Common sense or the myth of unproven therapies and other scientific abracadabra
If you ask a doctor his opinion about stem cell therapy, he will immediately agree about the great potential and the revolution in medicine and get enthusiastic, the therapy of the future. At the same time if you ask him, get my child be treated now by you, he will start complaining about lack of placebo controlled studies, unproven, unsafe, safety has to established in the next decades, the mode of action is unknown, which cells we need exactly and so on. The main thing is to withhold people now cost what it cost from getting a new efficacious therapy with pseudo scientific arguments. There are many arguments to do so, ranging from true and honest attitude, but lack of knowledge to not invented here syndrome and not willing to lose a patient to another doctor, or even driven by anti stem cell lobbyists from various origin, but mainly instrumented not to lose current business.
Double blind placebo controlled dogma
I agree completely, a therapy must be safe and should bring good results in the majority of patients.
But double blind placebo controlled? Is that really the right thing to do? It means simply that a patient get the stem cells drawn, and he has a 50 percent change that he will be treated with the cells, the other half is treated with a n injection without cells. Do you want this for your child?
Do you have your child treated only for the sake of science? To have the professors increase their number of publications and their scientific impact? Is this really ethical to do?
My answer is a clear no, I would never do such a thing for my children. I know from what I am talking being a father a 4 lovely and thanks God healthy girls. I cant have my child suffering from anesthesia and a bone marrow , just to feed the scientific community……
Proven or speaking for itself?
What is proven therapy? I would say do the bloody obvious test and just look what the results are.
You will be surprised; stem cell therapy can do things no other therapy in the world is able to do.
Have you ever seen a drug, after which a child can speak, without doing it before the therapy?
I have not, never in my life, only after stem cells. What statical test should one apply to say that this result is statistically significant?
Have you seen a child not been able to move his legs and walking after getting a drug? After stem cells it is possible and I have seen it. I prefer not to do statistics in these cases, although I have learned it at university. We just did not learn what tests to apply in such cases, because such an improvement did not happen, never…..
Have you ever seen a child who was blind, to see again after administering a drug? You would say impossible, but with stem cells it is possible. Of course not in all children with vision problems it will happen, but it is reality in a vast majority of the children. What statistics do we need to prove this?
What statistical model and significance level we need to prove that the therapy is working?
I am a friend of speaking for itself results. It is not for nothing that people all around the world are coming to stem cell centers, they have made up their mind and also go for the bloody obvious test. Believe me, if you need sophisticated statistics to prove that your therapy works, forget it. The result will be so small, that you will not be happy with the end result. There is no clear cut obvious result. That is classical medical therapy, no clear obvious result. Of course there are obvious results in medicine, mainly in surgery. The indications for surgery have not been established by double blind trials, but by common sense. By the way in surgery double blind placebo controlled studies are in many circumstances just impossible, it is quit clear if somebody is in need of an amputation, you cant say now we don’t amputate, because of placebo……There are with drugs also obvious results for example with antibiotics. Within 2 days high fever can completely be reversed. It is on the other hand highly questionable why drugs are on the market s for for example multiple sclerosis. A highly statistical significant reduction of 1 point in the disease score allows a drug to get a marketing authorization. The best examples are the interferons, they show poor efficacy, lousy tolerability, in combination with a huge price.
The seed of uncertainty with regard to safety
Is the therapy really safe or is there may be a small chance that…….????
Nothing is more efficient to flourish as the semen of uncertainty. As soon as the first person has proclaimed a possible negative effect of stem cells, it is echoed everywhere without any rationale and scientific ground.
The illogical anti stem cell approach finds its climax in the request for toxicology and safety studies by health authorities. This strong attitude makes it virtually impossible to get a stem cell authorization in the next decades.
But let us consider it from the perspective of common sense.
What can be safer than your own cells? Your body lives in complete harmony with the bone marrow cells present in your bones. From time to time it delivers the cells to the bloodstream as it is supposed to do. Suddenly, as soon as you take it out of the body and concentrate it, it is proclaimed by scientists to be potentially toxic and cancerogenic.
In my opinion this way of thinking is erratic. Why should your own cell suddenly become toxic? This lacks every aspect of common sense…
Normally a drug must be tested in 2 species, a rat and another non rodent model. Autologous bone marrow, means that the cells are coming from the donor itself, so how would it be possible to test human cells in animals without damaging the unique concept of autologous transplant?
It is 2 steps back to test human cells in animals. Even if it might be feasible and immune reactions can be suppressed with medications or take an animal model without immune system, where is the common sense? It is like testing an airplane to drive on the road.
Stem cells from the bone marrow are since inception of the human being responsible for regenerating the human body. For example red blood cell are refreshed every 90 days by the hematopoietic stem cells from the bone marrow. Do we need to test the toxicology of this in an animal model? The same stem cells repair a wound after an injury, we have a quit good idea even how this works, although we are not 100 percent sure if we know the exact mode of action and the involvement of the exact cytokins and growth factors. Should we say, pls stop it, because we don’t know the exact mode of action? Stem cell therapy is the most safe and established therapy as it is practized in our body on a daily base. Only our scientists have made it to a problem, because they don’t understand the things. Nature understands it perfectly…….
Good or better?
Of course we have many questions which needs to be answered which cell type would be ultimately the best, is it bone marrow, or adipose tissue, or pluripotent stem cells or whatever cells? What is the most effective way of treatment, by intravenous route of directly in high concentration into the targeted organ? Do we need nano technology to deliver the cells to the site of injury? May be it would be better. May be in the next decade it would be available, may be not.
As with many things in life better is the enemy of good. By creating better therapies, we just forget the good therapy. May be expanded cells are better, but highly concentrated bone marrow is good.
May be a selection of CD133 cells is better, but highly concentrated bone marrow cells are good.
We have to make many improvements in the future and I am sure that in the next decade we might have a better therapy. But should this exclude the present patients to be excluded from the most natural therapy available nowadays?
Take it or leave it
Our life is nowadays concentrated on ourselves and is in some way egoistic. It is my life and I decide what to do. That ranges from buying the smart phone I want to decide what gender of partner I want.
Also in medicine it is my decision what I want to do, because it is my health. And I don’t want to wait for the next decades before we might have a better therapy or not.
I go even further, it is unethical to withheld a safe and efficacious therapy to thousands of patients.
So I would like to encourage you to make up your own mind, let you be informed by our team about the results and share our experience with clear cut effects and let you be convinced that our therapy is good and is available now for your child, not in the next decades, but now
With best personal regards
Dr Cornelis Kleinbloesem
Baarerstrasse 112 Zug Switzerland