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Are Stem Cell Treatments FDA Approved?

Are Stem Cell Treatments FDA Approved?

Regenerative medicine and stem cell treatments may be fairly well-known amongst the general public, but how much do you know about the regulations of stem cell treatments? Well, for starters, let us quickly clear the air and say that stem cell treatments are legal. But there are other nuanced questions and misunderstandings within this topic. We’re here to break it down for you.

The FDA Only Approves/Denies the use of Drugs and Medical Devices 

One of the first questions many people ask is: are stem cell treatments “FDA-approved”? First, we want to clarify that the FDA only approves and denies the use of drugs and medical devices. Autologous stem cells – which are done in same-day procedures – do not fall in either of the “drug” or “medical device” categories. This is why we cannot say that stem cell treatments are FDA-approved. The FDA can only approve of “stem cell-based products.”

There is a Difference Between Autologous Stem Cells and “Stem Cell-Based Products”

As we mentioned, the FDA cannot approve of autologous stem cells used in same-day procedures. This is because these stem cells undergo minimal manipulation and delivered back to the patient within hours. However, the FDA does regulate “stem cell-based products.” What does this mean? These cells are also not autologous, meaning that they may come from a variety of different donated sources. They may also be cultured or processed by a lab for commercial use before distribution.

The FDA Does Not Regulate the Practice of Medicine

The practice of medicine refers to a physician’s and patient’s ability to freely to consider their chosen course of treatment. All of our procedures regarding regenerative medicine follow the guidelines for cellular therapy published by the FDA. Our choice of treatments, whether it include the use of stem cells or otherwise, are dependent on individual patient’s needs.

There is Overwhelming Support to Keep the FDA Out of Autologous Stem Cell Treatments

Those who are aware of the issues surrounding stem cell procedures have voiced concern about what it might mean to regulate autologous stem cells. While everyone recognizes that there is a need to ensure proper safety and handling of biologics, there is also a strong belief that there is no role for more aggressive government regulation when it comes to what patients are permitted to do with their own body. Many people just find it hard to accept that tissue from their own body needs to be treated as if it were a drug. And there are long-term precedents to support this point of view. For example, skin grafting in burn victims and egg harvesting in fertility clinics have been using autologous biologics for years.

We specialize in regenerative medicine that has proven to be beneficial to patients both young and old. Contact us today to set up an appointment. 1-888-885-HEAL/4325 (toll-free)

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Find Joint Pain Relief With Regenerative Medicine

Find Joint Pain Relief With Regenerative Medicine

Living with joint pain can put a damper on so many everyday activities. Simply walking up the stairs or enjoying a friend’s wedding band can seem impossible. If you haven’t found medical help, it may be time to consider regenerative medicine as your form of joint pain treatment. You may be wondering what exactly regenerative medicine means. It simply means that we use some of your own body’s tissue to help heal disease and injury. Here at New Life Medical Group, we use primarily 3 main regenerative therapies. Check out the below information about how each of these therapies can help you.

Stem Cell Therapy

Stem cell therapy focuses on delivering stem cells to parts of the body that are in need. Adipose tissue (fat cells) or stem cells taken from bone marrow are removed from the patient’s own body. The tissue is made into a stem cell concentrate and injected at the focal point of treatment in the patient’s body. Once the stem cell concentrate has entered the treatment site, they begin the regeneration process. These cells have been found to have immunomodulatory characteristics. They reduce inflammation by inhibiting T-cell activity and the chemical signals that arrive on the scene of an injury or disease process.

Platelet Rich Plasma

Platelet rich plasma (PRP), or platelet concentrates have been studied extensively since the 1990s. While similar products previously used in medicine (fibrin glue) were very expensive, PRP provided a cost effective alternative. Plasma concentrates are a way to help the body finish the healing process and strengthen the weakened tissue. It is used for tendinopathies (tendon problems), in addition to problems with ligaments, muscles, meniscus, cartilage, bone, wound and intervertebral discs.

Prolotherapy

Prolotherapy (short for proliferative therapy) is one way to restart the healing process. Prolotherapy and the above mentioned PRP are both nonsurgical reconstructions to heal joint pain and joint instability. It begins a chain reaction of events that signal the body to focus on the area again. Prolotherapy is most efficacious with a torn ligament (tendonosis). Accidents, sports injuries or just plain wear and tear can cause pain from unstable/worn ligaments and tendons. Prolotherapy will not work on complete tears but in individuals with partial tears or unstable ligaments, it can help them avoid surgery. Prolotherapy can be augmented with PRP (platelet rich plasma) and hyperbaric oxygen therapy.

Stem Cell Therapy, Platelet Rich Plasma, and Prolotherapy can be augmented with Hyperbaric Oxygen Therpay.

We specialize in regenerative medicine that has proven to be beneficial to patients both young and old. Contact us today to set up an appointment. 1-888-885-HEAL/4325 (toll-free)

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Stem Cell Therapy: Sorting Out Fact from Fiction

Stem Cell Therapy: Sorting Out Fact from Fiction

Stem cell therapy is a regenerative medicine that helps relieve pain and aids the body in healing itself. It’s not widely recognized, as many are people still learning how the whole process works, and what makes it so efficient.

As with many new breakthrough sciences, there are a lot of misconceptions about stem cell therapy that need to be cleared up. Patients and critics alike need to be educated about regenerative medicine so that more advances can be made in this arena. Let’s take a look and sort the facts from the myths.

Myth: Stem cell therapy doesn’t help to relieve pain.

Fact: Not only does stem cell therapy work to relieve pain, but it also promotes natural healing from within. Stem cells aid in the regeneration and repair of damaged tissue. Many patients report a substantial level of relief after the therapy.

Myth: Surgery is a more useful, reliable source of pain treatment than stem cell therapy.

Fact: This couldn’t be further from the truth. Surgery is invasive and risky for the patient. Recovery time after surgery is lengthy, not to mention the pain and soreness that patients experience. Stem cell therapy is performed as an outpatient procedure and downtime is minimal. There’s no risk of developing blood clots or infection as opposed to surgery, and most patients find that they are good candidates for this treatment.

Myth: All stem cells come from embryos.

Fact: Stem cells can derive from embryos, but in the vast majority of treatments, specifically for pain, the stem cells are harvested right from the patient’s body. These cells live within our body, so there’s no need to use biological material from outside sources.

Myth: Stem cells are painfully extracted from bone marrow.

Fact: Yes, it’s true that some stem cells originate from bone marrow, however, this procedure is not painful. Patients are given a numbing medication that makes the process very easy to endure. Also, stem cells are taken from fat tissue, not just bone marrow. In fact, most treatments use cells extracted from adipose fat tissue.

Myth: Real doctors don’t support stem cell therapy.

Fact: Stem cell therapy has gained traction among the medical community as a whole, thanks to the support of “real doctors” who perform the procedure, and documents the case studies. The physicians who endorse this therapy are board certified professionals who realize the importance of utilizing treatments that support the body’s natural ability to repair itself.

These are just five of many myths associated with stem cell therapy. The truth is that there will always be some fiction surrounding this topic, but with proper education, people can become aware of the benefits of stem cell therapy and begin to see this as a viable solution to pain issues.

You don’t have to suffer from chronic pain. We specialize in regenerative medicine that has proven to be beneficial to patients both young and old. Contact us today to find out if you’re a good candidate for this stem cell therapy. 1-888-885-HEAL/4325 (toll-free)

 

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5 Reasons You Need To Try Hyperbaric Oxygen Therapy

5 Reasons You Need To Try Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT) is a cutting edge form of therapy that promotes natural healing. This non-invasive treatment method has proven to be beneficial for many different conditions, and is the only non-hormonal treatment that is FDA approved for regenerating human tissue. Candidates for oxygen therapy enjoy easy and painless treatment that relieves symptoms of inflammation, infection, aging, decompression sickness, gangrene, and more.

Hyperbaric oxygen therapy is a form of oxygen therapy that utilizes pure oxygen and atmospheric pressure changes. While this may sound intense, the process is simple (and the experience is soothing!). A patient relaxes in a sealed chamber with a large window that lets them see outside of the chamber. The atmospheric pressure in the chamber is gradually increased while 100% pure oxygen floods the chamber. The patient may experience subtle changes in breathing rhythm, but most people report a peaceful, almost Zen-like experience during their treatments. Read on to discover the top benefits of hyperbaric oxygen therapy.

Restorative

Hyperbaric therapy can be instrumental in restoring a patient’s body to its healthy state after an accident or physical trauma. Patients injured in car accidents and other incidents find relief from the pain and inflammation associated with accident-related injuries. The therapy can also help patients fighting bacterial infections.

Regenerative

Hyperbaric treatments can offer long-term, regenerative results for patients with certain conditions. Hyperbaric oxygen therapy is sometimes accompanied by stem cell therapy because the results can be similar: the oxygen rich environment promotes the body’s natural regenerative process by increasing stem cell production. This can help damaged tissues heal.

Researched

Research related to hyperbaric oxygen therapy has been ongoing for decades, and continues to advance as it gains recognition by the international medical community. Although the research conducted on the performance of hyperbaric chambers varies between different hyperbaric chamber brands, solid data has been gathered to confirm the effectiveness of treatment for a diverse range of conditions, including inflammation from injuries, thermal burns, decompression sickness in divers, diabetic wounds and other wounds that won’t heal, carbon monoxide poisoning, and others.

Relaxing

Hyperbaric treatment is as gentle as it is effective, which is why patients with mild ailments take to the chamber as well as those with serious conditions. Patients suffering from chronic pain find relief from oxygen therapy, and also find the process soothing and even meditative. Hyperbaric oxygen therapy also helps men and women who are looking for a non-surgical anti-aging solution. Ongoing hyperbaric treatments can provide similar anti-aging benefits as harsh injectables, such as Botox. The difference between the believability of the results (and the price tag!) falls in favor of hyperbaric oxygen therapy.

Safe and Realistic

Hyperbaric chambers are only operated by licensed technicians. These state of the art chambers and their accompanying software require in-depth knowledge of the machine and its effects, so patients can relax in the chamber knowing they’re in good hands. The practical benefits of hyperbaric oxygen treatment include affordability (the session costs for hyperbaric therapy are far less than other advanced medical treatments), convenience (patients only need to sit and relax in the chamber for the treatment to be effective), and a minimal time commitment (sessions typically last up to an hour, sometimes less).

Not many medical practices offer hyperbaric oxygen treatment, but residents near Jackson, TN have the opportunity to experience this unique treatment for themselves at New Life Medical Group. Call us today at 731-660-2056 to schedule your first hyperbaric oxygen appointment!

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