Frequently Asked Questions
Regenerative Medicine FAQs
What are stem cells and exosomes?
Mesenchymal Stem Cells (MSCs), commonly referred to just as stem cells, are multipotent cells that have the ability to become more than one cell type. While they have this ability to change into other cell types, it’s their ability to secrete bioactive molecules that make them so amazing at healing our bodies. MSCs release proteins called growth factors, trophic factors, cytokines, chemokines, and exosomes.
MSCs work by:
Modulating the immune system
Exosomes are nanoparticle proteins secreted from stem cells (many cells secrete exosomes) in order to facilitate the healing capabilities of the surrounding cells. Exosomes induce progenitor stem cells to differentiate, so when injected locally or given intravenously they will deliver genetic material that tell surrounding cells to regenerate.
So simply put stem cells are a type of cell that produce medicine to heal other damaged cells and keep the environment around them balanced. They manage the bodies innate regenerative potential.
According to Arnold Caplan, PhD, considered to be the father of stem cell therapy since he discovered and named them Mesenchymal Stem Cells (MSCs). MSCs should more appropriately be named “Medicinal Signaling Cells” due to their most important function being the totality of secreted bioactive molecules.
“MSCs are multifactorial site-specific sensors with genetically wired molecular responses. MSCs see a signal and they respond in a controlled way. The MSC story will change the way medicine is practiced. Management of the patient’s innate regenerative resources will be the new treatment.” - Arnold Caplan
What kind of regenerative medicine products does Innate Healthcare use?
Stem cells and exosomes:
We use an umbilical cord tissue product called Wharton’s Jelly (WJ), the gelatinous layer found within the umbilical cord, which is obtained from healthy, consenting donors who are under the age of 35 and undergoing a scheduled c-section. The FDA strictly regulates the process of how these tissues are acquired, tested, processed and stored to ensure the highest level of patient safety. The exosomes are derived from MSCs from the WJ.
All recovery, processing, labeling and distribution is in accordance with Good Manufacturing Practices (cGMP) and Good Tissue Practices (cGTP), established by the US Food & Drug Administration (FDA). The product is prepared aseptically and supplied sterile. The manufacturing lab is registered with the FDA. The products do not require the traditional FDA drug approval. The products are exempt from the formal FDA drug approval process and are regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 The exemption criteria is set out in 21 CFR1271.10(a).
The product is minimally manipulated and intended for homologous use, as defined in US FDA requirements for Human Cellular and Tissue based Products (HCT/P), 21 CFR 1271, State regulations and guidelines of the American Association of Tissue Banks (AATB) and AABB.
This product is distributed ONLY to licensed health care professionals.
Platelet-Rich Plasma, PRP for short, is a regenerative procedure for joint pain, nerve pain, and can be used aesthetically. The procedure involves drawing typically 10-30n milliliters of the patients blood (About 1-2 tablespoons). Anticoagulant is added to the blood and it is spun in a centrifuge at a specific speed and time. During this process the red blood cells are separated from the the plasma portion of the whole blood and the platelets are concentrated. These concentrated platelets are then used for the treatment due to their innate healing abilities. Platelets provide the essential growth factors FGF, PDGF, TGF-ß, EGF, VEGF, and IGF that are involved in stem cell migration, differentiation and proliferation. The plasma is essential for cell survival as it contains nutrients, vitamins, hormones, electrolytes and proteins. Proteins are key molecules for the coagulation process and the formation of the fibrin polymer that will serve as a scaffold for cell migration, differentiation and proliferation.
While PRP can have a dozen or more growth factors the umbilical cord tissue/WJ can contain over 80 growth factors as well as an extensive amount of cytokines, mRNA, exosomes, secretomes and additional biologic elements including stem cells.
I’ve heard of bone marrow and adipose stem cell treatments. What is the difference between using stem cells from umbilical cord tissue and the other treatments?
Bone marrow and adipose derived stem cell therapies are viable treatment options for a few conditions, such as leukemia and joint pain. However as we age our stem cells decline in numbers and viability, their ability to heal and divide. So when trying to heal tissue we can a source that can provide a high number of young, healthy cells that are programed to heal and regenerate. Which is why our WJ and exosomes come from viable sources. That’s how we’re able to get such astounding results when applying proper dosages.
Another downside to these other treatments is the invasiveness. Both are procedures where the bone marrow or fat has to be removed from your body in surgical procedures, processed, and then injected back into you. This can be more painful, timely, and costly. The side effects of bruising and pain of these procedures can last for days to weeks.
What conditions can be treated with regenerative medicine therapies?
The conditions that can be treated with regenerative medicine is growing rapidly. The physician determines what conditions can safely be treated, and what kind or how much regenerative medicine would be clinically best for each patient. As with all other areas of medicine, we do not guarantee or claim that regenerative medicine/stem cell therapy will cure any disease. Our specific treatment protocols have NOT been evaluated by the FDA. Our treatments our guided by years of research and clinical experience to determine what will provide the best outcomes. Here’s some of the most common successful conditions we’ve treated:
All types of arthritis (Osteoarthritis has had great success)
Soft Tissue Conditions: Tendonitis, Bursitis, Ligament Injury (e.g. Achilles, Knee, Rotator Cuff)
Joint pain (Knee/Shoulder/Elbow/Ankle/Neck/Low Back pain
Autoimmune conditions: Multiple Sclerosis, IBD (Crohn’s disease/Ulcerative Colitis), Lupus, Rheumatoid arthritis
Cardiovascular health/Heart Failure
Chronic Kidney Disease
Sexual dysfunction for men and women (Erectile dysfunction, low arousal, orgasm disorder)
How is the medicine administered?
The medicine can be administered several ways:
Injected into a joint/muscle/nerve/tendon/ligament
Injected into the hair line and face for aesthetics. Or applied topically
Intravenously (Given into a vein, typically in the patients arm)
Intranasal (Delivered as a mist through the nose to better reach the brain)
Hand held nebulizer (Breathed in to treat the lungs)
Is the procedure covered under insurance?
At this time these procedures are not likely covered under any insurance plans.
What is the cost of a regenerative medicine procedure?
Procedures can range from $4,000 $20,000 + depending on what needs to be treated. We would like to point out that our dosages are 3 to 5 times higher than most clinics offering regenerative medicine treatments for thousands of dollars less than what other clinics charge. We’ve compared our costs to competitors and have found our rates to be as much as $10,000 or more less.
We don’t want cost to get in the way of you healthy so we have financing options and payment plans in place to get you on your way to being pain free and healthy!