What are stem cells and why do we hear so much about them?

Stem cells help to create new cells in existing healthy tissues, and may help repair tissues in areas that are injured or damaged. They are the basis for the specific cell types that make up each organ in the body. Stem cells are distinguished from other cells by a few important characteristics: they have the ability to self-renew; they have the ability to divide for a long period of time; and, under certain conditions, they can be induced to differentiate into specialized cells with distinct functions (phenotypes) including, but not limited to, cardiac cells, liver cells, fat cells, bone cells, cartilage cells, nerve cells, and connective tissue cells. The ability of cells to differentiate into a variety of other cells is termed multipotency. What scientists learn about controlling stem cell differentiation can become the basis for new treatments of many serious diseases and injuries.

Where do the stem cells come from?

Stem cells can be derived from various sources, including adult tissues (such as bone marrow and adipose tissue), embryos, and umbilical cord blood. Adult stem cells, also known as tissue-specific stem cells, are found in specific tissues and are generally difficult to grow and expand in the laboratory. Hematopoietic or blood-forming stem cells in the bone marrow, for example, only make up one in a hundred thousand cells of the bone marrow but can be isolated and used in treatments like bone marrow transplants.

Why are doctors and scientists so excited about stem cells?

Stem cells have potential in many different areas of health and medical research.

• Studying stem cells will help us to understand how stem cells transform into the array of specialized cells that make up the human body. Some of the most serious medical conditions, such as cancer and birth defects, may result from problems that occur in this process of differentiation. A better understanding of normal cell development will allow us to understand and perhaps correct the errors that cause these medical conditions.

• Stem cells will provide a tool for pharmacologic development. Stem cell research should allow the development of cell populations with a specific disease. These cell populations can then be used for initial testing with candidate drugs.

• Finally, perhaps the most exciting potential application of stem cells is cell therapy. Pluripotent stem cells offer the possibility of a renewable source of replacement cells and possibly tissues to treat a myriad of diseases, conditions, and disabilities including Parkinson's disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

What is stem cell therapy?

"Stem cell therapy” more accurately termed as “cell-based therapies” since the procedures we use do not have “true stem cells” that can differentiate into any tissue, has been under intensive study for the last few decades.  Virtually every field of medicine is exploring its use. Essentially, we are harnessing the power of cells – the “building blocks” of all the cells in your body – to regenerate and repair tissue. This field of medicine – regenerative medicine – is revolutionary. Instead of giving you a foreign chemical (i.e. medication) or putting in a plastic-and-metal joint replacement, we are utilizing your body’s fundamental repair mechanisms and directing them to the site that needs the most attention. It is perhaps one of the most “natural” treatments we can provide in Medicine.

Why do you use bone marrow cells?

Bone marrow cells are easily obtained. They can be processed with minimal manipulation, per FDA guidelines. But most importantly, they are closer in cell lineage to cartilage and tendon than fat cells. That means they have less to differentiate (change) to become the cells we need them to. Finally, there are many more clinical studies documenting the efficacy of bone marrow-derived cells as compared to adipose cells.

What is the difference between embryonic and adult stem cells?

Some organs contain stem cells, called adult stem cells, that persist throughout life and contribute to the maintenance and repair of those organs. Not every organ has been shown to contain these cells, and generally, adult stem cells have restricted developmental potential, meaning their capacity for proliferation is limited and they can give rise only to a few cell types. Embryonic stem cells, by contrast, can divide almost indefinitely and can give rise to every cell type in the body, suggesting that they may be the most versatile source of cells for research and transplantation therapy. Note: We do not use embryonic stem cells at STEMS Health Florida.

How are stem cells obtained?

Adult stem cells are most commonly obtained from the outside part of the pelvis, the iliac crest. A needle is inserted in the iliac bone and bone marrow is withdrawn or aspirated through the needle. Several samples may be obtained from one area in this manner. The stem cells may then be separated from other cells in the marrow and grown or expanded in the laboratory. This may take from 7 to 21 days. When stem cells are placed in a specific tissue environment, such as bone, they become activated. As they divide, they create new stem cells and second generation, progenitor cells. It is the progenitor cells which may differentiate into newer cells with the same phenotype as the host tissue.

What are the risks of injecting stem cells or exosomes? What are potential side effects?

The risks and potential side effects of injecting stem cells or exosomes include:

• The ability of cells to move from placement sites and change into inappropriate cell types or multiply

• Failure of cells to work as expected

• The growth of tumors

• Risk of contamination if cells are manipulated after removal

• Administration site reactions

• Infection

• Allergic reactions

• Cross-reactivity reaction

Even if stem cells are your own, there are still safety risks, including those mentioned above see FDA warning here).

How do the stem cells work to reduce my pain and heal my injury?

Stem cells work to reduce pain and heal injuries by differentiating into the specialized cells required for repairing damaged tissues. This process involves identifying, isolating, and growing the right kind of stem cell, then developing the right conditions so that the cells differentiate into the specialized cells needed for a particular treatment. This approach aims to replace diseased cells with healthy ones, a process similar to organ transplantation but with cells instead of organs.

What are the best stem cells?

The "best" stem cells depend on the specific application or condition being treated. For some conditions, adult stem cells, such as hematopoietic stem cells from bone marrow, are effective and have been used for decades in treatments like bone marrow transplants. Induced pluripotent stem cells (iPS cells), which are adult cells engineered to become pluripotent, also hold significant promise due to their ability to form all cell types of the body and potential for patient-specific therapies.

Are stem cells safe and/or legal? What is the literature/data behind stem cells?

Stem cell treatments that are FDA-approved or being studied under an Investigational New Drug Application (IND) are considered legal and have undergone rigorous testing for safety and efficacy. However, many stem cell treatments offered by clinics worldwide are unproven and unregulated, posing significant safety risks to patients. The FDA has taken action against unapproved stem cell products and clinics offering such treatments. The scientific literature supports the potential of stem cells in treating a wide range of conditions, but also emphasizes the need for further research to establish their safety and effectiveness.

The FDA has established a division to regulate blood products, known as the Center for Biologics Evaluation and Research. Under regulation 21 CFR 1271.15(b), treatment using a patient’s own blood products is allowed by the FDA. Numerous devices that prepare PRP have been FDA cleared. Cell therapy, if utilizing a patient’s own cells, and if those cells are “minimally manipulated” is also allowed by the FDA. The FDA still considers these treatments to be investigational.

Are stem cell treatments safe?

Stem cell treatments are minimally invasive compared to other surgeries, and their safety and efficacy continue to be studied. We do know that, when managed properly and in proper conditions, stem cell therapy is generally safe, but like all medical treatments, do possess potential dangers. Potential dangers include:

• As stem cells renew themselves and can become different kinds of cells, they might become cancer cells and form tumors.

• Stem cells grown in the laboratory, or adult cells reprogrammed to be stem cells, might have genetic damage.

The safety of stem cell treatments hinges on numerous factors, including the source of the stem cells, the method of extraction, and the delivery technique. Procedures like liposuction or spinal tap, which are sometimes employed to harvest stem cells, or the methods used to implant them into the heart, brain, spinal cord, or other organs, carry their own set of risks, not directly related to the stem cells but to the procedures themselves. Like all medical interventions, stem cell treatments come with inherent risks, with clinical trials aiming to assess if the potential benefits outweigh these risks. One significant concern is the risk of tumor or cancer development, especially if the cells undergo excessive growth in culture, known as expansion, losing the natural mechanisms that regulate their growth. Pluripotent stem cells, for instance, carry a risk of forming tumors known as teratomas if they remain undifferentiated. We can gauard against this by testing stem cells prior to utilizing them in treatment. Other potential risks include infection, tissue rejection, and complications related to the medical procedure itself.