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:

  • Controlling inflammation

  • Modulating the immune system

  • Stimulating regeneration

  • Reduce scarring

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 products 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:

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.

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:

  • 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

  • COPD/Respiratory disorders

  • Cardiovascular health/Heart Failure

  • Chronic Kidney Disease

  • Peripheral neuropathy

  • Autoimmune conditions: Multiple Sclerosis, IBD (Crohn’s disease/Ulcerative Colitis), Lupus, Rheumatoid arthritis

  • Erectile dysfunction

  • Autism

  • Diabetes

Is the cost 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.