29 Oct The Risk Benefit Analysis of Mesenchymal Stem Cell Therapy
Over the past eight years, R3 Stem Cells’ Centers of Excellence in the US, Mexico and Pakistan have administered over 15,000 stem cell and exosome procedures. With eight years of experience and over 15 IRB Approved protocols, R3 Stem Cell’s Centers are trusted by patients and utilize safe biologics that come from FDA Regulated labs.
Quite a few procedures our Centers perform result from referrals of friends and family along with repeat procedures desired by patients after receiving amazing results. This is a direct result of a very high patient satisfaction rate!
One of the questions patients ask often to our providers is “Are these procedures safe? What are the side effects?” What patients really want to know are the potential complications associated with stem cell therapies.
In order to answer that, a few clarifications need to be made first. These include:
- Stem Cells Being Used
One of the common myths patients have is that the stem cells being used come from aborted fetuses. This is NOT true at all. The types of stem cells that are derived from that source would be Embryonic Stem Cells.
Embryonic Stem Cells should NOT be used in clinical circumstances until a considerable amount of additional research is completed. They can cause considerable problems such as rejection and/or tumors. R3’s Centers domestically and internationally have NEVER used Embryonic stem cells! We only use mesenchymal and hematopoietic stem cells.
- Source of the Stem Cells
There are six potential sources of stem cells, only three of which are actually used clinically. These can include sources from the patient him/herself, which is known as autologous. Or the source can be from a donor, which is known as an allograft.
When the cells come from the patient (autograft), the tissue is either from fat tissue (adipose) or from the bone marrow. The harvesting involves a somewhat invasive procedure for each, which I’ll discuss below.
If the cells come from a donor, the one acceptable source is from what’s called post-natal tissue. This includes the placenta, umbilical cord and amniotic fluid which is obtained after a scheduled c-section. There is no harm to baby or mother.
The three sources of cells that are NOT USED CLINICALLY at any of our Centers are from aborted fetuses, left over IVF embryos, or what’s called induced pluripotent stem cells (iPSC’s). While these may be used in some countries, they have considerable safety issues, complication potential, and should be AVOIDED big time. If anyone suggests you should consider an embryonic stem cell procedure, RUN AWAY!
- Quality Assurance
In the world of stem cell therapy, a lot of the “magic” happens at the lab. Not only does this refer to the composition of the biologic with regard to stem cells, growth factors, cytokines, exosomes, but also the quality assurances in place.
The FDA regulates labs quite stringently in the US. This includes regulations on donor programs, tissue processing, disease testing, storage and transport. FDA inspection visits occur regularly at labs to ensure they are maintaining proper safety protocols.
Complications and Side Effects
With an autograft treatment including adipose, the fat is harvested from the patient him/herself. So the issue of rejection is moot. The procedure itself includes harvesting the fat from either the abdomen or the area at the top of the buttock. Different body type typically determines where the physician will perform the liposuction.
The harvesting procedure can possibly lead to discomfort for 1-2 weeks, but usually just a few days. Bruising is common, and you may have some small drainage from the wound. There is a very small chance of infection from the procedure.
In rare circumstances, a physician may puncture the bowel or cause a fat embolism. I’ve never heard of that happening in reality for a fat harvesting with stem cell therapy, since, the amount removed is only about 60 cc’s. But it could according to the literature. There could also be an allergic reaction to the numbing medicine used, which is also incredibly unusual.
Additional factors come into play depending on how one’s adipose tissue is processed. While not the focus of this article, there are some differences between techniques such as SVF vs. SVT. If an adipose stem cell therapy were to be performed intravenously, a filter should be used to prevent an embolism. For an injection procedure, no filter is needed.
All in all, adipose stem cell therapy harvesting tends to be very well tolerated and safe.
When it comes to bone marrow procedures, a physician will harvest the marrow from a patient’s iliac crest. The needle used is about the size of a ball point pen. In order to make the procedure tolerable, the physician will either numb the area big time, or perform sedation.
The potential complications from a bone marrow harvesting include excessive bleeding, especially in a patient with low platelets or taking blood thinners. Also, an infection may occur. Up to 40% of patients experience chronic pain from the procedure. Why? The iliac crest is an incredibly sensitive area, and it doesn’t appreciate a large needle being stuck into it. So chronic pain for months may occur.
Unusual complications from an iliac crest bone marrow harvest may include issues that result from the needle falling off the iliac crest. If this occurs, any nearby structure can be damaged such as bowel, blood vessels or nerves. While rare, there are plenty of reports in the literature about it.
When it comes to allograft donor tissue from the placenta, amniotic fluid, and umbilical cord, there are also a few complications that may occur. Thankfully, the incidence of them is extremely low.
To clarify again, the complications and side effects mentioned here do NOT include embryonic stem cells or iPSC’s. Those may cause rejection or tumors, and R3’s Centers have never used those. So we’re only discussing mesenchymal and hematopoietic stem cell tissues.
One of the main questions patients ask is, “Can I reject the tissue since it’s coming from an unrelated donor?” The answer is no. Post-natal tissue has stem cells that are called “immunologically privileged” by scientists. This means they are “naive” and do not elicit a formal rejection reaction in the recipient. In over 15,000 procedures performed to date at R3’s Centers, we have never seen a rejection reaction!
When umbilical cord blood is used, one would think that cross matching of blood would be necessary. In fact, research has shown that not to be the case. Once again, it has to do with the fact that cells from post-natal tissue are “naïve”, and have not mounted mature MHC characteristics to initiate a significant immune reaction in the recipient. This means no cross matching is necessary.
The biologics themselves typically contain a preservative. This is most commonly DMSO, which stands for dimethyl sulfoxide. As you may surmise, this does contain a small amount of sulphur. In theory, it could cause an allergic reaction in a patient who has a sulfa allergy. The amount of sulphur is REALLY low, so it’s very rarely an issue. However, there is a biologic with a glycerol preservative that may be used. The use of glycerol instead of sulphur has not affected stem cell viability. Also, R3 does have one stem cell biologic that does not contain a preservative at all. So that is an option as well.
Any time an allograft is used, there is a theoretical potential for a disease transmission. All of the biologics used at R3’s Centers come from labs that are either FDA Regulated or have standards that exceed those of the FDA. This means a large amount of testing for many diseases, including Hepatitis, HIV, Chagas, etc. Also bacteria are tested for and while test results are pending, the biologics stay in a quarantine freezer for two weeks. We have not seen a disease transmission to date.
There has been an instance of contamination at a lab by one of the preservatives several years ago. R3 Stem Cell has never dealt with the lab. The bacterial contamination led to deep infectons in over a dozen patients, and a recall was initiated. This did NOT occur at any of R3’s Centers.
As with autograft procedures, allograft procedures also have a potential for an infection. In eight years, R3’s Centers have not seen a deep infection. There have been minor cases of cellulitis, which resolved with an oral antibiotic. This too is rare.
There are many studies looking at whether mesenchymal or hematopoetic stem cells can lead to a tumor. The answer is NO. The stem cells from post-natal tissue are nontumorigenic, and this has been shown over and over again. There are even several studies showing that the cells can inhibit tumor formation and/or progression. Having stated that, R3 does NOT offer cancer treatments with stem cells.
The typical side effects seen with an allograft stem cell procedure are minor and temporary. We have seen low grade fever, lightheadedness, slight chills or possibly discomfort at the injection site. These side effects typically resolve overnight.
Thankfully, allograft stem cell procedures with amniotic and/or umbilical cord tissue have been exceptionally safe. At R3 Stem Cell International, this has included intrathecal administration in addition to IV, intranasal, injection and nebulizer too.
In conclusion, autograft and allograft stem cell procedures have been shown to be remarkably safe with minor complications typically being reported.