Are Human Cellular Tissue products (i.e. “Stem cells”) FDA approved?

Are Human Cellular Tissue products FDA approved

Stem cells, or Wharton’s Jelly Allografts, or Human Cellular Tissue, all are the same thing. The FDA is not allowing the use of the term “stem cells” any more, so doctors are calling them all of these things.

No, these products are not FDA approved. The FDA says there is not enough research done on these products in order for them to be FDA approved. These products are regulated by the FDA. This means that the FDA has given guidelines that labs that sell these products to providers must follow.

Just because a product is not FDA approved, does not make it unsafe or dangerous. There are many products in the market that are not FDA approved. Nutrition and vitamins that you purchase regularly are likely not FDA approved. The FDA simply does not have the manpower to review every product that comes onto the market. That plus the amount of new products coming out regularly, creates an impossible situation for the FDA. They simply can not keep up. In some cases, yes, you should be wary of products that are not FDA approved. There are a lot of “snake oil” products out there, especially in the vitamin/nutrition arena. In the case of regenerative medicine, it is a different situation.

There are a lot of labs out there offering regenerative medicine products, so it is up to the doctor to find a trustworthy, reliable lab that provides a good product. Remember, the doctor administering the product is ultimately responsible and is putting his/her license on the line with every treatment they approve or administer. So, you should do your research and find a clinic that you feel comfortable with, one where you trust the doctor and the medical clinic administering the product.

We have been in the regenerative medicine field for almost 20 years, so we have seen and heard it all. The medical staff in our office has a combined experience of over 100 years in regenerative medicine! We have treated everyone from professional athletes to pre-teens, and have injected every body part imaginable with regenerative medicine products.

We also have done a lot of research on where we get our regenerative medicine products from. One of our labs has 13 government certifications, so if anyone in the military, NSA, DOD, etc. needs a regenerative medicine injection, they exclusively use this lab. We have access to this product and have seen great results with it. The other lab that we use participated in a study on “Wharton’s Jelly allografts” and was approved by Medicare. These two labs have gone through great lengths to get this recognition and to be trusted by the federal government and Medicare respectively. That is why we feel like our products are safe and effective. Yes, these regenerative medicine products are not FDA approved, but these are very good references none the less.

Where does Human Cellular Tissue (formerly known as “stem cells”) come from?

Where does Human Cellular Tissue come from

Stem cells, or Human Cellular Tissue or Wharton’s Jelly Allograft as they are now called, can come from several sources. They can come from you, or they can come from a donor. Stem cells can be drawn from a person from 2 areas. One is from your bone marrow. This is a surgical procedure. The doctor gets the bone marrow by drilling a hole in your bone, typically in the upper part of your leg, near your hip and extracting the bone marrow.

Then it is spun down in a centrifuge to separate the stem cells from other things in the bone marrow. There are pros and cons for this treatment, but there are more cons. The pro is that it is coming from you, so if you have concerns about where the stem cells are coming from, this eliminates that concern. There are quite a few cons:

  • Extracting the bone marrow is a surgical procedure. All surgical procedures come with risks, such as infection and a negative reaction to anesthesia. Also, surgical procedures are expensive, and since this treatment is not covered by insurance, it could be a large out of pocket expense, upwards of $15,000.
  • The quality and quantity of the cells extracted depends on the person. If you are older, so are your cells. Any accidents, injuries or illnesses that you have had throughout your life, your cells had them too.
  • The quantity of cells is also limited. The older you get, the less stem cells you have that are available to you.

The other source or stem cells is from your adipose fat. This is a less complicated procedure than bone marrow, but it is still invasive. The doctor extracts fat, typically from your belly region and spins that down to get the stem cells. This is not like liposuction, so you will not get skinnier from this procedure. This procedure was not recommended by the FDA because it was found that after a certain age, usually around 40, there are very few stem cells in adipose fat. So, if you are interested in doing this procedure, and you are over 40, you may not get a good result.

The last way to get stem cells is from a donor. Here’s how this process works. When a woman gets pregnant, her doctor may ask her if she would be willing to donate her afterbirth to a lab. If she agrees, then she is given a series of tests to ensure that her donated tissue is acceptable. The donor is checked for diseases, infections, genetic issues, and a slew of other things. If they pass all of these tests, then they get approved to be a donor. At the time of birth, a c-section is performed and the afterbirth (amniotic tissue, placenta and umbilical cord) are sent to a special lab.

Note that the mother and baby are not impacted in any way at all during this process. Back in the 1980s, there was some controversy about stem cells and that they were getting them from aborted fetuses. This was banned in the 1980s by the government and is illegal in the US. It was also found that these cells didn’t work well, so it’s a good thing they made them illegal.

Once the tissue is retrieved after the birthing process, it is quickly shipped to a regenerative medicine lab. These labs then will process the tissue and cryogenically store it until it is ordered by a doctor to be injected into a patient.

The highest concentration of stem cells is in the Wharton’s Jelly of the umbilical cord. That is why if the tissue is called “Wharton’s Jelly Allograft”, then it should contain stem cells.

The FDA is heavily involved in how this tissue is retrieved, stored and used. They require that it be “minimally manipulated”. This is just like it sounds. They don’t want the lab to make too many changes to the tissue. There are a lots of good things in this tissue, not just stem cells. There are growth factors, proteins and other materials that help the healing process.

There are some pros and cons to this option as well, however, the pros outweigh the cons in this case. This treatment is considered minimally invasive, meaning it is a simple injection. The risk is low, and assuming that the practitioner follows the FDA guidelines for an injection, the risk of infection is extremely low. There are no sedatives or anesthetics. We typically use an ethyl chloride “cold spray” to numb the area being injected. The patient has to “take it easy” for a few days after the injection, but that is about it.

As for the product being injected, it is very young and potent. The cells were preserved typically within a few hours of the time they were taken from the birthing process, so they are very good. Imagine having cells like the ones you had when you were an infant.

These cells are also considered “neutral”, in that they do not have to match a certain blood type, so they can be injected into anyone. Your body will accept these cells as if they were yours, so there is no risk of rejection.

The biggest con to this option is the cost. Human Tissue allografts can be expensive, costing anywhere from $4,000 to upwards of $12,000. It depends on the lab and the doctor’s fees. This is still less than the bone marrow aspirate option though.

Will Regenerative Medicine fix my problem?

Will Regenerative Medicine fix my problem

Human Cellular Tissue or Wharton’s Jelly Allografts (formerly known as “stem cells”) all refer to the same product and are used to treat a variety of health concerns. The most common are joint pain and neuropathy. As with all medical treatments, there is never a guarantee of results.

We have been treating patients using these products for over 20 years, and have seen great results. Our expectation is that a patient will get about a 50-60% improvement over their current condition. That is what we would consider a successful treatment. This result is achieved about 85% of the time in our office. However, we are selective on who we inject with these products. If the medical staff feels that using regenerative medicine will not be beneficial, we will tell the patient so. We will also do our best to explain the expected results from the treatment.

From our experience, we have seen human cellular tissue treatments do several things in a joint. Typically, the first thing we see is a reduction in inflammation and arthritis. Next, we see a reduction of pain. This may be due to a reduction of scar tissue in the joint or due to the reduction in inflammation. Finally, the last thing we have seen is a regeneration of tissue in the joint. This last step can take longer, sometimes taking 6 to 8 months or longer.

We have seen patients experience changes in their joint over several months, sometimes up to 8-12 months after their injection.

What types of regenerative medicine is there?

There are different types of regenerative medicine treatments. The ones we currently offer are:

The first four on the list, Human Cellular Tissue, Wharton’s Jelly Allograft, Amniotic Tissue Allograft and Nanoparticles are all sourced from a lab. The lab gets the tissue from donors. The tissue comes from the birthing process. The labs work with OBY/GYN doctors to screen potential donors for this tissue. They will check the donors health history, among many other tests to ensure that the tissue being donated is of exceptional quality. For example, some labs won’t take tissue from a donor that has a tattoo, for fear of toxicity due to the tattoo chemicals. That is how scrupulous they are.

The FDA has regulations for how this tissue is acquired and stored. There are guidelines that the labs need to follow. Some will try to exceed these guidelines. The labs also need to register the tissue with the US government. Every vial has a serial number, so it gets registered with the US Tissue Bank so they know where the tissue came from, and to whom it was given to. This is a similar process to what is done with other tissue donations, like hearts, kidneys, liver, etc.

Platelet Rich Plasma (“PRP”) comes from the patient. We draw one test tube of blood, or more, depending on the quantity needed for the treatment, and then spin it in a high speed centrifuge until the plasma separates from the red blood cells. You can see it is ready when you look at the test tube. On the bottom, you will see the accumulation of red blood cells, and on top is a liquid similar to the color of straw. That is the PRP. Typically, it takes about 15 minutes. The medical professional will draw up the PRP and use it for treatment. The rest is discarded.

Prolozone is created right in our office. We combine Traumeel, which is a natural anti-inflammatory, multivitamins and B-12 vitamins in a syringe. We then follow it up with an ozone injection. It can be done on any joint. This treatment is considered regenerative because it increases blood flow to the area.

Ozone is created right in our office as well. We have special equipment that creates medical grade ozone that can be used for a multitude of treatments.

Why won’t my primary care physician recommend regenerative medicine treatments?

primary care physician

There are several reasons why a primary care physician will not recommend regenerative medicine products. If a physician recommends that you get a treatment, they are putting their license on the line. Meaning if something goes bad, you can get that doctor in a lot of trouble, with malpractice lawsuits, complaints to the medical board, license suspensions, etc. That license is a physician’s lifeline and without it, he/she can not practice medicine. Any suspension or even a negative remark about them can be detrimental to their survival as a physician. Therefore, if that physician is not familiar with the product, they will not recommend it.

Same goes for recommending you get a treatment at a particular office. It’s the same scenario. If they are not familiar with that office, they will not put their license at risk by telling you it’s ok to go there.

Many physicians are not that familiar with regenerative medicine in general. They have a lot of new products, medications and treatments to keep up with, especially primary care physicians, and regenerative medicine is only now starting to get more popular. What most will tell you is to do your research, and choose someone you are comfortable with if you want to go that route.

Why does my insurance not cover regenerative medicine (i.e. “stem cells”)?

insurance not cover regenerative medicine

There are several opinions on why insurances are not covering regenerative medicine (i.e. “stem cells”) treatments. The first one you may hear is that because it is not FDA approved and considered “experimental”. Typically, the first to cover these types of new treatments would be Medicare. Once they approve it, then the other insurance companies follow suit. This is a safe approach because Medicare is very conservative and does a very good job studying a product before covering it.

They like to see the long term effects of the product as well, and they like to be in control of the studies for the product. Medicare typically does not accept third party data for making these types of decisions. So the first step that would need to be taken is for Medicare to start some studies to determine the effectiveness of regenerative medicine products like stem cells, wharton’s jelly allografts, amniotic tissue allografts, platelet rich plasma, etc. These take time, and then the data analysis that follows would also take time. We are not aware of any studies currently being done by Medicare, so it may still be a while before they are covered.

For those of you that like conspiracy theories, here is one that I have also heard about why insurances are not covering regenerative medicine treatments. This “theory” says that the medical industry, specifically pharmaceutical and surgeons are against these products being covered by insurance, and since they have pretty strong lobby organizations, they are holding up the approval from insurance companies.

The reason being that the pharmaceutical industry still has not figured out how they can make money on these types of products, so they are lobbying against it. Surgeons make a lot of money from performing a surgery. For example, a knee replacement surgery can cost anywhere from $50,000 to $70,000. The surgeon makes a lot of money from these types of surgeries.

If they had to give an injection that costs around 10% of that amount, they would be seeing a significant reduction in income, so they have their lobbyists also stopping their approval. How true this is, I don’t know, but that is a theory that I have heard.

Realistically, it is just a matter of time before regenerative medicine is covered by insurances. These products are growing in popularity, and the FDA and other government organizations are looking at them much more closely than they were 5-10 years ago. That is a good sign, and hopefully some day they will be covered. In the mean time, we can all take solace in knowing that due to all this increased attention, the products that are on the market are getting better and safer.

How long will it take for me to see a result with Human Tissue Allografts (formerly known as “Stem Cells”)?

Human Tissue Allografts

The time it takes to see a result is unique for every person. We have had patients that notice changes in 2-3 weeks, and others have taken months before they noticed a change. There are too many variables to predict how soon a patient will see a result. Age, severity of degeneration, overall health and many other factors come into play.

One thing we can say is that these products always work, so long as they are good quality, live cells. The only way they do not work is if the cells injected were damaged or dead. We have had many patients come into our clinic saying they tried “stem cells” and they didn’t work. Most of the time, they can not tell us what lab these cells came from or even what quantity they received.

Regenerative medicine is very much a “buyer beware” situation, and there are a lot of clinics out there jumping on the bandwagon, buying not good products and then selling them to patients for a lot of money. Unless you have tons of money to just throw away, you should always do due diligence on the doctor’s office and the product you are getting injected, whether it’s human cellular tissue or any other product, for that matter.

Another reason why a patient may not get the anticipated result from an injection of human cellular tissue is that they may have gone to other parts of the body and fixed those first, which is why you didn’t feel the result in the area that got treated. Unfortunately, once the cells are injected into your body, we don’t have any control over where they will go. Your body controls that. These cells tend to go to areas of inflammation, since that is typically where the injuries are.

For some joints that are encapsulated, like a knee or shoulder, we can safely assume that a majority will stay in that joint, but some will go to your heart, lungs and digestive system as well. For parts of the body that are not encapsulated, such as low back/sacroiliac joint or along the facets, these areas are not encapsulated, so the cells will enter your blood stream and travel to other parts of your body.

The other common reason why a patient did not get the result they were anticipating is that there were simply not enough cells to get the job done and you need more. If a certain amount left the injection area, as I mentioned above, and the degeneration in the area being treated is severe, then it’s possible that there just was not enough product to get the job done. The solution here is to get more human cellular tissue injected in that area.