Before the Holidays Hit: How Men Over 40 Can Reset Hormones, Sleep, and Energy This Fall

Optimize Your Autumn: A Man's Guide to Reversing Low T, Battling Stress, and Reclaiming Vitality After 40

 As summer fades and cooler air rolls in, autumn offers the perfect opportunity for men over 40 to reset their health routines. Halloween and Thanksgiving have just passed us by and Christmas and New Years is just around the corner. Most of us will be indulging in holiday parties and for the next few months, health isn’t going to be on the forefront of our list of priorities. This season isn’t just about cleaning out your garage or setting new goals—it’s about recharging your body’s foundation. Having a routine founded in disciple and sound medical experience can help keep us looking and feeling our best during one of the tougher times of the year to stay motivated.

At NovaGenix Health and Wellness, we help men navigate this pivotal time of year and stage of life by focusing on three essential pillars of vitality: hormonal balance, restorative sleep, and effective stress management. When these systems are working together in harmony, men experience more energy, sharper focus, improved strength, and a greater sense of well-being. Optimizing health and both physical and mental wellness will play huge roles in maintaining physique and hormonal balance through the winter months which keeps men happy and healthy.

Studies have shown that if left unaddressed, declining testosterone, poor sleep, and chronic stress can lead to weight gain, fatigue, mood changes, and reduced performance—both physically and mentally. With the weather getting colder and the seasons changing, here’s how to reset and restore your body this fall and winter.

 

Test and Optimize Your Hormones: Support Testosterone and Metabolism 

For most men, testosterone levels begin to gradually decline by age 30 at a rate of 1 to 2% annually. By the time you hit your 40s and beyond, that dip can become noticeable—impacting muscle mass, energy, libido, and overall vitality. It’s a slow decline but one day you’ll wake up and wonder… “what happened to me?” A friend of mine recently noticed that his body has started to fall apart after having turned 50. This is common and testosterone deficiency plays a major part in this noticeable decline in performance, physique, mood and libido, to name a few.

Seasonal changes can also influence hormone health. We just recently went through daylight savings and reset the clocks back an hour. As total daylight shortens, Vitamin D levels drop—affecting testosterone production and mood regulation. This seasonal depression is a very real thing and can wreak havoc on our emotional and hormonal wellbeing causing a disruption in serotonin and testosterone production.

 

Fall Hormone Optimization Strategy for Men

Prioritize Resistance Training
Strength training is the best natural way to boost testosterone levels. Focus on compound movements that target whole body and large muscle groups such as squats, deadlifts, and bench presses three to four times per week. Total body exercises help increase muscle mass, burn fat and boost natural testosterone production.

Maintain a Healthy Body Composition
Excess body fat produces an enzyme called aromatase which converts testosterone into estrogen. Keeping body fat in check will help to support optimal hormone balance. More fat means more estrogen and less testosterone. More muscle means more testosterone and less fat. It’s a controllable cycle that can help keep us within the upper range of normal levels. Keep in mind that all men have different hormone levels and this is due to a number of factors such as age, diet, lifestyle factors and genetics which is why speaking with an experienced physician is important.

Support Key Nutrients
Ensure adequate Zinc and Magnesium intake to support testosterone synthesis as these 2 nutrients are important in hormone production. Oysters (the absolute best source), Red Meat (especially beef and lamb), Pumpkin Seeds, and Legumes (like lentils and chickpeas) all contain zinc. Dark Leafy Greens (spinach and kale), Almonds and Cashews, Avocados, and Dark Chocolate (70% cocoa or higher) all contain magnesium. Incorporating a handful of nuts daily or swapping out refined grains for whole grains (which are also high in magnesium) can also be helpful.

With the days getting shorter and sunlight fades, supplementing Vitamin D3 can help maintain energy and hormone levels through the colder/darker months when we spend less time outdoors and in the sun.

Consider Medical TRT (Testosterone Replacement Therapy)
If symptoms of low testosterone—such as fatigue, low libido, or weight gain—persist, TRT may be the most effective solution. At NovaGenix, we specialize in individualized testosterone therapy for men, restoring levels safely and effectively under medical supervision. Therapeutic doses of testosterone can be a gamechanger for many men whose levels are causing them to show the signs and symptoms of Low T.  Prescription testosterone or even hCG therapy can be quite beneficial for men who have the symptoms of low T and have a blood test to confirm hypogonadism.

 

Sleep: The Cornerstone of Recovery and Hormone Health

Sleep is not a luxury—it’s a biological necessity. During deep sleep and REM, your body releases critical hormones like Human Growth Hormone (HGH) and testosterone, both essential for recovery, muscle repair, and fat metabolism.  Poor sleep quality, which becomes more common in midlife, can elevate cortisol (the stress hormone) and lower testosterone production. Having kids and jobs can often lead to sleepless nights and higher levels of stress. Research has shown that an extra hour of sleep can drastically improve serotonin levels, testosterone production and overall health and wellness. Sleep is vital for hormone production.

Sleep Optimization Strategy

• Stick to a consistent bedtime Routine
  Go to bed and wake up at the same time every day, even on weekends. Consistency reinforces your body’s circadian rhythm.
• Cool the Room
  A slightly cooler environment (60–67°F) promotes deeper, more restorative sleep according to studies.
• Unplug Before Bed
  Turn off screens at least an hour before bedtime. Research has shown that blue light suppresses melatonin, the hormone that signals it’s time to sleep.
• Check Your Hormones
  If sleep issues persist, low testosterone or imbalanced cortisol could be the culprit. A simple hormone panel at NovaGenix can help identify and correct these underlying issues.

 

Manage Stress: Lower Cortisol and Protect Vitality

Chronic stress is one of the most overlooked causes of hormonal imbalance. Elevated cortisol levels over time can lead to belly fat accumulation, blood sugar instability, and a weakened immune system, all of which accelerate the effects of aging. It’s harder said than done, but avoiding stress and finding coping mechanisms like a hobby or meditation for example, can help tremendously.  A good stress management strategy will Schedule Downtime and set aside at least 15 minutes daily for deep breathing, meditation, or quiet  reflection. Consistency is more powerful than duration and people who engage in activities like yoga, for example, report less stress as a result when done on a regular basis. Gentle movements such as walking, tai-chi, yoga, or stretching—reduces stress hormones and enhances mood without overtaxing your system.

 

Fuel Your Fall: Nutrition for Hormone and Immune Health

 

What you eat directly affects your hormone function and resilience. By prioritizing a healthy diet full of whole, nutrient-dense foods you can stabilize blood sugar and support gut health as well as provide your body with the building blocks that produce hormones. A few key tips to think about is to include Omega-3 fatty acids (salmon, walnuts, flaxseed) for anti-inflammatory benefits. Also be sure to eat plenty of fiber to support digestion and hormone metabolism and always try to stay well hydrated and limit processed sugars and alcohol, which can disrupt testosterone balance and sleep quality.

Reclaim Your Energy This Fall with NovaGenix

This fall, take the time to reset your health from the inside out and make your health a priority. By optimizing your hormones, improving your sleep, and mastering stress management, you can turn seasonal slowdown into a season of strength and renewal and improve the way you look and feel.

At NovaGenix Health and Wellness, we specialize in helping men restore balance, energy, and confidence through personalized testosterone replacement therapy (TRT) and hormone optimization programs for the past decade in South Florida .

Schedule your free consultation today with Dr. Mackey to learn how NovaGenix can help you take control of your health and feel your best all year long. Call us at 561-277-8260 to learn more

Stem Cell Therapy in Florida: The Science, Safety, and Solutions at NovaGenix

Florida's New Stem Cell Law: What Patients Need to Know about Therapies at NovaGenix

Stem Cell Therapy and Regenerative Medicine in Jupiter, Florida

 

At NovaGenix we have been treating patients with innovative regenerative Stem Cell treatments that are designed to stimulate the body’s ability to repair and regenerate naturally without the need for invasive procedures and surgery. NovaGenix is dedicated to providing cutting-edge wellness solutions, and our commitment extends to the exciting field of regenerative medicine. We are proud to offer advanced stem cell therapy at our Jupiter, Florida location, allowing patients to tap into their body's innate ability to heal and regenerate. With the recent passage of Florida Senate Bill 1768, which went into effect in July of 2025, we can now provide these innovative, minimally invasive treatments for a variety of conditions, including orthopedics, wound care, and pain management. Our therapies utilize carefully processed cells from sources like a patient's own blood or umbilical cord tissue, all while adhering to the new law's strict safety and ethical standards. If you're looking for a natural approach to healing and wellness, contact us today to learn more about stem cell therapy.

Senate Bill 1768 Regarding Stem Cell Therapy in Florida

Recently Florida passed into law new legislation which permits doctors the ability to treat patients with Stem Cells. Florida's new stem cell bill, designated as Senate Bill 1768, authorizes licensed physicians to provide stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for specific conditions, including orthopedics, wound care, and pain management. The law, which went into effect on July 1, 2025, aims to expand patient access to these treatments while establishing a regulatory framework to ensure patient safety and ethical standards.

Key provisions of the bill include:

• Source and Manufacturing Requirements: Stem cells used must be sourced from facilities that are registered with the FDA and certified or accredited by recognized organizations like the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks. The law specifically prohibits the use of cells derived from a fetus or embryo after an abortion.
• Informed Consent and Transparency: Physicians are required to obtain a signed informed consent form from patients, which must explicitly state that the therapy is not FDA-approved. Advertisements for these therapies must also include a clear disclosure about their unapproved status. (See the informed consent form here)
• Penalties for Violations: The bill establishes criminal penalties, including felony charges, for violations such as using human cells or tissues derived from a fetus or embryo after an abortion, or the unauthorized sale, manufacture, or distribution of computer products created using human cells.

 

Patients can receive Stem Cell treatments that are minimally invasive. These manipulated tissue allografts are derived from a patient’s own blood or umbilical cord tissue layers from Wharton’s Jelly and are then processed in a cell bank to maximize cellular concentrations for use and research. These allograft tissue products are intended to be used to enhance the body’s natural healing ability. Stem Cell therapy and regenerative medicine is a cutting-edge area of medicine that has the potential to completely repair and heal damaged tissues, cells, and organs. There are many interesting clinical trials and research articles about these cells.

 

Natural biologic stem cell products involve the manipulation of human cells, tissues, or organs to restore normal function through tissue engineering and molecular biology. The human body will naturally respond to injury or disease by initiating processes of healing and defending themselves on a cellular level.

The current frontier in modern medicine is showing an increasing interest in the exploration, utilization, and enhancement of the body's innate healing abilities, creating seemingly miraculous outcomes for those who undergo these procedures without having to undergo surgery. However, these "miracles" are the tangible results of ongoing scientific exploration, tapping into the extraordinary ability of the body’s own cells to heal and regenerate and is constantly evolving field in medical science.

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What Are Stem Cells?

Stem cells are unique, unspecialized cells with the ability to develop into various other cell types and to self-renew. This dual function allows them to repair and regenerate tissues. There are different types, including embryonic, adult (somatic), and induced pluripotent stem cells.

In the U.S., the only FDA-approved stem cell treatments are hematopoietic (blood) stem cell transplants for blood and immune system disorders. Other stem cell therapies are considered experimental and are not approved by the FDA. The FDA regulates all stem cell products, and you can find information on clinical trials at ClinicalTrials.gov.

The FDA warns against unapproved products for a wide range of conditions, including orthopedic, neurological, cardiovascular, and pulmonary diseases, as well as COVID-19, chronic pain, and more.

Stem Cell Therapy & Sources

Stem cell therapy uses stem cells to treat or prevent diseases by replacing damaged cells. This field is promising for its potential to treat many conditions, from degenerative diseases to injuries.

Stem cells can be sourced from various places:

·         Embryonic stem cells come from embryos and can become any cell type, but their use is ethically debated and these types of stem cells are not legal in Florida.

·         Adult stem cells are found in tissues like bone marrow and fat. They are more specialized and are key for tissue repair throughout a persons life.

·         Induced pluripotent stem cells (iPSCs) are created in a lab by reprogramming adult cells, offering a way to get pluripotent cells without using embryos.

·         Umbilical cord stem cells are collected from cord blood after childbirth and are rich in hematopoietic stem cells, which are used in the only FDA-approved treatments. Donors go through a rigorous vetting process, and cells are tested and certified.

·         Wharton's Jelly is a substance in the umbilical cord that contains valuable mesenchymal stem cells.

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Common Applications of Stem Cells

While still largely experimental, stem cell therapy is being explored for conditions such as:

·         Blood Disorders (e.g., leukemia)

·         Orthopedic Issues (bones, joints, cartilage)

·         Autoimmune Diseases

·         Cosmetic and Anti-Aging Procedures

·         Chronic Pain

·         Wound Care

It's crucial to consult with licensed and experienced healthcare professionals and ensure that any therapy complies with current regulatory standards and best practices.

Here are a few examples of research papers dedicated to the understanding of these incredible cells:

• Stem cell-based therapy for human diseases
•  An introduction to stem cells
•  Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice
•  Human Induced Pluripotent Stem Cells: From Cell Origin, Genomic Stability, and Epigenetic Memory to Translational Medicine

A Prescription Cream for Localized Fat Reduction: The Science Behind Aminophylline/Glycyrrhetinic Acid Cream

Unlock Targeted Fat Loss with Aminophylline/Glycyrrhetinic Acid Cream

Are you frustrated by stubborn fat that just won't go away, no matter how much you diet and exercise? You're not alone. Many people struggle with localized fat deposits in areas like the abdomen, thighs, and hips, which seem resistant to traditional weight loss methods. At NovaGenix, we understand this struggle, which is why we're proud to offer a cutting-edge, physician-compounded solution: Aminophylline/Glycyrrhetinic Acid Fat Loss Cream. This isn't just another fad product; it's a scientifically backed, prescription-strength cream designed to target fat cells directly.

The Science Behind Targeted Fat Reduction

To understand how this cream works, you need to know about fat cells, or adipocytes. The process of fat accumulation and breakdown is complex, regulated by hormones and enzymes. The goal is to stimulate lipolysis, the process of breaking down stored fats into fatty acids that your body can use for energy.

• Aminophylline: The Lipolysis Accelerator Aminophylline is a powerful ingredient that works by inhibiting an enzyme called phosphodiesterase (PDE). By blocking PDE, Aminophylline increases the levels of cyclic adenosine monophosphate (cAMP) within fat cells. Higher cAMP levels act as a signal to your fat cells, telling them to release their energy stores. This topical application allows the active ingredient to be delivered directly to the problem area, maximizing its effect exactly where you need it.

• Glycyrrhetinic Acid: The Fat Formation Inhibitor Derived from licorice root, Glycyrrhetinic Acid complements the action of Aminophylline. It works by inhibiting an enzyme called 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1), which is responsible for converting inactive cortisone into active cortisol in your fat cells. High cortisol levels are linked to increased fat storage, especially in the abdominal area. By blocking this enzyme, Glycyrrhetinic Acid reduces local cortisol production, which discourages the formation of new fat cells. The combination of Aminophylline and Glycyrrhetinic Acid provides a two-pronged attack on stubborn fat: one component breaks down fat, and the other helps prevent new fat from forming.

What the Studies Show

The effectiveness of these compounds isn't just theoretical; it's supported by clinical evidence. A systematic review of clinical trials on topical aminophylline found that the majority of studies reported a significant reduction in fat on treated areas compared to control groups. One study even reported an average reduction of 11 cm in waist circumference.

Another notable study focused on Glycyrrhetinic Acid cream, which showed a significant reduction in both the circumference and thickness of the superficial fat layer on the treated thigh of healthy women with a normal BMI. These studies provide compelling evidence that this compounded cream can deliver real, measurable results for targeted fat loss.

At NovaGenix, we believe in a holistic approach to health. This cream is a powerful tool to be used in conjunction with a healthy diet and regular exercise, not as a standalone solution. It's especially beneficial for patients on specific treatment plans.

• For Patients on GLP-1 Medications: GLP-1 agonists like Semaglutide and Tirzepatide are highly effective for overall weight loss. However, they don't always target stubborn subcutaneous fat in areas like the love handles or lower abdomen. Our fat loss cream can be applied to these specific areas to enhance fat loss efforts and achieve a more contoured, aesthetically pleasing result.

• For Patients on TRT/HRT: Hormone Replacement Therapy (HRT) and Testosterone Replacement Therapy (TRT) improve overall body composition by increasing lean muscle mass and reducing fat. However, they may not eliminate every last bit of stubborn fat. For men with residual abdominal fat or "love handles" and women with fat deposits around the hips and thighs, this cream provides a targeted solution that works synergistically with their hormone therapy.

How This Cream Enhances Your Wellness Journey

The journey to a healthier, more confident you is a personal one. Aminophylline/Glycyrrhetinic Acid Fat Loss Cream represents a significant step forward in targeted fat reduction. By combining two clinically-backed ingredients, this cream offers a non-invasive, localized solution to stubborn fat that can be seamlessly integrated into your existing health and wellness regimen.

Whether you're on a GLP-1 weight loss journey, optimizing your body with TRT/HRT, or simply looking to tackle those last few problem areas, this innovative cream can help you achieve a new level of body confidence.

Whether you're on a GLP-1 weight loss journey, optimizing your body with TRT/HRT, or simply looking to tackle those last few problem areas, this innovative cream can help you unlock a new level of body confidence. Contact NovaGenix today to schedule a consultation and find out if this is the right solution for you.

Statistics and Data on Obesity

Based on recent data from sources like the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC):

1. Global Prevalence: In 2022, more than one billion people worldwide were living with obesity, and approximately 43% of adults were overweight.
2. U.S. Adult Obesity Rate: More than two in five adults (42.4%) in the United States have obesity.
3. Childhood Obesity: The prevalence of obesity among children and adolescents has quadrupled globally since 1990. In the U.S., about one in five children and adolescents (19.7%) have obesity.
4. Racial and Ethnic Disparities (U.S.): Obesity affects some groups more than others. Non-Hispanic Black adults (49.6%) and Hispanic adults (44.8%) have higher obesity rates than non-Hispanic White adults (42.2%) and non-Hispanic Asian adults (17.4%).
5. Economic Impact: Obesity is a costly public health issue. In the United States, the annual medical costs related to obesity were nearly $173 billion in 2019. Medical costs for an individual with obesity are an average of $1,861 higher per year than for a person of a healthy weight.

 

References (Trials and Studies)

Systematic review of topical aminophylline: The article cites a systematic review that analyzed data from various clinical trials on the local fat-burning potency of topical aminophylline. This review concluded that most studies showed a significant reduction in fat on treated areas compared to control groups. It also mentioned that topical aminophylline is a safe and effective, non-invasive alternative for localized fat reduction, with one study reporting an average of an 11cm reduction in waist circumference.

Study on Glycyrrhetinic Acid and subcutaneous thigh fat: The article references a study that investigated the effects of a Glycyrrhetinic Acid cream on subcutaneous thigh fat in healthy women with a normal BMI. The results showed a significant reduction in both the circumference and thickness of the superficial fat layer on the treated thigh compared to the untreated leg and a placebo group.

Research on the mechanism of action: The article explains the underlying science by referencing the roles of Aminophylline and Glycyrrhetinic Acid. It describes Aminophylline as a phosphodiesterase inhibitor that increases cAMP levels to stimulate lipolysis (fat breakdown). It also describes Glycyrrhetinic Acid as an inhibitor of the enzyme 11β-hydroxysteroid dehydrogenase type 1, which reduces the local production of cortisol in fat tissue, thus discouraging new fat cell formation (adipogenesis).

Low-T symptoms most men ignore in their 40s

The Sneaky Signs of Low-T: What Men in Their 40s Need to Know

 

It’s inevitable for most guys that as time moves on, we start to feel the effects of aging. Men in their 40s often navigate a whirlwind of career demands, family responsibilities, and social engagements that start to take their toll. In this stressful and busy stage of life, subtle shifts in a guy’s health and well-being can easily be dismissed as simply "getting older" or the result of stress. However, some of these seemingly minor changes could be indicative of a significant underlying issue: low testosterone, often referred to as "Low-T." Recognizing the symptoms of Low-T is crucial, as ignoring them can negatively impact various aspects of a man's health and quality of life. At NovaGenix, a leading health and wellness center in Jupiter, Florida, we believe in empowering men to take proactive steps towards their health. This article will shed light on some of the most commonly overlooked Low-T symptoms in men during their 40s.

One of earliest signs of a hormone imbalance that starts to effect men and is often most disregarded, is persistent fatigue. While everyone experiences tiredness after a long day, the fatigue associated with Low-T is often more profound and doesn't improve with adequate rest. Men might find themselves feeling drained even after a full night's sleep, experiencing a lack of energy that interferes with their daily activities. You get home from work and just sink into the couch or lay down to rest your eyes for just a minute and pass out. You kids want to play but you need a cup of coffee first before you can be dad and take them out to play with them. This isn't just regular tiredness; it's a pervasive lack of vitality that can impact motivation and productivity. It’s more common than you think.

Another subtle symptom many men attribute to stress or aging is decreased libido and erectile dysfunction. Changes in sexual desire and performance can be emotionally challenging, leading many to avoid discussing them. It often leads to martial issues. It's not just about physical connection, but also about the emotional closeness, trust, and vulnerability that couples share. When intimacy wanes, a marriage can begin to suffer in a number of significant ways, leading to feelings of loneliness, resentment, and a breakdown in communication. It’s difficult for a husband to explain to his wife why these issues exist as it’s often either embarrassing or they don’t understand the reason behind their decreased sex drive. Testosterone plays a vital role in sexual function, and a decline in its levels can directly contribute to reduced interest in sex and difficulties achieving or maintaining an erection. Ignoring these changes can not only affect intimacy but also signal a broader hormonal imbalance.

Changes in mood and cognitive function are also frequently overlooked. People just brush it off as stress from work of life. Men with Low-T may experience increased irritability, anxiety, and even symptoms of depression. They might also notice difficulties with concentration, memory, and overall mental sharpness. These changes can be mistakenly attributed to work stress or other life pressures, delaying the recognition of a potential hormonal cause. It turns out that when testosterone levels are optimized, men tend to feel better, are more energized and hence FEEL better as well. This tends to have a positive effect on multiple aspects of a mans life.

Physical changes, though sometimes more noticeable, can still be dismissed as part of the natural aging process. Reduced muscle mass and increased body fat, particularly around the abdomen, can be linked to lower testosterone levels. We all remember seeing pictures of our dads when they were young and fit, and then as time goes on, many of these guys start to put on a little belly fat and we just assume that’s a normal part of life. But it doesn’t have to be. Men might find it harder to build or maintain muscle even with consistent exercise, and stubborn belly fat may become more prevalent but testosterone can help fix that problem. Similarly, a decrease in bone density, although often asymptomatic initially, can increase the risk of fractures over time and is another potential consequence of Low-T. It’s quite common to hear stories about older men who fell and broke a hip. As men get older and testosterone levels drop, so does bone density.

Finally, seemingly minor symptoms like sleep disturbances and decreased body hair can also be indicative of lower testosterone levels. Changes in sleep patterns, such as insomnia or difficulty staying asleep, can be linked to hormonal fluctuations. A gradual thinning of facial or body hair might also be a subtle sign that testosterone levels are declining.

It's important to remember that these symptoms can have various underlying causes so it’s important to seek the advice from you physician to determine what may be the actual cause of any symptoms you may be experiencing. However, if you're a man in your 40s experiencing several of these seemingly unrelated changes, it's worth considering the possibility of Low-T. Ignoring these symptoms could delay necessary treatment and allow the negative effects of low testosterone to persist and potentially worsen.

At NovaGenix in Jupiter, Florida, we offer comprehensive testing and personalized treatment plans to help men address Low-T and reclaim their vitality. Our experienced medical professionals and physician Dr. Timothy Mackey understand the nuances of hormonal health and can provide accurate diagnosis and effective management strategies. If you're experiencing any of the symptoms mentioned above, we encourage you to schedule a consultation. Taking proactive steps towards your health in your 40s can significantly impact your well-being and quality of life for years to come. Don't dismiss these subtle signs – your health is worth prioritizing.

Stem Cell Consent Form

Consent Form 

I hereby volunteer to serve as a patient to demonstrate specific procedures associated with a field of medicine known as "regenerative medicine." 

I specifically request and authorize _________________________ to arrange for the provision of regenerative medicine products and procedures to me in an educational setting to instruct licensed healthcare professionals on the proper administration (e.g., injection) of regenerative medicine products and procedures; I further understand and agree that the Food and Drug Administration generally characterizes such regenerative medicine products and procedures as experimental, and I understand and agree that none of these regenerative medicine products or procedures are reimbursable by any health insurance. As such, I agree not to submit claims to any such insurer for or in connection with the regenerative medicine products or procedures I desire to receive. 

By signing below, I agree to receive the following experimental products and procedures: 

WHARTON'S JELLY ALLOGRAFT (includes Growth hormones, growth factors, and stem cells). 

ALLOGENIC UMBILICAL CORD BLOOD ALLOGRAFT DEPLOYMENT (includes growth factors, growth hormones, and stem cells). 

AUTOLOGOUS BONE MARROW ASPIRATE DEPLOYMENT (includes growth hormones, growth factors, and stem cells). 

ALLOGENIC AMNIOTIC TISSUE ALLOGRAFT DEPLOYMENT (includes growth factors, growth hormones, and stem cells). 

 EXOSOME DEPLOYMENT _____

PRP (Platelet Rich Plasma) or PRF (Platelet Rich Fibrin)

 I understand that many people may benefit from autologous and/or allogeneic cell therapy for various medical problems. Recent medical studies have shown that cell therapy can help some subjects. Regenerative Biological solutions from Wharton's Jelly tissue, bone marrow, umbilical cord blood, and amniotic fluid contain adult mesenchymal stem cells. My receipt of such products and services entails deploying Regenerative Biological solutions to candidates who meet the other medical screening criteria that have been generally established

I have been given plenty of opportunities to ask questions about this information. Before signing, I have been further offered to take this form home for consideration (including to my legal counsel). I take full responsibility for disclosing my complete and accurate medical history and complying with all pertinent treatment and monitoring programs. I understand that by failing to disclose my medical history and conditions thoroughly, obtain recommended testing, and adhere strictly to the protocol, I could be exposed to severe medical risks, including cancer, disability, and death. I am not a candidate for Regenerative Biological solutions deployment if I have actively growing cancer; I take full responsibility for making such disclosures to the treating office before receiving any products or services. I understand and agree that my receipt of regenerative medicine products and services will be observed for educational purposes. I further understand and agree that the provider may use images of my treatment for commercial purposes, and I hereby consent to such. 

OSSIBLE BENEFITS 

The potential benefits of Regenerative Biological solutions deployment for eligible patients may include improving certain chronic degenerative diseases. Although some benefits often occur, some patients will experience all of them, some will experience some of them, and some patients will be non-responders and not experience any of them. Also, the degree of benefit varies. The long-term effects of Regenerative Biological solutions deployments are unknown. 

POSSIBLE RISKS OR DISCOMFORT 

he potential risks of Regenerative Biological solutions deployment include, but are not limited to complications of bone aspirations (bleeding, bruising, discomfort, infection, scar, unwelcome cosmetic effects, reaction to local anesthesia, damage to internal organs), local reactions to intravenous infusion of Regenerative Biological solutions (you may experience pain, bruising, vein thrombosis, swelling, hematoma, or bleeding at the puncture site), side effects of intraarterial injection of Regenerative Biological solutions, (such as embolization, "clots", damage to arteries and organs, immediate or delayed uncontrolled bleeding from the puncture site are all conceivable possibilities), allergic reaction to DMSO preservatives up to and including death, side effects of intra-venous injections of Regenerative Biological solutions (such as joint pain, swelling, bleeding, infection), side effects of Regenerative Biological solutions injection into the spine, Host vs. Graft disease, embolism from extraction site, including epidural space and cerebrospinal fluid space, and side effects of Regenerative Biological solutions injection into soft tissue (such as swelling, pain, bleeding, or damage to nerves or internal organs). There are also unknown long-term effects of autologous and/or allogenic Regenerative Biological solutions therapy. Other possible risks could include potentially harmful reactions to resuscitative medications or measures (chest compressions, electrical shock, CPR in general, and/or call 911) if a life threatening reaction is encountered and requires treatment. If you experience an adverse reaction after you return home, please contact the office where you were treated and discuss it with the doctor. The doctor may consult other professionals to discuss your reaction.

If you have an active tumor or cancerous tumor that is present, but you are unaware of its existence, we do not know how it would be affected - it could conceivably be made more aggressive. I agree to be wholly and entirely responsible for disclosing any information concerning my active or cancerous tumor to my provider (before treatment). 

AVAILABLE TREATMENT ALTERNATIVES 

Many diseases being treated by Regenerative Biological solutions deployment may be relieved by other means, and my medical provider can discuss these with me. Some symptoms may resolve naturally without medical intervention. Even if I am a Regenerative Biological solutions deployment candidate, I may experience no improvement and, therefore, would not be harmed by not receiving the deployment. I have been fully informed about the effects and nature of autologous or allogenic Regenerative Biological solutions deployment, the risks involved, the possible complications, and the possible consequences and alternatives. I have been given information about the proposed procedure. I have been allowed to ask questions concerning the procedure type and fully understand the responses. It is my responsibility to read these and abide by the recommendations.

RIGHT TO TRY AND COMPASSIONATE USE DISCLOSURE 

I acknowledge that I have been informed that the regenerative medicine products and procedures I have elected to receive may not be approved by the U.S. Food and Drug Administration (“FDA”) and may fall under investigational or experimental classifications. Some of the products or services may qualify for access under the federal Right to Try Act of 2017 (Pub. L. No. 115–176) or the Florida Right to Try Act (Section 499.0295, Florida Statutes), as well as the Compassionate Use pathway authorized by the FDA for patients with life-threatening or serious conditions who have exhausted approved treatment options. By signing this consent form: - I acknowledge that I have been informed of my right to request access to eligible investigational treatments under the federal Right to Try Act or the FDA’s Expanded Access (Compassionate Use) Program. - I understand that the regenerative medicine procedures being provided to me are not FDA approved for the specific indications for which they are being used, and that safety and efficacy data may be limited. - I voluntarily consent to receive these treatments, recognizing that their long-term effects, risks, and benefits may be unknown or unpredictable. - I confirm that I have had the opportunity to ask questions about these investigational therapies and have received sufficient information to make an informed decision. 

FLORIDA STEM CELL THERAPY DISCLOSURE – HB 1617 (2025) NOTICE TO PATIENT THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy. 

PATIENT ACKNOWLEDGMENT AND CONSENT I acknowledge that: 1. The stem cell therapy I am electing to receive is not approved by the United States Food and Drug Administration (FDA). 2. The therapy is intended for treatment related to orthopedics, wound care, or pain management, which are within the scope of practice for the health care provider. 3. The stem cells used in this therapy: a. Are manufactured in a clean room space certified by the FDA for using high-efficiency particulate air (HEPA) filtration or ultra-low penetration air (ULPA) filtration to minimize contamination. b. Are retrieved, manufactured, and stored in a facility that is registered and regulated by the FDA and licensed or registered with one of the following entities: - National Marrow Donor Program - World Marrow Donor Association - Association for the Advancement of Blood and Biotherapies - American Association of Tissue Banks 4. The therapy does not involve the use of stem cells derived from aborted fetuses or adiposederived mesenchymal stem cells for transplantation. 5. The health care provider will adhere to applicable current good manufacturing practices as outlined in 21 C.F.R. part 1271 during the performance of the therapy. 6. I have received and read the above NOTICE TO PATIENT. 7. I have been informed of the nature and character of the proposed treatment, its FDA approval status, anticipated results, recognized possible alternative forms of treatment, and the recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment. 8. I have had the opportunity to ask questions and have received satisfactory answers. 9. I voluntarily consent to receive the stem cell therapy as described. 

FINANCIAL CONSIDERATIONS I have been informed that my Regenerative Medicine deployment is not covered by health insurance, and therefore, I am responsible for the cost of the product(s) and procedure(s). I authorize the Medical providers to employ assistants, nurses, physicians, radiologists, anesthesiologists, and/or technologists necessary for the procedure and approve their participation. I also authorize the treating physician to perform any other procedures he or she may deem necessary or desirable to improve the conditions encountered during the procedure. You must be advised that we will provide resuscitative procedures in case of an emergency. I For women: Regenerative Biological solutions deployment represents potential unknown risks to pregnant women or those who may become pregnant after deployment. There are also unknown risks to an embryo or fetus. Anesthesia that accompanies this procedure may be harmful to an unborn baby. If you have had a hysterectomy or are post-menopausal, you are excluded from having to take a pregnancy test. Medical providers will provide you with a pregnancy test before the procedure. All that is required is a small amount of urine. The medical provider has advised me to undergo a pregnancy test before my treatment. I am declining to submit to such a test and am certain I am not pregnant. Therefore, I waive any claim against any medical provider should I unexpectedly find myself to be/have been pregnant during my procedure. I also understand that I have the right to request a pregnancy test after signing this Informed Consent. I know the practice of medicine and surgery is not an exact science; therefore, reputable practitioners cannot correctly guarantee outcomes. I acknowledge that no guarantee or assurance (expressed or implied) has been made by anyone regarding the Experimental Regenerative Biological solutions deployment procedure that I have herein requested and authorized. Once treatment has started, no refunds will be given. By signing this Consent, I acknowledge that I (1) read this form (or it was read to me) carefully, (2) asked any question that I wished, and (3) received satisfactory answers to my questions and requests for additional information, (4) will disclose my medical history and conditions truthfully and entirely to the practice, and (5) will inform the practice promptly of any change in my health or symptoms or any complication of treatment. (6) Voluntarily agree to participate in the research protocol. I further agree to indemnify and hold medical providers harmless with respect to any cost, claims, damages, or expenses (including attorneys fee) that may incur in connection with (a) a breach by me of any of the terms of this Consent, and (b) any adverse or undesirable outcome of any kind in connection with my receipt of any products or services generally or specifically described in this Consent. I will receive a copy of this signed and dated Consent sent to my email address on file. 

Dated: Signature of Patient or Legal Guardian giving Informed Consent: Signature: ________________________________________________________ Name: ___________________________________________________________ Address: _________________________________

City: _____________________________________ State: ________ Zip: ____________ Mobile Phone: __________________________________________________ Email: ________________________________________________________ Witness Signature: Witness Name: __________________________