Regenerative Medicine in Fort Wayne

Stem cells are the raw material from which all other cells in your body “stem” from, including cells with specialized functions. Stem cells help your body to grow and rejuvenate by producing new cells as your body develops, replenishing old cells, and regenerating new cells to replace damaged tissue. According to your body’s requirements or with the right conditions in a laboratory, stem cells divide to form more cells known as “daughter cells”.

Daughter cells may become new stem cells or differentiate into specialized cells. This differentiation process allows stem cells to contribute new tissue to any organ system in the body or any specific or specialized functions, such as bone cells, heart or skeletal muscle cells, brain cells, and blood cells.  Differentiation is one the most crucial aspects of stem cell treatments because the cells become what the body needs to heal.

The unique capacity of stem cells to naturally generate new cell types is referred to as pluripotency. This amazing potency is unmatched by any other cell in our bodies. A potency or potential which holds great promise to cure diseases by safer means; without toxic pharmaceuticals or destructive surgeries. While more scientific investigations are required to determine the safe, most beneficial and ethical applications of stem cell therapies, the emerging field of regenerative medicine (which employs stem cells and other biologic media) has already demonstrated encouraging outcomes.

Scientists envision a bright future for stem cell therapies based on: their pluripotency, the fact that bone marrow transplants (which involve transplanting bone marrow derived stem cells from a donor to a host patient) have been successful in treating patients with various forms of cancer for over a half a century, their paracrine effects (which we discuss later), as well as the positive outcomes of many related clinical trials and applications.

In other words, we know that stem cells work. Applying them successfully in other ways beyond bone marrow transplants requires more research effort. Consequently, there is intense research directed at the role of stem cells in:

• repairing diseased tissue,
• the physiological and environmental factors necessary for stem cells to mature and thrive,
• how they might compete against or eradicate disease in every organ (e.g. nerves, heart, liver, lungs, bones and muscles), and
• even how to unlock in our bodies the same amazing regenerative capability that allows a salamander, the great horned toad, an octopus or starfish to completely replace an amputated appendage.

Many people can benefit from stem cell therapies, such as those with spinal cord injuries, Parkinson’s Disease, type 1 diabetes, Alzheimer’s disease, amyotrophic lateral sclerosis, osteoarthritis, cancer, burns, stroke, and heart disease.

Instead of having to harvest healthy stem cells from an individual donor, research and clinical trials are underway demonstrating how in a laboratory setting the pluripotency of stem cells as well as their innate propensity to replicate can be exploited to continually propagate new healthy tissue of any organ system. In a specialized laboratory, stem cells can then be used on demand.

Human stem cells have been used to test new drugs to ensure that they are safe and effective. In fact, we’re now starting to use stem cells that were programmed into tissue-specific stem cells for testing. For example, nerve cells can be generated to test medications for nerve disease.

Recognized sources of stem cells include embryos, amniotic fluid, umbilical cords, adult bone marrow, and adipose tissue.

Embryonic stem cells come from embryos just three to five days old. At that point, they’re called a blastocyst and have 150 cells. Their origami-like capacity to turn into any of the body’s 200 mature cell types is particularly tantalizing to scientists. Consider how scientists could enlist their versatility for the repair and regeneration of any damaged organ system or to study the basic science behind what determines a cell’s destiny – – why one cell becomes brain tissue and another one heart tissue.

Adult stem cells are found in smaller numbers (routinely harvested from bone marrow or adipose tissue) and lack the same potency of embryonic stem cells. In fact, researchers believed that adult stem cells only created similar types of cells. For example, if the stem cell was in bone marrow, it could only make blood cells. Yet comparatively they have much less associated risk than embryonic stem cells – particularly when harvested from one site in a patient and applied to another site for treatment in the same patient. Their safety has been evidenced through their use for over half a century in the form of bone marrow transplants.

New evidence suggests that while adult stem cells may not be capable of replicating all cell types (like embryonic stem cells) they can duplicate multiple cell types (i.e. multipotency). As an example, bone marrow stem cells could create heart muscle cells or bone cells. More laboratory testing and clinical trials are required to ensure the usefulness and safety of these new adult stem cell applications.

Scientists have also successfully transformed a regular adult cell into a stem cell through genetic reprogramming. They alter the genes to act similarly to embryonic stem cells, yielding a cell referred to as an induced pluripotent stem cell or iPS. This is a new technique that could help doctors use adult cells instead of embryonic ones to prevent unwanted genetic expression, cancerous transformation, or immune system rejection, though scientists aren’t sure if there might be adverse effects yet.

Perinatal stem cell research is also happening. The umbilical cord blood and amniotic fluid have stem cells that could change into specialized cells. Cells derived from embryos, umbilical cords, or amniotic fluid represent the greatest source of related controversy

In the 1975 Asilmolar Meeting fear of a Frankenstein like creature crawling out of a seedy lab led to a moratorium on recombinant DNA (DNA or human genetic molecules fabricated in a laboratory). Fear that is now widely recognized as excessive, but the consortium of scientists at the 1975 meeting did provide important guidelines for safe biotechnology, including some that apply to stem cell science today.

The NIH (National Institutes of Health) created some guidelines for stem cell research in 2009. They defined an embryonic stem cell and provided some parameters on how it can be used for research, including donation procedures. Recently the FDA approved the clinical application of umbilical cord blood therapies for some cancer and immune disorders. Researchers and clinicians alike have found the current guidelines from regulatory agencies to be somewhat unclear. For example, the FDA has never contested the use of bone marrow transplantation for nearly 6 decades, but has never formally approved them.– – Leading Harvard scientists in 2017 to call for better rules to guide research on embryoids (clusters of dividing pluripotent embryonic stem cells resembling an embryo). Scientists and clinicians are hoping to be a part of advancing bioengineering with reason versus fear, but as of yet, there is no clear path forward or consensus between the science, the clinicians (e.g. physicians applying the science to patients), and the regulatory agencies (such as the FDA).

The general public also looks at the topic of embryonic stem cells with considerable skepticism.  Human embryonic stem cells are gathered from early-stage embryos, which are a group of cells that form when an egg is fertilized with sperm (in the present context this usually refers to an in-vitro fertilization clinic procedure). Since they are removed from human embryos, many issues  have been raised regarding the ethics of embryonic stem cell research.

Accordingly, in 2010 a federal court banned the funding of stem cell research. A decision which was overturned a year later by a panel of appellate judges (Mears, 2011).

Some opponents of abortion do not support stem cell research because of the process involves discarding the embryos after obtaining the stem cells. They advocate for adult stem cell research as it does not involve embryo disposal.

Conversely, scientists observe that a ban on embryonic stem cell research would severely hamper the promise that bioengineering and regenerative medicine hold to cure some of the most deadly and disabling health conditions such as diabetes, cancer, spinal cord injuries and Parkinson’s disease. They submit that by sacrificing a few stem cells, hundreds of thousands of people worldwide could benefit. Moreover, in many instances the embryos are destined for disposal in the first place; predetermined by fertility clinics or hospitals.

For example, Dr. James Thomson, a scientist who isolated human embryonic stem cells in 1988, struggled with the same dilemma. After consulting ethicists he decided to continue his stem cell investigations, particularly because the embryos were from fertility clinics and would be disposed of anyway. Dr. Thomson reasoned that the potential benefits to humanity outweighed the risks.

Yes, non-embryonic stem cell research is actually outpacing embryonic stem cell research. As induced pluripotent stem cells (iPS) have many of the same attributes of embryonic stem cells (without the aforementioned ethical concerns regarding their isolation or creation) most laboratories have shifted their focus to iPS. Moreover, practically any person or tissue is a potential source, creating more abundance and efficiency while demanding less expense. As a result, adult stem cells have become the gold standard for laboratory testing and clinical applications.

Early results of clinical trials have demonstrated promising results in treating:

• neurological conditions (such as stroke, multiple sclerosis, and spinal cord injuries),
• chronic disease (like diabetes)
• as vehicles for targeted genetic therapies (e.g. epidermolysis bullosa, a skin condition).

Despite the growing optimism and hope, scientists still recommend exercising caution as iPS cells, like embryonic stem cells are prone to genetic instability. Mutations or rogue cells could lead to the expression of unfortunate traits, including genetic diseases or tumors. In other words, they recognize the enormous potential but urge the medical field and the public not to get ahead of the science.

Stem cell therapy is part of a broader medical field known as regenerative medicine (RM). RM promotes the repair response for dysfunctional, diseased, and injured tissue using the derivatives of stem cells as well as other biologic media. It’s the next chapter for organ transplantation, featuring cells instead of donated organs.

Researchers can grow stem cells in a lab, and manipulate them to turn into specific types of cells, such as nerve cells, blood cells, and heart muscle cells. Those cells potentially could be implanted into the patient for disease or injury treatment. Imagine that one day a person with heart disease could undergo an injection of healthy stem cells into their damaged heart muscle; transforming the injured heart wall into healthy tissue.

Researchers have indicated that the imaginary possibility is not simply a glimpse into the distant future. In fact, they have already demonstrated that under special laboratory conditions bone marrow stem cells can be transformed to become heart-like to possibly repair heart disease in people, though more testing is necessary.

Yes. In addition to the long-standing use of bone marrow and umbilical cord derived stem cells to help the immune system fight blood-related diseases and some cancer types, a growing number of clinics nationwide offer stem cell treatments for a wide variety of health disorders. The safest and (in most clinical settings) the most effective treatment protocols involve harvesting stem cells from the bone marrow or adipose tissue of the patient to be treated. This process is referred to as an autologous transplant, as the donor and host are one in the same.

Researchers have to ensure that the stem cells differentiate into specific cell types needed. They’ve discovered ways to do this, but more testing is required. For example, embryonic stem cells may grow irregularly and specialize into unintended new cell types. Therefore, researchers must control this undesirable trait of embryonic stem cells before related therapies can safely be applied on a wide scale.

Two looming concerns for immunologists (scientists who dedicate their profession to the study of our immune system) include the potential for cancerous transformation  (transplanted cells turning into cancerous cells called tumorigenicity) and immunogenicity (when cells may not function as they should, resulting in unfavorable consequences, which could include the unexpected expression of a genetic variant, e.g. disease). For example, heart cells derived from embryonic stem cells have been shown to cause arrhythmia or irregular beating of the heart muscle.  Liver, nerve, and blood cells grown from embryonic stem cells often do not function properly as fully mature liver, nerve or blood cells would otherwise be expected to behave.

Accordion Content

Therapeutic cloning is referred to as somatic cell nuclear transfer. The technique creates versatile stem cells that are independent of a fertilized egg. Here, the nucleus gets removed from the unfertilized egg, which contains the genetic material.

The donor nucleus gets injected into the egg, which replaces what was removed. Then, the egg can divide and form the blastocyst. Such a process creates a line that in theory should contain the same DNA (genetic material) as the nuclear donor, but a number of investigations revealed the practical application of that theory is critically flawed, producing stem cells which are not immunologically matching.

Researchers do believe that stem cells derived from this cloning procedure can offer benefits over fertilized eggs. The cloned cells aren’t as likely to get rejected when transplanted back into that donor. This may also help scientists see how diseases develop, but for now, it’s back to the drawing board to unlock the mystery behind the immunological mismatch.

Not yet. Researchers haven’t successfully performed therapeutic cloning on humans. Therefore, they continue to conduct tests in this area.

Mesenchymal stem cells are obtained from different sources. They include adipose-derived stem cells (fat tissue), bone marrow, umbilical cord tissue, and blood, or placental tissue. In fact, mesenchymal stem cells are a large part of regenerative medicine. The most common harvest sites for clinical applications are bone marrow and adipose tissue.

Once the cells are harvested, they are injected into the injured or damaged body part under direct visualization (typically employing ultrasound or real-time x-ray known as fluoroscopy).

Mesenchymal stem cells use signaling, differentiation, anti-inflammatory, and immunomodulatory over self-renewal properties to effect a positive change in the body. MSC’s healing properties largely occur through a process known as a paracrine effect, where they exert their influence on proper tissue repair by signaling other cells to activate behaviors which facilitate healing or warding off disease.

As observed in research efforts, MSCs can be influenced under select laboratory circumstances to self-renew by developing and dividing into various specialized cell types in a specific organ or tissue. As adult stem cells, mesenchymal stem cells do not carry the ethical or controversial baggage of tissues sourced from embryonic material.

There are many therapeutic uses of mesenchymal stem cells for different diseases. Clinical trials with mesenchymal stem cells over the past decade have made stem cell therapy a hot-button topic.

Stem cells have an intrinsic property that makes them “home” or seeks areas of inflammation or low oxygen tension. A characteristic that allows them to find disease and injury targets like guided missiles. Studies indicate that their influence on modulating the immune system and reducing inflammation helps to promote a better quality of life and health.

Stem cell therapy is part of regenerative medicine that repairs damaged tissue and cells in the body by modulating the immune system and reducing inflammation. Overall, stem cell therapy is a viable treatment choice for many medical conditions. In fact, stem cell therapies have been utilized to treat neurological, autoimmune, inflammatory, traumatic, and orthopedic conditions.

Though stem cell therapy doesn’t necessarily offer a cure for such conditions, it can help the body heal itself; mitigating symptoms for longer periods. Many cases show improved quality of life and the ability to delay disease progression.

One type of stem cells, known as mesenchymal stem cells or MSCs, which seem to play a major role in the regeneration of certain tissues (such as bone, cartilage, and connective tissue), may not behave in the same way other stem cells do. Instead of dividing and differentiating, their main effect on healing and regeneration appears to be in their powerful ability to influence our immune system and arrest inflammation; a process known as medicinal cell signaling.

As noted by the recognized father of mesenchymal stem cells, Dr. Arnold Kaplan at the FDA held a public hearing at the Masur Auditorium on the campus of the National Institutes of Health, in Bethesda, Maryland September 12-13, 2016: “This language (medicinal cell signaling) is meant to recognize the ability of MSCs to have strong medicinal effects, while identifying that they do not exert their majority effects by regenerating tissue, but rather by leveraging sensory capabilities, positively affecting the microenvironment, and being sentinels for injury.” – Adding in a recent interview: “Those newly docked MSCs are capable of surveying and sensing the microenvironment in which they find themselves, and they have a programmed response-profile of secretory activity for any given microenvironment. If the microenvironment is inflammatory, the MSCs produce anti-inflammatory molecules. Thus, MSCs are site-regulated, multidrug dispensers that function at sites of injury.”

The experience of researchers and clinicians alike provides evidence and hope that MSC’s may be safer than other stem cell therapies. In part, because they release huge quantities of immunosuppressive biomolecules and erect a fortress of molecules surrounding them. The resultant shield of molecules means the MSCs are immune privileged or immune masked, allowing them to be transplanted from a donor into a recipient, free from an immune response.

While MSC’s do not exert their disease-fighting capabilities in our bodies primarily through self-renewal and differentiation (in contrast to other stem cells) – under select laboratory conditions they can be manipulated to differentiate and replicate. Consequently, such laboratories can be sources for specific types of tissue such as neurons, bone, tendon, muscle, cartilage, liver, heart, or adipose.

One study from 2016 conducted by Almalki found that the differentiation of the MSCs into specific cells is controlled by growth factors, cytokines, transcription factors, and extracellular matrix molecules. These types of investigations provide new avenues for regenerative medicine treatments to contribute to the process of:

• maintaining our bodies’ normal functions,
• its capacity to adapt to harsh or alternate environments, and
• repairing damaged tissue.

There is a growing body of evidence to suggest that adult stem cells can be safely and effectively used to treat neurological conditions, autoimmune diseases, inflammatory problems, and orthopedic issues. Other studies focused on stem cell treatments on COPD, Lupus, multiple sclerosis, Crohn’s disease, stroke, ALS, and more.

It’s important to note that stem cells don’t always offer a cure for a condition. The goal of regenerative medicine is to empower the body through the application of biologic media (like stem cells) to ward off inflammation and help it to heal itself as well as handle the symptoms more effectively. However, this alone can boost the quality of life and prevent long-term disability in people suffering from many health conditions.

Can the Body Reject the Stem Cells?

Stem cells harvested from your own body do not run the risk of rejection, as your immune system already recognizes them.

Mesenchymal stem cells derived from someone else’s tissue are generally considered safe and unlikely to be rejected because as previously mentioned they are immune-masked.

UC-MSCs (umbilical cord mesenchymal stem cells) are sourced from many areas, such as the peri-vascular region, cord lining, and Wharton’s Jelly. Typically, these tissues would otherwise be discarded by hospitals and can be retrieved non-invasively.

They can differentiate into other cell types and have a higher proliferation rate than some other options. Plus, they are similar to bone marrow and adipose tissue because they secrete growth factors, chemokines, and cytokines, which improve cell repair mechanisms.

In a sense, UC-MSCs can be harvested non-invasively and don’t have to be extracted from the patient. They’re taken from ethically donated umbilical cords, so there are no ethical problems. For multiple sound reasons, there is a considerable buzz surrounding the applications of umbilical cord-derived stem cells in the science and medical communities.

Umbilical cord stem cells have been successfully applied to treat a number of disease entities in hospital settings (where the cells are freshly sourced from consenting donors). However, there is little to no evidence to suggest that these cells can be shipped to remote clinics and other destinations while remaining viable (i.e. meet the gold standard of plastic adherence, the capacity to replicate in a petri dish).

At least three recent studies of the umbilical cord and amniotic fluid tissue sourced from commercial laboratories (marketing to medical clinics) demonstrate no evidence of viable or live stem cells. These results in context should not be jarring, considering that once harvested in a public hospital setting the umbilical cord tissues are then:

• stored,
• transported,
• stored again at a processing site,
• processed,
• packaged,
• frozen,
• shipped, and
• shock-thawed (often by the heat of a doctor’s hand at the clinic of their destination).

Yes, stem cell numbers start to decrease and become dormant as a person ages, and they may lose their effectiveness. But take heart, because in contrast to the disappointing performance of commercially marketed umbilical and amniotic stem cells, a recent study by the Translational Medical Institute of Colorado State University demonstrated an abundance of viable stem cells in elderly and middle-aged bone marrow (in contrast to commercially marketed umbilical cord sources). Their study lends credence to the positive outcomes of clinics like Spine Technology and Rehabilitation in the clinical application of autologous bone marrow toward musculoskeletal conditions.

Yes.

PRP (platelet-rich plasma) is one alternative or synergistic treatment option. The alpha granules in our platelets are a rich source of growth factors. Growth factors have many important healing properties including fighting inflammation and up-regulating the vital functions of stem cells. They are obtained through a simple blood draw procedure.

Another tool in the regenerative medicine kit is bioscaffolding, which is lattice-like material often obtained from connective tissue. Bioscaffolding can be used for filling defects within injured tissue to spur healing.

Treatment options offered at spine technology and rehabilitation depend on your needs and the recommendation of the doctor. However, you know you’re getting quality treatment.

Regenerative medicine therapies offered by Spine Technology and Rehabilitation treat a host of musculoskeletal conditions including:

• Foot and ankle
• Knee
• Hip
• Disc
• Neck
• Shoulder rotator cuff
• Hand and wrist
• Elbow

Our goal is to help with your pain management needs in a new and more efficient way. Clinical trial studies have indicated the benefits of stem cell therapy, and our successful outcomes have demonstrated that it works better than most commonly offered solutions.

We can work with your primary care provider to ensure that regenerative medicine therapies are conducted in the context of your overall health needs. Generally, STAR is here to help with spine, muscle, joint, and nerve conditions.

Both PRP and stem cells do a great job of treating pain and inflammation. PRP therapy uses platelets from your blood, instead of stem cells from bone marrow or fat