Regenerative Medicine: The Future Is Here!

Regenerative Medicine: The Future Today

It’s a great time to be getting old. Really!  In large part to the exciting and emerging field of Regenerative Medicine getting old may not be all that bad. Regenerative Medicine will rejuvenate you and in the process revolutionize medicine.

Regenerative Medicine will be the single biggest breakthrough in the history of medicine to date. It represents a disruptive breakthrough that threatens the traditional way of doing things which will delay its acceptance within the medical community.

Let me make a few predictions regarding the future of medicine as we begin the New Year. The future doctor will be a regenerative medicine doctor who happens to specialize in orthopedics, or a regenerative medicine doctor who happens to specialize in cardiology, or a regenerative medicine doctor who happens to specialize in neurology, and so on.

And, here is what will be unique. Each of these doctors will treat the various conditions in their specialty. But, this is what will be fascinating. Each of these specialists use will be the same treatments regardless of their specialty and regardless of the condition being treated. The same Regenerative Medicine techniques will be used in all specialties. This will alter the practice of medicine beyond the simple treatment of disease. It will alter what it means to specialize.

This leads us to my second prediction. Because doctors of all specialities will utilize the same form of treatments the current boundaries that separate one specialty from another will begin to disappear. They will become blurred. There will be more collaboration among specialties, yet more competition between them.

Here’s why. Once a physician gains experience in these regenerative medicine techniques he or she will be able to treat virtually anything. A family practice physician will be able to treat arthritis as well as an orthopedic surgeon. An interventional radiologist will treat spinal conditions as well as a spine surgeon. An internist will treat diabetes as well as an endocrinologist. All of this will be made possible by regenerative medicine. The Regenerative Medicine doctor will have virtually no limit to his/her scope of practice, other than the limits he or she place on himself/herself.

It’s fascinating to go to a Regenerative Medicine conference or workshop and see specialists from all fields – all seeing the future and looking for more effective ways to treat patients. But, far too many physicians will remain set in their ways and will be resistant to change and will get lost in the tsunami coming their way.

Those physicians who resist the inevitable change that Regenerative Medicine will bring about will be left behind.  Surgeons will no longer spend a bulk of their time performing surgery as we think of it today. In the past, surgeons made incisions – large incisions – to operate.

Then technology made it possible for smaller incisions. Now in some surgical fields a bulk of surgery is performed with a thin scope requiring nothing more than poke hole incisions. In the future, a needle with stem cells is all that will be needed in many cases to accomplish much the same.

Resistance to Change in Medicine

The medical establishment dislikes change. I was something like the fourth or fifth internal medicine doctor in the country to complete a formal fellowship in sports medicine. When I decided to go into sports medicine many of my colleagues involved in my residency training looked at me and said, “You’re nuts! Why would you want to do that? You know that’s not real medicine?”

The concept of sports medicine was not well accepted in the late 1980’s within the medical establishment.  Nowadays most sports medicine physicians coming out of training cannot find a dedicated sports medicine opportunity because the field is so competitive and overcrowded. In my day, a physician had his pick of opportunities.

In 2008, I became interested in male hormone replacement and age management medicine. Neither was well accepted 10 years ago. Even today the importance of maintaining optimal hormone levels throughout life is not fully embraced by the medical establishment but the practice of hormone replacement is far more commonplace today than it was 10 years ago.

By the way – hormones help stimulate production of stem cells.

As common sense as it seems, the principles of exercise and nutrition are usually only paid lip service in today’s medicine. Exercise and nutrition are the very keys to health and age management. And, yet they are not routinely used to prevent disease. Traditional medicine would rather treat disease than prevent it.

We are always five to 10 years (at the very least) behind what can be done in medicine. Today’s medicine is always yesterday’s medicine because of the lag time between development and the actual implementation of technology and newer treatments. Being behind – practicing yesterday’s medicine – never made much sense to me, which is why I spend considerable time “skating to where the puck is going” to borrow Wayne Gretzky’s words. I like to be where the future is.

It is now 2018. Guess what? The first published study of successful cartilage regeneration in human knees using autologous (one’s own) mesenchymal stem cells was published in 2008. TEN years ago. We are already 10 years behind what can be done with stem cell therapies.

The future of medicine is filled with promise and hope thanks to Regenerative Medicine.

What is Regenerative Medicine?

Regenerative Medicine uses the body’s own repair and regenerative mechanisms to replace or regenerate diseased or injured tissues to restore or establish normal function. Understanding cell biology is most fundamental to understanding how regenerative medicine techniques work. Regenerative employs the following:

• cellular therapies (stem cells and plasma rich platelets)
• cellular therapy enhancers (drugs and supplements that trigger facilitate cellular function)
• scaffolds (used to repair damaged tissue and even create entire organs)
• gene therapy
• biologics
• delivery systems (ways to deliver tissue healing factors to the site of injury or disease)

Regenerative Medicine may seem like science fiction but consider this. In 2013 3D printing was used to produce clusters of live human embryonic stem cells. Complete organs have been created using stem cells and scaffolds and 3D printing in laboratory animals, too. That is now being applied to humans. Human ears have been created using human stem cells. This is happening – TODAY!

What is happening in regenerative medicine is real and it is spectacular. Every young physician needs to stay on top of this emerging field.

Obstacles to Regenerative Medicine

Here are three potential obstacles I see to Regenerative Medicine.

• Acceptance by mainstream medicine.
• Unclear regulatory environment at the present.
• Little commercial interest.

Acceptance by Mainstream Medicine

We touched on this above. Regenerative Medicine will blur the boundaries of specialties. Physicians typically don’t like others invading “their turf.” The field that Regenerative Medicine will most affect the field of orthopedics, initially. But, will eventually affect other specialties as well.

Cellular therapies will be used to treat arthritis. This will minimize the need for joint replacements. The total cost of a joint replacement cost $25,000 to $50,000 depending on the region of the country. Hospitals make money, medical device companies make money, anesthesiologists make money, surgeons make money, physical therapist make money – they all make money when metal and plastic is put into the body.

None of those entities will make money with stem cell therapies outside the physician who performs the procedure. Therefore, those entities will likely resist embracing regenerative medicine techniques.

Unclear Regulatory Environment

The FDA is charged with regulating drugs and devices (each involves separate regulations). On the surface stem cells would not appear to be a drug or a device. But, the FDA has a much broader definition of what a drug is than you might think. Based on its definition it is possible for stem cells to be considered a drug depending on how the cells are processed and the source from which they come.

During the time I have been writing this the regulatory environment surrounding regenerative therapies has become somewhat clearer and more optimistic. Recently in November, 2017, the FDA announced its Draft Guidance, Expediated Programs for Regenerative Medicine Therapies for Serious Conditions. The following is from page two if this Guidance.

Regenerative medicine is a rapidly expanding field that has the potential to treat serious conditions, particularly in patients with unmet medical needs. CBER recognizes the importance of regenerative medicine therapies and is committed to helping ensure they are licensed and available to patients with serious conditions as soon as it can be determined that they are safe and effective.

* CBER is an arm of the FDA and stands for the Center for Biologics Evaluation and Research.

The FDA has created a new designation for regenerative therapies – the Regenerative Medicine Advanced Therapy or RMAT designation. If certain criteria are met it will be possible for regenerative therapies to be “fast-tracked” for approval.

Until these new announcements by the FDA the regulatory environment was stifling the advancement of regenerative therapies. It now looks like regulatory environment is beginning to change in a positive way.

Commercial Interest

Right now funding for regenerative therapies is limited because there is little financial gain for other stakeholders. This is different than launching a new drug where a drug company will “joyfully” spend a billion dollars on research and development knowing it will more than recoup those costs if the drug gets approved.

Who stands to gain from regenerative therapies outside the patient and physician? Few outside the patient (treatment benefits) and the physician (financial benefits) have anything to gain from stem cell therapies. In other words, there isn’t any big money eager to fund drug approval like studies for stem cells and other regenerative therapies. This has hampered the completion of studies. This is one reason the FDA created the RMAT designation – to facilitate FDA approval of such therapies.

Mesenchymal Stem Cells: The Body’s Natural Drug Store

Here is my last prediction. We discussed in Are Mesenchymal Stem Cells Really Stem Cells? that mesenchymal stem cells (MSCs) are really medicinal signaling cells ( MSCs) – that they are the body’s natural drug store. Stem cells contain hundreds of molecules – growth factors, immune modulators, natural antibacterials, and more.

These molecules act synergistically to create an environment for tissue repair and regeneration.  Once all these molecules are identified along with their proper quantities, I predict pharmaceutical companies will conveniently package them into  a “drug.” At that point there will be commercial interest to fund studies.

Once that happens physicians will no longer have to harvest stem cells from bone marrow or fat like they do presently. If a patient has arthritis of the knee the physician will reach for the the Merck or Pfizer Joint Repair Formula and inject it into the knee. Or, they will reach for Lilly’s Heart Attack Repair Formula which will be injected into damage heart tissue via cardiac catheterization and repair the damaged heart. Or, you sustain a femur fracture from skiing that would require multiple surgeries to reconstruct today. No problem. Some day in the future a new femur will be grown on a 3D printer using stem cells to replace the badly fractured bone.

When all this happens – then we will see an explosion in the field of Regenerative Medicine.

It is not going to happen tomorrow. But, it is going to happen. You just have to stay alive long enough to see it become reality.

Welcome to the future! Welcome to 2018!

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