ARE YOUR STEM CELL TREATMENTS IN THE USA FDA APPROVED?
Yes. In the US we perform sterile injection of bone marrow aspirate, which contains stem cells, into affected joints, not intravenously, for musculoskeletal problems in accordance with FDA guidelines. The sterile aspirate is not manipulated, is injected at the same procedure as the aspiration, for homologous use. We do not perform any other stem cell procedure in the United States.
HOW ABOUT YOUR FAT GRAFT INJECTIONS?
We harvest a small amount of fat in the office and inject it into affected joints, not as a stem cell procedure but rather for its cushioning effects. We wash it, gently centrifuge it, and size it in a closed system using sterile technique in a sterile laminar air flow hood in accordance with FDA guidelines. This tissue is minimally manipulated, injected at the same procedure, for homologous use: again according to FDA guidelines.
TREATMENTS IN ANTIGUA AND ATHENS GREECE
These countries have their own regulatory bodies rather than the FDA, which is operational in the United States. Our stem cell injections there are performed in full compliance with the rules of their regulatory bodies.
What are Mesenchymal Stem Cells?
- Partially differentiated stem cells that are active in tissue repair. They help tissues heal themselves. They modulate the immune system and decrease inflammation.
- They are NOT fetal or embryonic
What Are Stem Cells Injections Used for?
- Arthritic joints as an alternative to joint replacement
- Neurologic diseases such as MS and Parkinson’s disease
- Inflammatory bowel disease: ulcerative colitis and Crohn’s Disease
- Rheumatoid Arthritis and Lupus
- Spinal cord injury and post stroke
- Psoriasis and other skin disorders
- Pulmonary fibrosis and COPD
- Erectile dysfunction, Peyronie’s disease and interstitial cystitis
- Lyme Disease
- Chronic Fatigue
- Spinal disorders
- Any auto-immune or inflammatory disorder
How Effective are Stem Cells for These disorders
- Results vary by disease. For some disorders they are very effective. For others at this time their effect may be small or only effective early in the disease. For arthritis most patients are treated successfully and are able to avoid joint replacement surgery.
How Many Treatments Are Needed?
- For many disorders 1 treatment will last for years. In some cases treatment must be repeated more often.
How Long Does It Take for Treatment to Work?
- Results are usually seen within days.
Are there any Diseases Where Stem Cells have not been shown to work so far
- Yes, at this writing in September 2020, in general genetic disorders such as cystic fibrosis, huntington’s chorea and Duchenne muscular dystrophy are not benefitted. Although stem cell treatment combined with gene editing shows great promiser for the future. There has also been little to no success with Alzheimer’s Disease.
Autologous versus Allogeneic
What Do Autolgous and Allogeneic Mean?
- Autologous means it comes from the patient being treated
- Allogeneic means it comes from someone else
Do You Use Autologous or Allogeneic Cells?
- We use both. Specifically we use autologous stem cells from fat, or occasionally bone marrow from the given patient. We also use allogeneic cultured umbilical cord cells.
Are There Risks/complications of Mesenchymal Stem Cell Injections
Stem cell treatment is arguably one of the safest treatment paradigms that exists. There are no medication side effects and no surgical complications. We have completed a systematic literature review submitted for publication showing no severe adverse events ever reported for stem cell treatment for arthritis for example. There is a theoretical risk of infection anytime an injection takes place although we have never seen one,. Stem cell injections are actually used to help fight infections. Minor side effects such as transient local pain, light headedness may be seen.
Can I Be Treated With Stem Cells if I Am on Blood Thinners or Other Medicines?
- Yes, patients should maintain all prior medications stem cell treatment. Coumadin or other blood thinners are not a problem.
Mechanism of action
How Do Autologous Mesenchymal Stem Cells Work?
- Via growth factors that help your tissue heal (eg transforming growth factor beta), platelet derived growth factor).
- Also via anti-inflammatory cytokines that fight inflammation. Their mechanism of action is immunomodulation. For example they can help modulate your macrophage cells away from the M1 pro-inflammatory state to the M2 anti-inflammatory pro-healing state.
- There is new evidence that mesenchymal stem cells take root and live after they are injected and keep working long after the injection.
Who Does the Actual Injection in Your Clinic?
- All injections are done by Dr. Prodromos, (or by Dr. Hatz DDS for TMJ injections)
- We do not have mid-level practitioners performing the injections as is the case at many clinics
Do You Inject Using Ultrasound?
- Yes, where needed. This allows precise placement and no use of X-rays in the vast majority of injections
Do You Use Sedation or Medications?
- None are used, none are needed. In fact we avoid them to eliminate possible medication side effects
Are the Injections Painful?
- Injections in joints have some discomfort but it is minimal and usually far less than patients expect. Many patients are often surprised that the injection has been completed so easily. IV injections have no pain or other side effects in general. Occasionally a patient will feel transiently flushed or light headed.