Regenerative Medicine Frequently Asked Questions

Stem Cell Therapy and RejuvaWAVE ® Shockwave Therapy Questions:

1. What is Regenerative Medicine?  

Regenerative Medicine is the NEW emerging field of medicine that focuses on harnessing your body's own healing potential to repair, regenerate and renew diseased and injured tissues such as tendons, connective tissues, joints, ligaments, cartilage, bone, blood vessels and nerves.

 Regenerative therapies focus on stimulating your body's own regenerative powers to heal injured tissue and reverse chronic diseases, auto immune conditions, and age-related degeneration such as arthritis, neuropathy, neurological conditions and erectile dysfunction. Traditional medicine offers only a "band aid" approach to mask the condition while the underlying disease and age-related conditions continue to progress.

Regenerative Medicine treats the underlying cause and shifts the body into a 100% healing state.  Regenerative Medicine at REJUVAnation Medical Center is cutting-edge and combines amniotic and umbilical allograft stem cell activating therapies, Exosomes, Platelet Rich Plasma (PRP), and the revolutionary RejuvaWAVE® to spur the body’s natural healing processes.  


2. What is a Stem Cell?

Stem cells are specialized cells within our body that have the potential to replicate and to grow into any one of more than 200 cells types, tissues, and organs found in the body.  They are our body's master cells like a blank slate,  Dr. Arnold Caplan, a researcher at Case Western Reserve University and the father of modern stem cell therapy, has shown that stem cells work by migrating to sites of injury and disease and secreting signals telling the body "to get to work and repair itself." They receive "signals" from their environment which direct them along which "pathway" and what type of tissue to turn into and help our body to renew and repair throughout our life.  But as we age the ability of these stem cells to replicate and transform into different tissues decrease and our body's degenerate and chronic diseases develop.  

Regenerative Medicine is the NEW emerging field of Medicine focusing on reawakening our own body's regenerative and healing abilities....  perhaps in the future leading to discovering the proverbial "Fountain of Youth?"  


3. What are the different Types of Stem Cell?

  There are two basic types of stem cells:

  1. the first type are Embryonic Stem Cells which are PLURIPOTENT or unlimited stem cells and can turn into any kind of cell.    These stem cells come from fetal tissue, embryos which in itself raises ethical issues.  In addition, these cells are NOT FDA regulated and can not be used in the United States. This is the treatment Americans go to foreign countries to receive where there are not strict regulations.   Pluripotent embryonic stem cells can be very dangerous. because  these cells have the capacity to over-replicate and may cause tumor formation.  We NEVER use embryonic stem cells.
  2. The second type are MULTIPOTENT or "limited" stem cells.  These need to be cryogenically frozen or immediately transplanted into the body.  Multipotent stem cells can either be derived from one's own body, mainly from bone marrow or fat and are referred to as "Adult Stem Cells," or they can be obtained from placental tissue such as the placenta, umbilical cord and amniotic fluid, the after birth which is usually discarded, not the fetus.  Multipotent cells know when to shut off and have not been show to form tumors like embryonic stem cells.


4. Why use amniotic or umbilical derived message signaling cell allografts rather than your own fat or bone marrow stem cells?

  
Not all stem cell therapy transplants are equivalent.  As we age the the fewer stem cells we have, especially in the bone marrow, and the ones we do have are not as robust.  Therefore, unless you are in excellent health in your 20's, it is probably beneficial to use placental derived stem cell message signaling cells and growth factors. Although adipose tissue does yield more stem cells than bone marrow, the viability of fat-derived stem cells is very limited and most die within 48 hours.

Also, obtaining stem cells from fat tissue via liposuction or from bone marrow is an invasive procedure. The procedure can be painful and there is a significant rate of complications such as infections especially in older people who have diabetes or chronic diseases.   Twenty-nine percent of patients end up with chronic pain after bone marrow aspirations.    

Amniotic and umbilical derived cells and growth factors are derived from the tissues supporting the growth and health of the fetus and contain a high number of live message signaling cells, high concentrations of growth factors, cytokines, exosomes and other regenerative materials.  Therefore, at REJUVAnation Medical Center,  we use amniotic and umbilical tissue-derived tissue message signaling cells which provide the highest concentration of viable cells for the best results for healing and regeneration.


5. What are the Exosomes?

Most everyone has heard of Stem Cells, but what are EXOSOMES?  Exosomes are the micro-tiny vesicles which are naturally released by stem cells that transport proteins, growth factors, and anti-inflammatory factors to the areas needing repair. Exosomes are the way stem cells signal injured tissue to heal and regenerate. The problem is that as we age, not only do the number of our own stem cells decrease, but in addition there is a decline in the regenerative potential of our cells, especially in Exosomes.


Exosomes are the newest forefront in Regenerative Medicine.   In our practice we use Exosomes derived from young, powerful, placental-derived mesenchymal stem cells which are stored in FDA-registered tissue laboratories. Exosomes are packed with billions of potent growth factors, regenerative proteins and nucleic acids.  


Exosomes may potentially be a promising treatment for neurological disorders affecting the brain such as stroke recovery or alzheimers since they are acellular and small enough to cross the blood-brain barrier?
 

6. What type of conditions benefit from Amniotic, Umbilical, and Placental Allograft Therapy?

Multiple regenerative medicine treatments are being used in many medical specialties. The following are the conditions being treated with amniotic and umbilical allografts and regenerative medicine at REJUNVAnation Medical Center:


  • Arthritis
  • Sport's Injuries
  • Degenerative Arthritis of all types
  • Soft tissue conditions such as tendonitis, bursitis, ligament injuries
  • Knee, Elbow and Shoulder Pain
  • Tennis/Golfer's Elbow
  • Erectile Dysfunction
  • Peyronie's Disease
  • Vaginal Rejuvenation
  • Hair loss: Male pattern hair loss and Hair loss in women
  • Facial Rejuvenation - wrinkles
  • Autoimmune Diseases
  • Chronic Degenerative Diseases
  • COPD
  • Organ Failure - Heart, Kidney
  • Lyme Disease
  • Neuropathy
  • Neurological Conditions


7. Are the procedures safe?

Yes. More than 100,000 injections have been performed without reported adverse side effect. Amniotic and Placental allograft therapy is a preferred type of regenerative therapy because the allograft is is immune-privileged, because it does not express HLA type antigens. HLA type antigens are what can cause patient-rejection.  When using umbilical cord tissue, all red blood cells are removed which removes the HLA factors and prevents any Graft versus Host rejection reaction. 

 
In fact, there is many peer-reviewed studies demonstrating that amniotic/placental allografts and exosomes may even have anti-microbial, anti-inflammatory, and anti-tumorigenic characteristics. The use of amniotic and umbilical derived allografts is well researched, safe, and effective. Amniotic allografts have been used by ophthalmologists and plastic surgeons for about 20 years. All donors go through a rigorous screening process, as determined by the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB).  


8. How are the amniotic and umbilical allografts acquired?

The amniotic and umbilical cord tissues are obtained from healthy, consenting donors who are under the age of 35 and are undergoing a scheduled c-section. The FDA strictly regulates the process of how these tissues are acquired, tested, processed and stored at an FDA registered, certified laboratory to ensure the highest level of patient safety. There are no ethical issues. None of this biologic material ever comes from aborted fetuses, only form the "discarded" products of conception including the amniotic fluid, placenta and umbilical cord from healthy babies born via planned c-section. There is no embryonic or fetal tissue.


9. Benefits of amniotic or umbilical allograft therapy for orthopedic and joint pain?

Amniotic and Umbilical allograft treatment and Exosomes harness the body’s ability to repair itself. These message-signaling cells and repair factors have anti-inflammatory properties, similar to cortisone and steroid shots. They contain no steroids and rely on naturally occurring anti-inflammatory agents such as cytokine, and go far beyond the benefits of standard “injection therapy." While cortisone and other drugs only provide temporary pain relief, stem cells actually REPAIR, REGENERATE, and RENEW degenerated and damaged tissue while providing pain relief.  Additionally, these injections contain hyaluronic acid, which lubricates joints and tendons, easing the pain and helping restore mobility.  

10. What is the difference between PRP and Amniotic and Umbilical Allograft Therapy? 

PRP is platelet rich plasma derived from your own blood and contains about 8-12 growth factors. Amniotic or Umbilical fluid may contain 100's of growth factors along with live message signaling cells, cytokines and other regenerative elements. PRP is helpful in regenerative medicine and complements and enhances other regenerative therapies such as RejuvaWAVE®, but it is not a stem cell therapy.


11. Does insurance cover Regenerative Medicine procedures?

Insurance does not currently cover regenerative medicine procedures for the most part, and the procedures are considered a fee for service


12. Will amniotic or umbilical procedures heal or cure my condition?

Since everyone responds differently to any medical treatment there are no guarantees. Although we have had many patients "cured" of ED or Peyronie's healed or knee-replacement surgeries canceled, no procedure is 100% effective. Most patients will see improvements and relief, but not necessarily 100% cure. The biological elements in these materials and the regenerative procedures work together to repair damaged tissues and also facilitate one's own body to assist in the healing as well. Just how much improvement achieved will vary since each patient is a unique individual and heals at his or her own pace. Amniotic and Umbilical Allograft therapies are the future wave in medicine - to repair and regenerate rather than "band-aid" approach, but any therapies which activate stem cells and regeneration are in its "infancy" and NO promises of cures can be made. Each individual responds uniquely.


13. What is  RejuvaWAVE® ?

RejuvaWAVE®  is a clinically-proven, specific regenerative protocol developed exclusively by  REJUVAnation Medical Center Simply Men’s Health. RejuvaWAVE® uses FDA-cleared technology of low-intensity acoustic pressure waves to enhance blood circulation, stimulate cellular metabolism and tissue regeneration  growing new blood vessels in treated areas. RejuvaWAVE® may CURE Erectile Dysfunction, Peyronie's Disease and REVERSE age-related decline in sexual  performance.

Although acoustic pressure wave therapy for ED is just  being introduced in the United states, acoustic pressure wave therapy  has been used for over 15 years in Europe and Israel, and has been shown to be very effective in  treating Erectile Dysfunction with an over 80% satisfaction rate


14. How does RejuvaWAVE® differ from Gainswave® and other ED Shock Wave Therapies?

REJUVAnation Medical Center Simply Men’s Health is the FIRST to introduce low-intensity shock  wave therapy to Florida in the spring of 2015 and based  on extensive clinical testing developed an exclusive treatment protocol  known as RejuvaWAVE®.  


Acoustic pressure shock wave therapy is now gaining popularity in the  United States as a non-invasive, regenerative treatment and cure for  Erectile Dysfunction and many doctors are introducing the shock wave  technology such as  SwissWave, Gainswave®, DualStim™….  


What makes RejuvaWAVE®.  acoustic  shock wave therapy different is that we use the state-of-the-art Storz  medical device, the treatment protocol and the application technique.  STORZ is a leading manufacturer of medical equipment since 1941 and  developed the only product of it’s kind for safer and most powerful  shock wave therapy and the efficacy has in urology has been proved in  millions of cases.   STORZ is the most advanced and effective pressure  shock wave technology device reporting a 91% success rate according  to clinical studies. 

  

15. What will happen after the Stem Cell procedure?

The procedures are all outpatient and patients are able to go home afterwards, typically within one to two hours. After the procedure the patient should take it easy for the first twenty-four hours. At that point, activity as tolerated may be performed.


16. When can I expect to see results?

Stem cell therapies promote the body to heal and regenerate, so you should not expect to see immediate results.  The first few days immediately after treatment you may feel a bit uncomfortable as the healing process begins and repair cells are drawn to the injured tissues.  Within about 6 -12 weeks you may start to notice improvements, for some much earlier.  Peak healing potential is within 3- 6  months after the therapy, and you may continue to experience further improvement 6- 12 months following your procedure.


With  RejuvaWAVE® alone or with added PRP-Stem cell procedure, some man experience improvements as early as a couple weeks and some take as long as 3 -6 months following the treatment.

Stem Cells are the FUTURE of Medicine and may hold the key to unlocking our body's healing potential

Stem Cells are the FUTURE of Medicine and may hold the key to unlocking our body's healing potential