. For example, are they selecting CD44+ cells? Previous studies have shown that CD44+, collagen+, and fibronectin+ cells will remyelinate the spinal cord.

2. Bone marrow aspiration is not innocuous. Even in able-bodied people, it may cause some complications, such as transient anemia and local pain in the area of aspiration. In people with spinal cord injury, it may cause increased spasms and increased spasticity. In somebody with urinary tract infections, there is an increased risk of infections. http://www.emedicine.com/med/topic2971.htm

It is important that people understand the details of the therapy before they sign up for the therapy. Questions to ask include the following. How do they collect the cells? What are the cells that are being transplanted? How are they selecting and growing the cells? How are they transplanting the cells? What is the evidence that they are effective? How effective are they? What complications have occurred (infections, deaths, ascent of lesion)? How many patients have been done? How are they planning to treat complications?

Wise.

[Wise Young]

http://us.cnn.com/2005/HEALTH/07/26/stem.cells.heart.ap/index.html

Trials to test safety of stem cell therapy for heart damage

Tuesday, July 26, 2005; Posted: 11:21 a.m. EDT (15:21 GMT)

WASHINGTON (AP) -- A clinical trial to test the safety of treating heart attack damage with stem cells is about to get under way, following a study that showed the therapy helped in pigs.

Two patients have been enrolled so far at Johns Hopkins Hospital in Baltimore, and a total of 48 are expected to take part across the country, said Dr. Joshua M. Hare, who is leading the study.

"Anytime something new comes along there is a sense of excitement and that's the feeling that we have. And we obviously hope it will be borne out by the results," Hare said in a telephone interview.

The process uses adult stem cells taken from the bone marrow. These cells, called mesenchymal cells, have been shown to give rise to a variety of cell types. While they don't have the potential to develop into as many cell types as embryonic stem cells, using them avoids the controversy over taking cells from a human embryo.

[gretchen]

Dr. Young,

I appreciate your concern and I am grateful for everything you have done for our community.

I also understand that you are very busy, and that you cannot fly all over the world every time a new procedure is being experimented.

However, instead of raising serious questions on the website, couldn't you talk to Dr. Kleinbloesem in person? Hopefully, he would provide satisfying answers to your questions and would put your doubts to rest.

[Wise Young]

gretchen,

What bothers me is that they are not providing this information to people that are signed up to go to Turkey. I should not need to visit them to get this information. For example, what exactly are they doing? Will there be a laminectomy? Who is going to do it? What are they transplanting? How do they know? How many patients with spinal cord injury have been done? How much have they recovered? Have there been any complications? Has anybody posted how much this is costing them?

Despite all the discussions, I have not seen answers to these questions. All it takes is a detailed post or email describing the procedure and their experience to date. By the way, while I would be skeptical of answers like "all have recovered completely" and "there have been no complications", people should know from many years of my postings that I would not condemn the procedure if it did not work for everybody or causes some complications. Finally, why the secrecy?

Wise.

[richwelsh63]

gretchen,

What bothers me is that they are not providing this information to people that are signed up to go to Turkey. I should not need to visit them to get this information. For example, what exactly are they doing? Will there be a laminectomy? Who is going to do it? What are they transplanting? How do they know? How many patients with spinal cord injury have been done? How much have they recovered? Have there been any complications?


Wise.

Wise you raise very good questions and I forwarded them to Dr. k to see if he could answer them. He has not replied but here is what I know thus far:

What are they do?-Taking bone marrow stem cells from the patients hip and injecting them into the lesion.

Will their be a laminectomy? - Yes

What are they transplanting? - Bone marrow stem cells directly into the lesion above, below and into the lesion.

Who is going to do it? - A neurosurgeon

How do they know? how they know it's stem cells?? good question. you don't but what about any operation, how do you really know??

How many SCI have been done? - over 10

How much have they recovered? - Some are walking with and without assistance.

Have their been any complications? - No one has lost any function, no one has died, none that Dr. k has said.

I'm not trying to say this is the one. Dr. k needs to answer a lot of questions and their are many questions unanswered. I' personally have not signed up for this yet. First I'm going to go visit him and meet with patients, and see an operation. At that time my questions will get answered. Some CC members are signed up and ready to do it with out proof it works. That is scary but that is their decision. Hopefully we can get these questions answered soon.

[Wise Young]

Rich,

Let me try to specify what people should be asking. This is not like getting your car repaired and the parts are coming from the manufacturer.

• How and where will the cells be collected? I understand from Faye's posts that the bone marrow aspiration is being done in Germany. Is this what is being proposed. Who will be growing and processing the cells?
• How are the cells grown? Are they selecting CD44+ cells? This is supposed to be one of the markers for mesenchymal stem cells from bone marrow but this is still controversial. How long do they grow them? I presume that these are being grown in some facility in Germany. Who? Where? Are they certified as a good manufacturing practice (GMP) facility?
• How many cells will be transplanted? For example, one million or 15 million? How pure will the cells be? Will they be keeping any of the cells so that they can be analyzed afterwards? How do they know what is being grown?
• What is the transplantation procedure? Are they injecting the cells directly into the spinal cord? Will they be removing any part of the spinal cord? Are they doing a laminectomy and, if so, how big of a laminectomy? Are they opening the dura? If so, how will they repair the dura?
• Who is the neurosurgeon? I read that there was a neurosurgeon involved in Ankara but he is no longer being allowed to practice in one of the hospitals or something like that? They need to specify the surgeon and the hospital. What is the experience of the neurosurgeon?
• How are they doing the followup? What happens if people get complications such as wound infections, pain, ascending loss of neurological function, increasing spasticity, urinary tract infections, and other problems that are frequently associated with surgery. Who do people go to if they get postoperative problems after they have come home?
• How much is this procedure?
• What about followup rehabilitation?

These are simple common-sense questions and answers that people need to get before signing up for the procedure.

Wise.

[richwelsh63]

I'll try to get more specific answers. Thank You Wise. Your a great help. I'll be going in Sept if you want to come that would be great.

[Leif]

A little bit of my SCI history and discussions about loosing the rest of the functions we have:

I was diagnosed with an intraspinal AVM which is a tangle of blood vessels (a nest) in the thoracic region of my cord. - Basically it is a short cut of the arteries to the veins; they don’t go by the capillaries. It is a mess. Due to that the blood vessels will enlarge. This causes not only pressure to the spinal cord but also lack of nutrition etc. – Anyway this lesion did make me becoming worse and worse over time. Since the lesion was situated deep inside the cord the neurosurgeons and radiologists had serious problems to fix the problem. The reason was all the time that I could get worse. And they were very afraid to make me worse by an intervention.

The doctors first tried embolization and managed to fix a little part of the lesion. This was not enough because I continued to get worse. The surgeons here did not know what to do because of the nightmare it is for a neurosurgeon to go inside the cord. They don’t do it if they are not 100 % sure of what they are doing. After a while they sent me to Professor Pierre Lasjaunias at Centre Hospitalier de Bicetre in Paris, France. The surgeons there did another attempt for embolization. This attempt also failed because it was too risky to navigate inside the small arteries. - Professor Lasjaunias is world famous when it comes to embolization. And what does this tell us: It shows how dangerous it is to go inside a spinal cord even for doctors like this!!

Finally after a long waiting and considering time for and against surgery my Professor here at home got in contact with Professor Robert F. Spetzler in Arizona. This neurosurgeon and another neurosurgeon, Dr. Volker Sonntag agreed upon doing surgery. After a six hours surgery they managed to remove the AVM. It was fortunately a success as for the removal of the lesion and they managed to stop the negative trend I was in.

What I try to say here is that it is enormous dangerous to go inside a spinal cord if it is not life threatening. Like the surgeons I have been in contact with world wide there was only one that had the experience and the skill to do surgery on me. And when it comes to neurosurgeons Dr. Spetzler is considered to be one of the then best neurosurgeons, if not the best in the world. I urge everybody to think twice and carefully investigate any intervention procedure before deciding to have somebody go into a spinal cord.

Sorry for grammar or misspelling. I just wanted to tell peoples to be careful in the decision making process…and off course good luck.

Thanks Leif