Stem cells are cells that create all other cells in the human body. They reproduce to generate daughter cells or specialized cells. Daughter cells eventually become new stem cells, while specialized cells have a specific function other than creating new stem cells. These specialized cells can become blood cells, brain cells, heart muscle cells, or any other cells in the body. Stem cells are the only cell in the body with the natural ability to spawn new cell types.
There are several types of stem cells:
Embryonic stem cells: These stem cells from embryos are three to five days old and can either reproduce into more stem cells or become a specialized cell type. This versatility allows them to regenerate or repair diseased tissues or organs.
Adult stem cells: These are typically found in adult tissues, such as bone marrow or fat. They have a more limited function and versatility than embryonic stem cells but may create other types of cells.
Perinatal stem cells: These originate from perinatal tissues typically discarded at birth, such as the placenta, umbilical cord, cord blood, and amniotic fluid.
Induced pluripotent stem cells: Scientists create these cells by genetically altering adult stem cells to act like embryonic stem cells. This newer technique remains under heavy investigation to determine its effectiveness in stem cell therapy.
Researchers continue using stem cells to:
Understand how diseases occur and progress
Test new medications and non-surgical treatment options for safety and effectiveness before administering the treatment to human subjects during clinical trials
Generate healthy cells to replace diseased cells, which is known as regenerative medicine
Stem cell therapy is a regenerative medication application of stem cells in which stem cells or their derivatives are injected into diseased, dysfunctional, or injured tissues to repair them. This therapy utilizes the body’s natural healing mechanisms to reduce inflammation and encourage healing for medical conditions with few effective treatment options.
Research on stem cell therapy and exosome treatment is still ongoing, with few therapies having FDA approval. Exosomes are extracellular vesicles released from cells that allow for intercellular communication. They transport genetic information and proteins to other cells. Exosomes also inform other cells how and when to react to stimuli. Stem cell therapy and exosome treatments are currently heralded as the next frontier of cell therapy and regenerative medicine despite lacking approval from the FDA.
FDA Approval and Warnings
The FDA has not approved any exosome products or therapies, and the only stem cell-based products with FDA approval are those using blood-forming stem cells derived from cord blood. The FDA approved this use of stem cells in limited use for patients with disorders affecting the production of blood.
If your healthcare professional suggests stem cell therapy for your medical condition, ensure the offered treatment is FDA-approved or studied in the Investigational New Drug Application (INDA). INDA treatments have FDA approval, as they are clinical trials for new therapies. INDA treatments are also subject to FDA and Institutional Review Board (IRB) supervision and review. The IRB is a group designed to review and monitor biomedical research using human subjects. Before a clinical trial begins recruiting human test subjects, IRB must approve of the study and will require researchers to continually modify their study to ensure it remains safe and ethical at every stage.
You may view the complete list of FDA-approved licensed products for stem cell therapy here.
Researchers will continue to study stem cell therapy before it can become a viable treatment option. Stem cell therapy can be a life-changing therapy for many patients, but it is not currently an approved therapy option. Many organizations offer stem cell therapies that lack FDA approval and are not part of FDA or INDA clinical trials. Your insurance company may not cover this treatment option, as it is still considered an experimental treatment option.
Some types of cancer and blood-related diseases
Leukemia, lymphoma, neuroblastoma, and multiple myeloma
While more research is needed, stem cell therapy possesses the ability to treat any disease. As researchers continue to study stem cells, the list of potential benefits of this treatment option will grow.
Stem cells provide researchers the opportunity to study how diseases work and experiment with various new treatment options without needing to test directly on human subjects. This can help increase the effectiveness of new treatment options before they reach the human subject phase of clinical trials.
The procedure for stem cell therapy may depend on who performs the therapy. Clinical trials may experiment with new procedures under FDA and international Review Board (IRB) guidance, while FDA-approved procedures typically have a set procedure. You can learn more by visiting the FDA’s website on clinical trials, available here.
When trying a stem cell therapy application currently not FDA-approved, your risks include:
Short or long-term complications in the form of health issues or exacerbating your condition
May include death, severe infection, tumors
Potential for contamination of stem cells
Cells may move from placement sites and multiple or change into inappropriate cell types
Being barred from future clinical trials or treatment options for your participation in an unproven or experimental treatment not part of INDA
When participating in an FDA-approved stem cell therapy application, your risks include:
Potential rejection of transplanted stem cells
Infection, bleeding, or bruising at the injection site
Stem cell therapy not providing the desired result