Patient Guide

An Unbiased Breakdown of All Regenerative Medicine Therapies

REGENERATIVE M E D I C I N E ... Sounds impressive but confusing, right? Well in lay- man's terms it means our bodies were designed to heal themselves! Makes sense... you cut yourself, it heals. Imagine if pain medication was no longer needed. Imagine if the need for a surgical procedure was pro- longed or no longer necessary. Through new technol- ogies in regenerative medicine, there are now treat- ments available that may enhance your own body's natural ability to heal. Regenerative medicine is used for the management of pain, sports injuries, to expedite the healing from surgery, hair loss, sexual health and even to combat the signs of aging. We know that choosing what type of regenerative medicine treatment best suited for you may be con- fusing. For that reason, we have created this unbi- ased booklet to help you make that decision. Our goal is to provide you with the information needed when discussing regenerative medicine options with your physician. It is important to make an educated investment in your health care so you may live your life the way it was meant to be lived.



REGENERATIVE M E D I C I N E From the young model to the aging retiree, from the elite athlete to the weekend warrior, clinicians contin- ue to search for ways to control pain and accelerate the healing process. Regenerative medicine treat- ments have many profound benefits with, in most cases, superior outcomes. Regenerative medicine may treat many conditions that could otherwise require risky treatment ave- nues. There are alternatives to that narcotic you took to get through the pain in your knees. There are other options to conquer your hair loss without undergoing painful surgery. Regenerative medicine treatments harness the power and versatility of the human body to regenerate damaged skin, accelerate healing, reactivate hair follicles, heal wounds and alle- viate pain. The regenerative medicine healing process replaces, creates and regenerates human cells and tissues to maintain normal function, meaning these treatments kickstart the body’s ability to build diminished tissue, improve damaged tissue and restore function that has otherwise deteriorated. When injured or invaded by disease, our bodies have the innate response to heal and defend. Harnessing and enhancing the body's own healing powers with the utilization of regenerative medicine is the new frontier of medi- cine, with results that may be miraculous.

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Treatments being utilized, as a stand-alone or com- bined, include birth tissues from amniotic fluid/mem- brane, umbilical cord tissue, umbilical cord blood, exo- somes, platelet-rich plasma (PRP), adipose-derived stem cells (ADSC) and bone marrow aspirate (BMA). (Figure 2)

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WHAT IS REGENERATIVE MEDICINE? When people think of regenerative medicine, it is often associated with stem cells. Stem cell therapy is taking the regenerative medicine world by storm… but should stem cells get all the credit? It’s a common misconception that stem cells are the only component needed in regenerative medicine to kick- start the healing and regenerative. One of the most valuable aspects of regenerative medicine is that our understanding evolves with science. We once bought into the same “stem cell-based therapy” model that everyone else touts, but as scientists scrutinized the data, we came to embrace a view shared by hundreds of other leading regenerative medicine researchers – including the father of the mesenchymal stem cell, Dr. Arnold Caplan. In June 2017 Dr. Caplan published an article: Mesen- chymal Stem Cells: Time to Change the Name. In this article, Dr. Caplan refers to these cells as “medicinal signaling cells”, capable of influencing function in the body. These factors recruit the patient’s stem cells, which reside throughout all the tissues of our bodies, and affect the responses of our immune system.

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So, if these factors are so effective, why is so much attention paid to stem cells? The answer lies in the fact that the old textbooks remain on the shelves and those who have read them continue to preach their teachings. In addition, alternative regenerative options have only recently become available on the marketplace. However, it is the patient’s own stem cells that do the work, not the stem cells contained in products; these cells serve as a vehicle to deliver messages to our other cells. While we agree that cells are an important part of regenerative medicine, equally important, if not more important, are the “dream team” components of regenerative medicine, com- prised of growth factors and cytokines, that enhance the body’s natural ability to heal and regen- erate. Also, collagens, proteins, hyaluronic acid, and peptides assist in harnessing the body’s power of true healing. Many companies are utilizing procedures that extract the patient’s own stem cells via adipose (belly fat) or bone marrow aspirate (a small plug of bone usually taken from the ilium (hip bone). These procedures are considered invasive, have a higher risk of infection and may cause additional pain to the patient. What many “stem cell” companies fail to mention is that your cells are as old as you are. (Figure 1) As we age, the number of cells and the quality of our cells drastically diminish. With a decrease in cell quality, a person of advanced age will not heal and regenerate like a young child would. New Life Regenerative Medicine products are derived from birth tissues, which means the compo- nents in these products are at day one strength.

HOW DOES REGENERATIVE MEDICINE WORK? Cells are the building blocks of tissue, and tissues are the basic unit of function in the body. Wait… what? To put it simply, cells build tissue and tissue allows our bodies to function and maneuver. Generally, when cells group together, they make and secrete their own support structures. These struc- tures are called the extracellular matrix. This matrix does more than just support the cells; it also acts as a relay station. These cells receive messages from many sources that become available from the local environment. Each message can start a chain of responses that determine what happens to the cell. Through medical technology we can now understand how individual cells respond, interact with their envi- ronment and organize themselves into a healing pro- cess. The extracellular matrix created utilizes various regenerative medicine treatments allowing the tissue to " self-assemble".

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Epimorphosis is defined as the regeneration of a spe- cific part of an organism caused by cell growth, reverse of cells to create structural change, and ref- ormation. Like with a lizard and its tail, epimorphosis restores the anatomy of an organism that existed before the destruction of tissue or structure occurred. This process is similar to utilizing regenera- tive medicine treatments for joint degeneration, hair loss, and more.

WHAT CAN REGENERATIVE MEDICINE BE USED FOR? PAIN MANAGEMENT Pain for most of us comes and goes; some stays and you live with it day in and day out. Imagine a life where pain is constant, taking control of you and, in some ways, the life of those close to you. Imagine having to rely on a narcotic to somewhat lessen the pain just to make it through the day. The Institute of Medicine of The National Academies state that over 116 million Americans suffer from chronic pain, 1.5 billion worldwide. Pain that is caused by trauma, aging, sports injuries, work-related injuries, diseases, the list goes on and on. Drugs are the "first line" of treatment for most forms of pain. To date, the goal of successful pain management is to effectively control patient pain without causing side effects from the medication prescribed. However, only 58% of those who took prescription pain medicine received any form of pain relief and only 41% of those taking over-the-counter pain medication reported relief. The incident of unin- tentional (and preventable) drug overdose-related deaths are growing exponentially. Of all drug-related deaths in the U.S., 43% are due to pain relief medica- tion. 9

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Doctors know that approximately 50% of all patients undergoing pain management will not receive ade- quate relief (Figure 3) at first dosing and/or are at a higher risk of experiencing adverse, potentially life- threatening events. 80% of all pain management drugs are prescribed by the general practitioner or the internist. With the epi- demic of opioid abuse so prevalent, clinicians are looking for other methods to treat pain and injuries through alternative treatments and patients, in turn, are looking for non-invasive options to avoid any type of surgical procedure. With the advancement of med- ical technology, regenerative medicine is now a popu- lar and successful alternative to treat the manage- ment of pain.

SPORTS INJURIES

Sports for professional and recreational purposes are mainstays in American society, but unfortunately so are sports-related injuries. As recent studies increasingly prove the inefficiency and harm of com- monly-used treatments like anti-inflammatory medi- cations and corticosteroid injections, more injured athletes are seeking regenerative medicine thera- pies to heal. Regenerative medicine is now at the forefront of offering such treatments to help athletes overcome injuries without surgery or invasive measures. Sports injuries are most often musculoskeletal condi- tions that occur in the hip, knee, elbow, ankle, shoul- der and foot. (Figure 4) Since tendons, ligaments, cartilage, and bones in that area of the body don't receive a great deal of blood flow, the body can't always heal and regenerate itself effectively. Regen- erative medicine treatments offer a new and effi- cient treatment option that can augment the body's natural healing process and rebuild damaged tissue.

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F I GUR E 4 When treating articular cartilage injuries, for exam- ple, regenerative medicine treatments can both over- come the limited ability of the cartilage to self-repair by providing either new cells or growth factors needed to repair the existing cells. Studies indicate that such techniques can improve the efficacy and consistency of treatment and reduce the potential for future injuries in the same location. Professional and recreational athletes now have a safe and effi- cient alternative to surgery that not only resolves pain but also thoroughly heals difficult injuries.

ANTI-AGING

In addition to baby boomers, now being an average age of sixty-four, the younger generation is feeling the pressures of today's society which has placed a tremendous focus on personal appearance. As recent as ten years ago, the average age for a woman having some type of anti-aging procedure was forty-seven; today that average age is thir- ty-five. Patients, both men and women, are having cosmetic treatments prior to the aging process becoming apparent in their appearance. Regenerative medicine is gaining popularity in the fight against aging. Anti-aging procedures are becoming the fastest growing treatments in cosmet- ics. Treatments being utilized include platelet-rich plasma, also known as the Vampire Face Lift, bone marrow aspirate, amnion liquid, and umbilical cord tissues and blood, all being marketed as "stem cell therapy." (Figure 5)

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"Approaching the age of 60 I noticed the signs of aging were catching up to me, especially in the lip area. Over the past decade, I

have had Botox and facial fillers, but none seemed to last more than a couple of months and I tended to bruise and swell substantially. During a consult with my plastic surgeon, he suggested I try regenerative medicine,

along with a facial filler comprised of hyaluronic acid. To my surprise, I experienced no swelling or bruising post-treatment. I am delighted with the results and, after several months, I see no signs of the effects diminishing." Vicki, C.E.O, Age 61

HAIR RESTORATION

According to the American Hair Loss Association, two- thirds of men will experience hair loss by the age of 35. But women are also affected, making up 40% of all hair loss sufferers. Hair loss around the face affects 90% of all males and females during the aging process and is one of the strongest contribut- ing factors to low self-esteem. In addition, the psy- chological damage caused by hair loss and feeling unattractive can be just as devastating as any seri- ous disease, and in fact, can take an emotional toll that directly affects physical health. The most common cause of hair loss is a hereditary condition called male-pattern baldness or Female-pattern baldness. It usually occurs gradually and in predictable patterns- a receding hairline and bald spots in men and thinning hair in women. Alope- cia Areata is also a major cause of hair loss. During the last ten years or so, there has been great promise for being able to treat hair loss by using regenerative medicine therapies. Regenerative medi- cine may work in numerous ways to improve and regenerate hair by providing nutrition and promoting new blood supply to the follicle; increasing hair shaft size for additional growth. Additionally, studies show growth factors contained within regenerative medi- cine reduce inflammation in the scalp and turn on follicular stem cells to promote hair growth.

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PATIENT TREATED WITH UMBILICAL CORD TISSUE AND PRP

PATIENT TREATED WITH WHARTON’S JELLY AND PRP

WHAT THERAPIES ARE AVAILABLE? BIRTH TISSUES Birth tissue is donated by healthy mothers at the time of normal delivery. Through an informed consent process, expectant mothers submit their past medi- cal and social history which is prescreened through an extensive and complete medical review and pre-natal evaluation. This process is performed before delivery utilizing the protocols established by various regulatory agencies. Additionally, prior to delivery, the mother is tested for communicable dis- eases following the requirements of the Food and Drug Administration (FDA), Center for Disease Con- trol (CDC), and the American Association of Tissue Banks (AATB). (Figure 6) The recovery is performed by specifically trained technicians at the time of the delivery.

TESTING

PURPOSE

HIV I/II Ab

Antibody to HIV Virus Type 1

HBsAG HBcAb

Hepatitis B Surface Antigen

Hepatitis B Core Antibody

HCV Ab

Hepatitis C Antibody

HIV I/II NAT

HIV and HCV Nucleic Assay Testing

RPR

Syphilis Detection Test

WNV

West Nile Virus F I GUR E 6

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Birth tissue has been used for over 100 years for a broad range of therapeutic applications. However, it is only recently that birth tissue was discovered to have great clinical benefit when cryopreserved to protect its residual cells. Since the discovery of birth tissue as a viable regenerative treatment in 2005, there have been no reports of disease transmission. Additionally, birth tissue is considered immune-privi- leged, meaning there is little risk of rejection. Finally, birth tissue products are easy to use as it can be applied directly to the injured site. To date, tens of thousands of patients have been treated with these types of products. Some people may hesitate at the idea of birth tissue. Be assured that the tissue is obtained from healthy, carefully screened mothers at the time of a normal delivery and causes no harm to her or her newborn.

AMNIOTIC FLUID THERAPY

Patients considering invasive stem cell injection treatment to aid in pain management, recovery, or healing may want to consider the rejuvenating quali- ties provided by amniotic fluid. This all-natural regen- erative therapy is a liquid amnion allograft composed of amniotic fluid and features many components that enhance the body's natural healing process. (Figure 7) Just as the amnion (innermost layer of the placenta) protects the fetus during development, it can also provide the same protection to injured or trauma- tized tissue. Amnion contains collagen substrates, a full range of growth factors, amino acids, carbohy- drates, cytokines, hyaluronic acid, fibroblasts, epi- thelial cells, and extracellular matrix. Amniotic fluid has proven to be multipotent and capable of differen- tiating into many different types of cells contained within the body.

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Amnion membrane is rich with the basic components necessary for tissue regeneration. It also contains anti-inflammatory characteristics with the capability to reduce scarring internally and externally. To remove the risk of graft-host reaction*, the chorion* is removed. This will maximize the potential benefits of amniotic membrane in a variety of medical special- ties. Additionally, the immunologically privileged nature of amnion membrane has been shown in a mul- titude of research papers.

*Graft-versus-host reactions occur when the patient’s healthy cells view the newly implanted cells as foreign objects. The patient’s healthy cells then attack and damage the new cells.

*Chorion is the outermost layer of the amniotic sac.

UMBILICAL CORD TISSUE

Also derived from birth tissue within the umbilical cord is the Wharton’s Jelly. Wharton's Jelly is the tissue surrounding the umbilical vein and vessels in the cord. (Figure 8) When the vessels are removed closer to the fetal side of the cord, you have remaining tissue which contains cells termed medicinal signaling cells or MSCs. MSCs are undifferentiated cells (not changed) that can change into any specific cell type in the body. These cells, once deployed to any area of injury or disease, can readily change into the cell type that is needed to repair. Moreover, MSCs are directed to the body's cell signals that recruit them to the site of the injury. Once they reach this area, they dock and begin repairing by releasing cytokines, growth fac- tors and other components that are needed in the healing process. When the vessels are removed closer to the maternal side of the umbilical cord, this tissue contains up to 50 times more growth factors and other compo- nents than the amniotic fluid, but does not contain MSCs. Wharton’s Jelly products are especially bene- ficial for patients over forty that, due to the aging process, have less viable cells than a younger patient would have. (Figure 9)

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UMBILICAL CORD BLOOD

Umbilical cord blood is blood that remains in the pla- centa and the attached umbilical cord after child- birth. Umbilical cord blood contains two types of cells, primarily hematopoietic stem cells* and a small number of medicinal signaling cells*. These cells have the capacity to self-renewal, release growth factors and cytokines, as well as change into more mature cells. As an extension of fetal cells, umbilical cord blood cells exhibit high plasticity. Umbilical cord cells have been used for over twenty years for hematopoietic cell reconstitution as a substitution for bone marrow reconstitution. Additionally, due to the high plasticity of umbilical cord cells, there is a significantly decreased risk of graft-versus-host disease (GVHD) and if GVHD does occur it is less severe than most other types of transplants.

*Hematopoietic Cell: immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. *Medicinal Signaling Cell: plays an important role in many regen- eration processes in the human body.

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EXOSOMES

Older cells are less robust in the production of com- ponents necessary for healing. One option for older patients seeking regenerative medicine treatments is exosomes. Exosomes provide many therapeutic benefits by exhibiting regenerative and immune responses that assist the cells contained within the body to heal and correct. Not all cells in the body are active. Some lie dormant, not working to complete the needs of the body. This population of cells are particularly versatile and once activated penetrate or travel to the sites of injury where they can develop specific characteristics to repair and remodel. Exosomes possess the capability to activate these dormant cells. Exosomes derived from healthy connective tissue cells do not contain DNA. This means that there is no risk of cells developing cancerous characteristics. Additionally, as the cells contained within do not come from the patient’s own body, the number of cells is not limited by the patient’s age.

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"As a long sufferer from degenerative knee pain, I have tried multiple products to maintain my healthy, active lifestyle. My goal every year is to enjoy a skiing season without having to take days off for knee pain and swelling. As a physician, I keep up with medi- cal developments and was excited to hear about the latest regenerative efforts. The science is solid and credible and supports what I have discovered in my own wound healing research. I had an injection of umbilical cord tissue into each knee 4 months before the first ski trip of this year. I was cautiously optimis- tic after six weeks when my knees had less daily dis- comfort and made less 'noise' when I flexed them. I am thrilled to report that I could ski six full days in a row without my usual swelling and pain. I didn't use any anti-inflammatory medications and didn't need to ice my knees one time, even after a day of 30,000 vertical feet. The results exceeded expectation. I am recommending this revolutionary regenerative prod- uct to my friends and to my patients."

Dan, M.D. Plastic Surgeon, Age 60

PLATELET RICH PLASMA (PRP)

Often misrepresented as stem cell therapy, PRP is created by drawing blood from a patient with an anti- coagulant, injecting it in a special tube and placing the tube in a centrifuge. The high speed of the centri- fuge separates the platelets (Figure 10) from the red blood cells. The product is then re-coagulated and sometimes mixed with calcium chloride* to induce the release of growth factors. The PRP is then ready to be used as an autologous tissue* injection or introduced to a surgical site. Platelets are normally known for their responsibility to clot blood, but they also contain proteins known as growth factors that play a vital role in healing injuries. Since the location of most sports injuries does not receive an abundant flow of blood, the injuries are deprived of the platelets and growth factors needed to regenerate damaged tissue. Studies show that PRP treatment can resolve that problem by deliver- ing the injured part of the body with the platelets necessary to support healing. While not as "potent" as other therapies, PRP does contain growth factors and other cytokines that are said to recruit cells to an area of injury to coordinate a repair response. Additionally, PRP activates teno- cytes to proliferate quickly and produce collagen to repair tissue.

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PRP is said to begin working in a few weeks but, alone, can take 6-9 months for its full effect. Howev- er, PRP mixed with New Life Regenerative Medicine products may enhance the healing process and cut the time down by more than eighty percent.

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*Calcium chloride is a calcium salt and an inorganic chloride

*Autologous: Cells or tissues obtained from the same individual

ADIPOSE DERIVED STEM CELLS

Adipose (fat) is collected from the patient via mini-li- posuction. This procedure should be performed by a licensed physician in a hospital setting under light general anesthesia. The physician will determine the most appropriate location(s) to perform the inci- sion(s) for the required fat tissue extraction. One of the most frequently used areas is commonly referred to as the "love handles." The procedure typically takes about an hour. After the procedure, patients are observed for one hour in the post-op recovery room and then an additional one to two hours in another recovery room. Pain medication is prescribed for those who need it although most patients require very little medication. While recovering, your cells will be separated from your fat tissue and the doctor will then inject those cells (just like getting a shot or an IV) back into your body. (Figure 11) The entire procedure normally takes four to five hours and the number of viable cells obtained is greatly dependent on the age of the patient.

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BONE MARROW ASPIRATE STEM CELLS

Bone marrow aspirate concentrate is made from fluid taken from bone marrow. A needle is used to remove bone marrow from within the bone. This is typically done under sedation or general anesthesia. Marrow is commonly taken from the pelvis but may be taken from other sites. The pelvis is marked and prepped to keep the site sterile. A hollow needle is inserted into the bone and a syringe is used to with- draw fluid from the bone marrow. (Figure 12) After enough fluid has been collected, the needle is removed. Pressure is applied to the needle site to stop the bleeding. A small dressing is then applied. After aspiration, there usually is pain at the pelvis that goes away within several days. A small dressing or bandage is kept at the aspiration site until it has healed. The sample of bone marrow is removed and then spun down in a centrifuge to separate the cells. A liquid is produced that has a high concentration of cells. The physician injects the stem cells directly into the surgical site. This method is avoided in patients who have an infection or cancer. Complications may include pain, bleeding, infection and nerve injury. An intra-abdominal injury may occur because of the needle. The success of bone marrow aspirate cells is dependent on the age of the patient

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TESTIMONIALS

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Vinny Testaverde Retired NFL Quaterback Age 54 "Playing in the NFL for twenty-one years as a quar- terback has taken a toll on my body leaving me with chronic pain in my shoulder. Although retired from the NFL, I continue to lead an active lifestyle by work- ing out and playing golf. When the pain in my shoulder became too much to enjoy these activities, I went to my good friend, Dr. Mic McClimans who suggested I try regenerative medicine therapy, including birth tissue stem cells, provided by New Life Regenerative Medicine. It has now been two months since my treatment and the improvement is substantial; I am sleeping better; my golf game has improved, and the pain has substantially subsided. Overall, I would say that the New Life Regenerative Medicine products administered by Dr. McClimans have improved my quality of life." "I am pleased to be one of the recipients of Regener- ative Medicine through a knee injection. My knee was injured 45 years ago (patella dislocation resulting in traumatic shearing of menis- cus cartilage). Prior to injection, I couldn't play golf without a cart. Playing multiple days in a row routine- ly resulted in minor swelling. I had the injection in late August. At the end of September, I spent a week in the Hamptons and played multiple rounds of golf. More impressively, I could play tennis and some bas- ketball. Although my athletic prowess was far short of noteworthy, my knee was exceptional; I had no swelling. Clearly, this has been a very positive result for me."

Jim Businessman Age 73

“ Truly, the most important investment we can make , with the greatest return,

is in the health and duration of our lives, so that we may fully enjoy our family, iends and uits of our labor.”

New Life Regenerative Medicine ®

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