The 6 Exact Steps to Today’s Stem Cell Therapy


In the U.S., Modern Stem Cell Therapy Must Meet Exacting Standards

Today’s stem cell therapy has opened new worlds of wellness and potential across the globe. Here in the United States, a particular type of stem cell and a minimally invasive procedure that meets FDA guidelines have revolutionized the face of regenerative medicine. This is not to say that stem cell research has waned. Far from it. New discoveries in stem cell therapy are being made practically on a daily basis.

But not all stem cell types are the same. And not all stem cell clinics, even in the United States, practice the most effective procedures or use the most potent and versatile types. One of the objectives of the National Stem Cell Institute (NSI) is to educate the public about today’s stem cell therapy.

NSI is one of the leading stem cell clinics based in the U.S. So the Institute has a vested interest in keeping people informed about what makes a stem cell therapy legitimate, and what is actually “snake oil” under the guise of safe, effective stem cell treatment.

So Let’s Begin with a Brief Overview of Stem Cell Therapy Basics

Our bodies are made up of over 200 distinct types of cells. All of these types arise during the development phase in pregnancy that is known as the zygote stage. This stage is the very core of physical being, in which all cell types needed by the body come into existence.

Every cell type of the body takes on a size and structure that makes it suitable for its work. For example, nerve cells have long, branching fibers while skin cells are small and compact. Cells with functions in common form the tissues of the body. The tissues, in turn, coalesce to form organs. Meanwhile every cell that makes up the tissue has a specific task. When the cells that make up a specific type of tissue or organ work in concert while carrying out their individually “assigned” tasks, everything functions well.

No matter the size or structure, every single cell in the human body begins its life with the following components in common.

  1. The Nucleus. This structure within a cell holds the body’s DNA. Think of DNA as a genetic library. It informs the cells about their role. Cells “read” the DNA and perform duties according to the instructions encoded there. It is these instructions that determine someone’s eye or hair color, blood type, and can even determine how vulnerable someone is to disease, just to name a few.
  2. The Cytoplasm. This is the vicious, liquid layer that envelops the nucleus. Suspended within the cytoplasm is an assortment of components that allow the cell to perform its duties.
  3. The Cell Membrane. This is the cell’s “skin.” It is a complex layer that does much more than just house the elements of the cell. The cell membrane also sends and receives the signals emitted by neighboring cells. Additionally, it is the “gate keeper” of the cell, allowing the passage of materials into and out of the cell. It is this function of the membrane that enables cells to communicate with one another.
  4. Cell division. Virtually all of the body’s cells replicate themselves by dividing. When cells divide, the result is known as two “daughter” cells. Just before dividing, the DNA within the original cell replicates. This means that each daughter cell contains a complete copy of the DNA. The new cells are perfect copies of the original.

How Stem Cells Differ from Fully Mature Cells

Stem cells are characterized by two elements:

  • Stem cells can either replicate or self-renew.
  • Stem cells are undifferentiated. In other words, they have not yet been “assigned” a cell function.

Stem cells vary in versatility, depending on where they originate within the body. The two primary types of stem cells used in medicine are:

  • Pluripotent stem cells can generate every cell type of the body except those needed to develop a fetus. For a variety of reasons, naturally occurring pluripotent stem cells are rarely used in practical stem cell therapy.
  • When a stem cell type is classified as multipotent it means that the cells are capable of generating a wide variety of different types of body cells, though not quite as many types as the pluripotent kind. Nevertheless, multipotent stem cells have such an impressive range that they are the primary type used in the United States for stem cell therapy.

Stem cells underpin the repair and rejuvenation of every organ and tissue in the body. Each stem cell, regardless of type, has the ability to self-renew and differentiate into specialized cells. In most stem cell research, all stem cell types are used. However, in practical stem cell therapy application with patients, it is the multipotent adult stem cell that has caused a revolution in how medicine is being practiced.

How Multipotent Mesenchymal Stem Cells are Used in Stem Cell Therapy

Mesenchymal stem cells (MSCs) are those that are stored in the connective material that surrounds the body’s tissues and organs. MSCs were first discovered in bone marrow. When it was proven that these MSCs could regenerate bone, cartilage, and fat cells the beginning of modern stem cell therapy came into being.

Since then, they have been grown from other tissues, such as fat and cord blood. MSCs are multipotent and are now being used in the U.S. as stem cell therapy in an ever-growing list of diseases, injuries, and disorders. Those conducting stem cell research by and large agree that not all types of mesenchymal stem cells have the same degree of effectiveness.

The potency and versatility of MSCs depend on where they originate within the body, how they are isolated, and how they are manipulated in the medical lab.

To develop various types of stem cell therapy, the MSCs must be manipulated under laboratory conditions. This is because stem cells left in their original locations throughout the body don’t spontaneously transform into cells needed for another location. For example, blood stem cells will only give rise to blood cells. They will not differentiate into brain cells on their own. They must be processed under laboratory conditions if they are to become a viable stem cell therapy capable of addressing other areas of disease or injury.

The development of stem cell therapy is a multi-step process. Decades of meticulous stem cell research has culminated in a procedure that is FDA guidelines compliant and can be done within a few hours on an outpatient basis. The procedure uses adipose fat-derived MSCs, which are stem cells harvested from the patient’s fatty tissue that lies just beneath the skin.

Because adipose-derived stem cells are especially abundant and highly potent, only a very small sample of fat tissue is needed.

This makes stem cell therapy procedures done with adipose MSCs very minimally invasive and far better tolerated by the patient, hence the ability to perform therapy within a few hours in an outpatient clinical setting. The discovery and development of adipose-derived MSCs has revolutionized stem cell therapy.

Today, adipose-derived stem cell therapy performed under exacting FDA guidelines has opened up a world of real and practical procedures that are minimally invasive and hold the minimum risk of infection or allergic reaction. There is also inherently low-to-no risk of rejection because the stem cells used are the patients’ own.

Adipose-derived stem cell therapy available to the public include therapies for:

The Scientific Method Behind Stem Cell Therapy

Today’s stem cell therapy procedures could not have been developed safely and effectively without sound medical science. Stem cell research has, and still does, undergo the same rigorous procedures as all things medically related.

Every stem cell therapy available to the U.S. public has gone through the 6 essential steps of the scientific method.

Listed out, the steps seem deceptively simple:

  • Pose a question
  • Conduct thorough background research
  • Create a hypothesis based on the evidence of that research
  • Test the hypothesis in an objective way that will either prove or disprove it
  • Expose the results to rigorous analysis
  • Make a conclusion based on the testing and analysis

Simple though each step may seem they are highly effective, and so time-tested that they are the bedrock upon which all science and medical research stand. But another critical element stem cell research (and all scientific research, for that matter) is replication and external (also known as peer) review.

Replication is the ability to repeat the results of the tests. It is essential; however, that replication isn’t just successfully done by the research team who has made the conclusion. Before any medical procedure becomes a practical, real-world reality for patients, it must come under the scrutiny of experts unattached to the study. This is as true for stem cell therapy. In this way, medical experts have traditionally collaborated with and built upon the innovations of peers.

How Stem Cell Therapy is Approved for Use

Virtually every developed nation has an established review agency that scrutinizes the conclusions of the clinical research. These agencies help to ensure that procedures like stem cell therapy is safe and effective before the therapies are green-lighted for public exposure. Every country has its own rules, regulations, and procedures for carrying this out. But they all have this end-game in mind: medical treatments such as stem cell therapy are regulated to ensure that health claims are not made that have not been proven through the trial process.

Even so, it is worth noting that the science of stem cell therapy is relatively new (taken into context with most medical developments). And not all nations are as rigorous in their testing as the United States. This leaves the door open to vulnerable patients who leave the country in a desperate bid to undergo poorly researched stem cell therapy in other parts of the world.

Often, they are seeking a stem cell therapy that is not yet proven –or doesn’t actually yet exist- for their particular illness or disorder. This leaves them vulnerable to unscrupulous people who sell false hope for top dollar.

The FDA is currently the federal administration most relied on for guidance by the public in the U.S.

In the United States, for the time being, it is the Food and Drug Administration (FDA) that most of the public relies on for advice about stem cell therapy. Contrary to popular belief, the FDA does not regulate stem cell therapy or stem cell research. However, the FDA can and does issue guidelines regarding the medical manipulation of stem cells. Any legitimate stem cell clinic operating in the United States adheres to these FDA guidelines.

The Future of Stem Cell Therapy

Stem cell therapy is no longer a “someday” scenario. There is an impressive number of therapies that are already in use in the United States, and the list is continually growing. Meanwhile, stem cell research continues in a wide range of studies including:

  • Alzheimer’s disease
  • Amyotrophic lateral sclerosis (ALS)
  • Autism
  • Stroke
  • Kidney disease
  • Liver disease

Stem cell therapy is truly one of modern science’s most remarkable medical developments. But it is important to remember that stem cell therapy –as with any modern medical methods- is not a “magic bullet.” It is also crucial for patients seeking stem cell therapy to be aware that this new and developing field of medicine can be misrepresented by unscrupulous, unlicensed actors.

Stem cell therapy, as is the case with all legitimate medical procedures in the United States, must be performed by a trained and licensed physician. Regenerative medicine clinics, commonly referred to as stem cell clinics that perform stem cell therapy in the U.S. must be in compliance with current FDA guidelines.

With this in mind, the National Stem Cell Institute (NSI) cautions those seeking treatment to beware of stem cell therapies offered without FDA guidelines compliance or outside the confines of a legitimate stem cell clinic. Below are tips on what to look for in a licensed, legally operating stem cell clinic. Those with questions are encouraged to contact NSI.

What to Look for in a Stem Cell Medical Clinic












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