Stem cell research used to be controversial specifically because of the attention given to embryonic stem cells, which are derived from human embryos. Thankfully, very little research is done on embryonic stem cells anymore, because there are now better, non-controversial alternatives available for research and clinical use. These alternatives include induced pluripotent stem cells (derived from mature human cells) and adult stem cells, which can be sourced from the blood, bone marrow, and fat tissue, for example.
For this reason, the overwhelming majority of Americans now support stem cell research. The percentage of people who have moral issues with stem cells has been on the decline since 2002.
In place of the old controversy, though, a new one has arisen. Instead of worrying about ethics, scientists and health care professionals now stress about the safety and efficacy of unproven stem cell procedures. Today’s controversial topic is how stem cells should be regulated by the U.S. FDA and other regulatory agencies worldwide.
How to Assess Stem Cell Procedures
Are you considering stem cell therapy? If so, you will need to know the difference between a proven stem cell procedure and one that’s out to take your money. While this article cannot provide medical advice, below you will leave seven tactical tips for how to assess whether a stem cell procedure is safe and legal, so that you can do your part to keep yourself safe.
1. Consider the Different Types of Stem Cells
There are several different types of stem cells, including:
- embryonic
- adult stem cells
- tissue-specific stem cells
- induced pluripotent stem cells
Embryonic stem cells are only found in early-stage embryos. They come from the hollow ball of cells (the blastocyst) that forms 3–5 days after gestation (when sperm fertilizes an egg). Embryonic is the ideal type of stem cell because it can give rise to any type of cell in the human body.
Adult stem cells are stem cells derived from human beings without harming them. While these cells are called “adult” stem cells, they are present in newborns, children and adults. Mesenchymal stem cells (MSCs) are one of the most common types of adult stem cells. MSCs are often called stroma stem cells because they come from stroma (the connective tissue that protects organs). You may have heard of them, because they are commonly used in many types of orthopedic procedures.
Hematopoietic stem cells (HSCs) are another type of adult stem cell found in abundant quantities within newborn umbilical cord blood, as well as adult peripheral blood and bone marrow. Both HSCs and MSCs have been used in the form of bone marrow transplants since the first one was completed in 1956.
Meanwhile, tissue-specific stem cells are as they sound— they only develop into cells of the same type. For example, a liver-specific stem cell will give rise to other liver cells, never a heart cell or a brain cell. Similarly, cardiac stem cells will differentiate into the cells of the heart. This puts limitations on the use of tissue-specific stem cell therapies.
Since their discovery in 2006, scientists have also been able to create induced pluripotent stem (iPS) cells. These cells are made using a laboratory process that “reverse engineers” the cells back into a pluripotent state. iPSs are similar to embryonic stem cells, in that they can become any of the 200 cell types that create a human being.
2. What are the Potential Applications of Stem Cell Therapy?
As you just learned, stem cells are unique because they can turn into different cells in the body. Diseases tend to have negative effects on cells. That’s why researchers think stem cells have the potential to treat diseases.
Scientists can use stem cells to grow new organs or tissues for transplants. In the same vein, researchers want to use stem cells to regenerate damaged tissues inside the body.
Other studies have utilized stem cells to replace genetically defective cells. Research into diseases is easier when we have stem cells to test on. Plus, stem cells may be useful when studying new pharmaceuticals or even vaccines.
3. What Stem Cell Procedures are FDA approved?
There are few approved treatments that use stem cells. So far, the U.S. FDA has approved only 16 cell and gene therapy products. Of these, only half (8 of the 16) are stem cell treatments and all of these are derived from umbilical cord blood.
Approved stem cell treatments include: ALLOCORD, CLEVECORD, HEMACORD, and Ducord, as well as four hematopoietic progenitor cell (HPC) products, developed by Clinimmune Labs, MD Anderson Cord Blood Bank, LifeSouth Community Blood Centers, and Bloodworks, respectively.
As stated by the FDA, “The only stem cell-based products that are FDA-approved for use in the U.S. consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood.”
In addition to these FDA approved therapies, a diverse range of stem cell therapies are being offered directly to patients. Over the past five years, the number of physicians offering stem cell treatments has expanded exponentially.
These services include, but are not limited to, treatments involving stem cells derived from bone marrow, adipose tissue, or peripheral blood, as well as cells derived from umbilical cord blood and tissue, placental blood and tissue, and amniotic fluid and tissue.
4. Know Which Stem Cell Procedures are Effective
Just because stem cells have the potential to treat disease and more doesn’t mean we know for certain that they can do so. Only a few types of stem cell procedures are practiced by doctors today, many of which are unregulated and/or unapproved.
These stem cell procedures include:
- Grafts
- Bone marrow transplants
- IV infusions
- Injections
Grafts or implanted tissues have shown promise in treating injuries of the bone, skin, and eyes. Bone marrow and blood transplants are more extensively researched and practiced. Some stem cell procedures are also approved for treating certain types of cancer.
5. Companies Offer Untested Stem Cell Procedures
Are you considering a stem cell procedure at a clinic near you? Even if you have nothing to lose, we recommend you read this warning first.
Any organization outside of a hospital, medical practice, or verified health care institution should not be administering stem cell treatments. Keep in mind that experimental treatments do not mean you’ll be involved in a clinical trial.
Additionally, unproven stem cell procedures may cause more harm than good. They could lead to health complications. That’s not to mention the financial burden of paying for these unapproved procedures out of pocket.
Before you take any action, review this FDA warning about stem cell procedures.
6. How Unregulated Stem Cell Procedures Work
If you choose to have an unproven stem cell procedure done anyway, here’s what you can expect.
Many clinics offer intravenous (IV) stem cell treatments in which the administrator infuses stem cells into your bloodstream. Some clinics offer site injections to target specific tissues. There are also intrathecal injections, which go directly into your spinal cord.
Clinics that market these services most commonly use mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs). If you recall, these stem cells are only approved for use in bone marrow and blood transplants.
These clinics claim that stem cell therapy may exert positive effects, such as:
- replacing damaged cells
- limiting inflation
- reducing fibrosis (scarring)
- positively impacting other cells types within the micro-environment (the site of injury)
- creating a healthy immune response
In some cases, same day, autologous (self-derived), unmanipulated stem cell procedures can be allowed within the United States. This happens when a procedure gets categorized as “361 product.”
Put simply, this means that the stem cell procedure does not have to be regulated as a “drug and/or biologic” by the U.S. FDA. Thus, it can be administered by a physician to a patient without FDA oversight.
7. What is an Autologous Stem Cell Transplant?
Clinics that offer unproven stem cell treatments are often offering autologous transplants.
Autologous transplants utilize stem cells from your own body. Clinic administrators then inject your own stem cells back into your body. Depending on the level of professionalism at the clinic, there are a number of risks autologous transplants confer. These include:
- The potential of viral, bacterial, or pathogenic contamination
- The potential of damaging manipulation occurring to the cells
- Injecting autologous stem cells in the wrong place could lead to yet unknown future complications
If you do plan to get an unproven stem cell therapy, speak to your primary care team (or other qualified experts) about whether the procedure is right—and safe—for you.
Are Stem Cell Procedures Right for You?
Did your doctor recommend one of the small number of stem cell procedures that are FDA approved? If so, you can rest assured that you’re getting an relatively safe, effective, and well-tested treatment.
For other types stem cell procedures, don’t proceed unless you make sure they are performed by a reputable and experienced physician, are appropriately classified as a 361 product (not requiring FDA approval), and are administered by a team who has been tracking patient registry data over a long-period of time.
This is important, because the procedure may not have gone through rigorous medical research.
Do you have questions about stem cell treatment procedures? If so, you can ask an experienced stem cell treatment provider here.
Disclaimer: Statements made in this article are NOT expressed as medical claims or advice. They are not intended to diagnose, treat, cure or prevent any disease or condition. If you have a health condition or concern, consult your physician or health care provider.