The stem cell procedures performed at our clinics are in compliance with CFR 21 Part 1271 same surgery exemption discussed in 1271.15 (b).
For detailed information, visit these links:
- Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry (PDF – 79KB)
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff (PDF – 198KB)
Cells are the building blocks of living things. The human body is composed of trillions of cells. They provide structure for the body, take in nutrients from food, convert those nutrients into energy, and carry out specialized functions. Cells also contain the body’s hereditary material and can make copies of themselves. Cells are comprised of many parts, each with a different function.
A stem cell is unique because of its ability to turn into any type of cell in your body. It can divide, multiply, renew, and regenerate. These cells don’t carry out specialized functions like brain, red, or white blood cells, but they are the most vital component in repairing and replacing damaged or torn tissue. They are the essential building blocks of life.
No, there are a number of different types of stem cells, which come from two main sources:
- Embryos formed during embryological development (embryonic stem cells)
- Adult tissue (adult stem cells).
Both have potential to differentiate into different cell types (such as skin, muscle, bone, etc.).
Stem cells are categorized by their potential to differentiate into other types of cells. Embryonic stem cells are the most potent since they must become every type of cell in the body.
- Totipotent – the ability to differentiate into all possible cell types. Examples are the zygote formed at egg fertilization and the first few cells that result from the division of the zygote.
- Pluripotent – the ability to differentiate into almost all cell types. Examples include embryonic stem cells and cells that are derived from the mesoderm, endoderm, and ectoderm germ layers that are formed in the beginning stages of embryonic stem cell differentiation.
- Multipotent – the ability to differentiate into a closely related family of cells. Examples include hematopoietic (adult) stem cells that can become red and white blood cells or platelets.
Orthopedic stem cell treatments are relatively new, so there is not enough evidence to rule out a small chance of this possibility. However, after hundreds of thousands of procedures performed using patients own cells, there is no evidence to suggest this is a common occurrence. Medical procedures do come with risks, such as infections or autoimmune response. MSC’s or Mesenchymal Stem Cells, with limited multipotency, are less likely to produce risk of cancer than undifferentiated embryonic cells or induced pluripotent stem cells with their pluripotency.
The goal for stem cell therapy is to use healthy stem cells found in the body to replace or activate your body’s own stem cells at an injured site. When you have damaged tissue anywhere in your body, the damaged tissue signals to your body’s own stem cells. Unfortunately, as you age, the number of stem cells in your body significantly decreases and the potency of those stem cells also decreases, which can result in a dramatic decrease in your healing ability.
Stem Cell Therapy introduces large amounts of regenerative factors to the injured tissue to substantially increase your body’s healing potential and ability. This injection of stem cells and various other growth factors is believed to activate your body’s own stem cells to start healing the injured tissue. The stem cells may be harvested from the patient or from a donor. Once they have been safely extracted, they are reinjected back into the body to rebuild properly functioning tissues.
Stem Cell Treatments are offered around the world, in locations that have different regulations than those found in the United States. The FDA allows these procedures in the United States under a same-day surgical procedure provision, but with many rules around the processing and sourcing of the cells. Other countries may have limited or no regulations, or may allow stem cell processing or delivery techniques that are not allowed in the United States at this time.
Stem Cell research is ongoing and is one of the most promising possibilities for treating diseases in the future. Research is already proving that cellular treatments deserve a place in the treatment of orthopedic conditions and many doctors believe that the majority of invasive surgeries that take place today, will be replaced with new forms of cellular treatments designed to restore damaged tissues, rather than removing them in surgical procedures.
Stem Cell Treatments for orthopedic conditions are relatively low risk, due to the fact that the cells come from your own body. No medical procedures are without risk, but the risks are largely limited to those of other injection procedures. If stem cell treatment is recommended for you, the doctor will explain the procedure and outline any potential complications that may result from the treatment.
The National Institute of Health website has many resources available around clinical trials, research, the FDA and more.