Installment 65 - Ask the Doctor with Dr Todd K. Malan

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Jeannine

Pioneer Founding member
About Dr Todd K. Malan
Dr. Todd K. Malan is considered a pioneer of stem cell therapy in the U.S.
In October 2009, Dr Malan was the first physician to begin utilizing fat derived stem cells for studies in the U.S.
As a Board Certified cosmetic surgeon, those studies which focused on cosmetic and reconstructive procedures, lead to anecdotal improvement of patients with CNS, autoimmune, neuropathy, and joint disease.
Dr. Malan began sharing his experiences with Doctors world wide through his many lectures, text books, and physician training courses.
This lead to a gathering of physicians from multiple specialties determined to combine efforts to advance stem cell research in the U.S. in a safe and ethical manner.
The IRB approved safety study for fat derived stem cell therapies is one of many studies Dr. Malan is involved in here in the U.S. and abroad.
Dr. Malan is the only U.S. Physician to own both the Cytori and Maxstem stem cell processing devices which have proven greater live cell numbers over manual processing. Dr. Malan can be contacted via his website: http://www.mystemcelltherapy.com or Phone: (480) 998-7999


Q: I am just beginning to learn about stem cell therapy. There are some that seem to think more stem cells are better and others that feel that quality and type over quantity is better. How do you feel about this issue? I think it is natural to think more is better, but I understand that this might not always be the case.
A: Great question. Did you know that the only reason we use antibiotics for 10 days is due to the original studies being done on prisoners and the researchers only being allowed to visit study prisoners once every 10 days. Many things we do in medicine are not evidence based but more so on clinical intuition or on observational evidence. The original studies done on stem cells used a total count of 5 million.
Now this is a tricky thing to explain as we aren't referring to just true stem cells but stromal vascular fraction (SVF) which contains stem cells along with the "building blocks" (other cell types) which the stem cells need to build and repair. So, in these studies they selected 5 million as this is an average count from 1cc of concentrated SVF. Those studies also did not measure the cells viability. So is 30 million better than 5 million? A lot depends on methods used for counting.
Well we do know that live is better than dead and sadly many centers don't have the resources to invest in quality automated cell counting equipment and use the inaccurate manual counts with a microscope. This manual method will not tell you what is alive or dead and will create errors when they mistakenly count cells larger than 60 microns which are not SVF.
If every one used the accurate methods of counting that we use the it would be possible to answer this question someday but frankly we don't know.
In my studies we measure not just total cell counts but also measure cell viability. I exclude all cells less than 10 microns or larger than 60 microns from the measure sample.
I have "observed" that 5 million live cells is sufficient for a site specific injection as in injecting directly into a damaged knee. However for systemic (IV) injections we know that approx 30% of cells get trapped in the lungs and heart. That's not necessarily bad it's just what happens. In addition we can't control the order of preference in which stem cells will be attracted to an area of needed repair. For example, If I treated a Parkinson's patient who had coincidentally broken a rib a few days before the treatment with over 25 million live cells, many of those cells could be "used up" trying to heal the rib which the body senses as being the more acute problem. A similar case has happened and required a second treatment before the Parkinson's improved whereas 25 million live cells is usually plenty.
My clinical intuition is that for joints, 5 million is more than enough if they actually are all living cells. For IV treatments, I prefer 15-30 million at the least and 50-75 million as an ideal. Anything above that does not seem to make a difference. There are always exceptions however such as the lupus patient with multiple organs affected.

Q: Does having high stem cell counts of 200 million stem cells improve results for treating conditions such as MS and peripheral neuropathy?
A: This questio is of a similar nature as answered above. Sadly once our U.S. Study was approved, the for profit foreign stem cell treatment centers such as Mexico, Caribbean, and Asia started a campaign of trying to convince patients that they would get better results over seas as they would be using larger numbers of stem cells. Prior to our being "competition" these overseas centers were fine with 5 million as the standard. My other issue with these centers is there is no oversight. They could simply be making up numbers to convince patients that what they offer is some how better. We use an automated cell counting devices that records all study patients results and that only measure living cells that are truly SVF. We have not seen that greater than 50 million is of any benefit and most patients do well with as little as 5 million. Knowing the time and cost involved in processing more than 50 million I simply do not believe the numbers these for profit stem cell clinics are claiming nor do I feel its necessary.

Q: Have you had success in treating peripheral neuropathy? How long does it take for the nerves to regenerate?
A: In October 2009, I performed the first human fat derived stem cell treatment in the U.S.
The patient had previously had a major portion of his right buttock damaged due to a traumatic injury that occurred during the Vietnam war. The goal of my treatment was simply to fill in the missing tissue of his buttock with fat that had been enriched with stem cells to increase the fat graft survival much as they had been doing for years in Japan with breast reconstruction patients following mastectomy. Besides the missing tissue he also suffered from foot drop due to nerve damage. Again this was an injury 45 years old. When he came back at 6 weeks not only was his buttock perfectly shaped but he could move is foot normally! ( I usually hate exclamation points but it fits here)
The nerve had regenerated. With most of our neuropathy patients who have a pain component, we see immediate relief of pain followed by increasing motor and sensory function over the next 6-12 weeks. After 12 weeks some function continues to improve but the "wow" changes are the first 12 weeks.
This was not a study patient and I must make a disclaimer that these results may have been coincidental.

Q: I have chronic inflammatory demylinating polyneuropathy with secondary axonal degeneration which began in January, 2011. I can't stand up without a walker. The foot drops. Have you had a case like this before? If so, what is the best protocol?
A: Yes we have treated similar patients. Few however as this is a rare condition. Please be aware that our study is a safety study and as such we can not share specific outcomes as that is not the permitted goal of our study. I can generalize by saying that as of today 12/3/13, every stem cell treatment we have done has resulted in improvement and without any serious side effects.

Q: Are embryonic stem cells given in the Ukraine and China better than mesenchymal cells? What about antigens?
A: Embryonic stem cells are a gimmick. These cells are very effective at rebuilding bone marrow stem cells but little else unless manipulated which posses unknown risks.
Thus far only non manipulated fat derived stem cells have shown the capacity to do more than just differentiate. Differentiation means changing form one cell type to another. Non manipulated bone marrow stem cells do this but little else. Why is that an issue?
When we first started using fat derived stem cells, which are far more plentiful then bone marrow, we learned some amazing secrets that they held. When I inject a damaged heart muscle with bone marrow stem cells, the bone marrow stem cells can differentiate to replace damaged muscle and that's it.
However when I use fat, the fat stem cells are able to realize that the real problem isn't the dead heart muscle but the lack of oxygen from clogged blood vessels that caused the damage to the heart muscle. The fat stem cells will enter the area and force the damaged cells into hibernation. They will then alter the physiology such that the heart is not working as hard, then start growing a new blood supply to replace the poor supply, then wake the heart muscle cells from hibernation and finally replace any which do not perk up now that new oxygen is available. Fat derived stem cells are like tiny doctors who can fix the real problem and they don't complain as much as real ones. (This is based on animal model and the European RESTORE trail)

Q: What disease/condition are you having the most success with? Do you find that most patients require multiple treatments for most conditions?
A: Unfortunately I am not allowed to give detailed information on success. This is a safety study and the outcomes we are measuring is supposed to be safety only. Giving potential study participants subjective patient results would be unfair as it may influence someone to sign up for a study in which the risks are unknown. In addition certain governmental organizations and their pharmaceutical company lobbyists would love to see me make that mistake.
Again as a generalization and as of 12/3/13, all of my study participants have shown improvement in whatever conditions they presented with and no significant risks but we have a long way to go before we can make promises or give percentages. We are using the patients own cells to heal the body. I have observed that the mind body interaction and faith is very powerful in this process.

Q: Does your clinic use a computerized device that views and counts the stem cells? I was told by a representative of an offshore clinic that no U.S. clinics have that technology.
A: That's another great lie from the for profit off shore clinics. Yes I use an unfortunately expensive computerized system that not only counts cells but separates out real SVF from debri and can differentiate between live and dead cells.

Q: I was informed that a doctor is conducting a placental stem cell clinical trial by CT injection for pudendal neuropathy. How do adipose stem cells compare to placental stem cells in treating this pelvic neuropathic condition?
See answer to number 4.

A: That doctor is using growth hormones in an effort to force those cells to do the job that fat does naturally. Frankly I think that is foolish. I have seen doctors try this and cause bone to form in the skin or muscle instead of nerve. I feel it's much smarter to simply concentrate the cells, deliver them to area in need of repair, and let them work as intended.
Why are companies and even major hospitals using bone marrow stem cells that were shown 20 years ago to not be very effective? Because companies are using gimmicks such as "activating" the stem cells with chemicals or even lasers and are willing to spend millions on research. Why are they willing to spend millions on this and not just un modified fat?
They can't make a profit off of your unmodified fat stem cells but if they are able to make bone marrow stem cells that have not done well un-modified work after modification then they can have a patent and potential profit.

Q: Do you work with any offshore companies if a patient would need advanced type stem cell treatments (expanded cells) that cannot be performed in the U.S.?
A: Yes I do work with a truly reputable U.S. owned stem cell hospital in the Bahamas.

Q: Can stem cell therapy be used to kill cancer cells? I am not talking about leukemia treatments, but I recently read that a cancer patient with advanced melanoma had stem cell treatment and now the disease is gone.
A: This is not only controversial but proven in the lab to be dangerous. Studies done at Univ of Penn showed that cancer cells which were dormant due to radiation or chemo therapy treatment were not activated and in some cases were "killed" by adding stem cells to the culture. However when added to cultures in which cancer cells were actively growing, the stem cells enhanced the growth. Stem cells should not be considered a treatment for acute cancer but perhaps may be shown to be beneficial following initial remission.

Q: After treatment, how long should a patient expect to feel any kind of improvement and is it more generally gradual rather than something significant all at once? I know some people get upset if they don't feel anything in a few days after being treated, but I have also read that it can take 2-3 months before any change occurs.
A: This is the most common question that causes a great many phone calls after treatment. Many conditions we treat have some degree of inflammatory, hormonal, or neurotransmitter related cause to their symptoms. Often within hours of the stem cell injection these symptoms will dramatically improve.
As an example (only as again I can't share specifics), let's say a patient has Parkinson's in which they have symptoms based on low dopamine levels or a chronic pain patient who's pain is made much worse due to high levels of inflammatory cytokines. The stem cells determine what is going on and try to fix any immediate issues so that brain of the Parkinson's patients may see a burst of dopamine and the chronic pain patient may see cytokines levels drop. The patients calls that night and believes I am a miracle worker. However true repair of damaged tissue take weeks not hours so over the next few days the apparent miracle seems to be going away and I so now I get a panicked phone call. Usually however within a few days the patients settle back into a new "baseline" which is better than they were before treatment. Then over the next weeks and months they see the changes that occur from true repair of damage or disease process.
 
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