Orthopedic Stem Cell Use Soared in 2012

When 2012 began, an estimated 1 million U.S. patients had been treated with stem cells over the course of the previous 15 years. By the end of 2012, Orthopedics This Week estimates that that number of patients treated rose by an astonishing 100, 000!

Physician users now number in the thousands. Indeed, it is harder to find physicians who have NOT used stem cells than those that have.

Who is using stem cells? Where are they getting the cells? For which indications are cells being used? What is appearing in peer review literature?

Answering those questions is, in effect, the curriculum for this year’s New York Stem Cell Summit – February 19th.

As we have analysed the remarkable uptake of stem cell treatments in orthopedics, we are left wondering…is this, in effect, the next generation platelet rich plasma (PRP)?

Users

Spine surgeons, ophthalmologists and wound care specialists are currently the most frequent users of stem cell therapies in the United States. Coming up fast, however, are oncologists, cosmetic surgeons and pain management specialists.

Spine surgeons and sports medicine specialists are the two groups we’ve observed, exhibiting strong adoption patterns and pushing this remarkable uptake in stem cell usage. One common attribute we’ve noticed is that users of stem cell therapies are also current (and former) users of Infuse and various allograft products.

So, as a foundation for bringing stem cells into their practice, these physicians are almost universally well trained and well experienced in the use of either allograft or recombinant products as adjuncts to surgery which serve to augment the patient’s own ability to grow either bone or soft tissue.

To most of these physicians, stem cells appear to represent a new source of growth factors—and in that context are logical extensions of such well characterized materials as demineralized bone matrix and Infuse. But, of course, stem cells are not well characterized. Yet their growth is exploding among spine and sports medicine physicians.

Ironically, insurance companies and the FDA are two of the primary drivers of this trend. Insurance companies or hospitals who have tried to limit the use of Infuse have driven many spine surgeons to look for biologic alternatives.

Seven years ago the first cadaveric-based stem cell products came to market. With zero reported adverse events so far, these allograft-based stem cell products are increasingly considered to be safe and reliable sources of growth factors by the physicians who use them.

The FDA, which continues to make it more difficult for new spine technologies to come to market, has also contributed to this trend by, in effect, leaving autologous and allograft biologic strategies as increasingly attractive avenues of innovation.

Neurosurgeon “Ty” Thaiyananthan, M.D., (UCSF medical school-trained, Yale residency and founder of the BASIC spine network of clinics in and around Los Angeles) speaks for most spine surgeons when he says: “I really think that spine surgery will be focused on regenerative medicine in the future. We will be looking into stem cells to fix problems that typically require big surgeries. I think that spine surgeons in the future will do more procedures through a needle instead of using the scalpel.”

In his practice Dr. “Ty” openly advertises his stem cell therapies for spine patients as part of an overall treatment plan which includes such traditional spine surgeries as fusion, micro-discectomies and scoliosis treatment. Get more information on Dr. Ty here.

At the New York Stem Cell Summit the co-founder of Rocky Mountain Associates—one of the leading independent spine treatment clinics in the United States—and inventor of Medtronic’s Maverick motion preserving disc replacement, Kenneth Pettine, M.D., will present his experience with stem cell treatments for spine patients. Dr. Pettine has treated, we estimate, around 100 patients with stem cells and is seeing remarkable results.

Down the road from Dr. Pettine’s clinic is one of the world’s most famous sports medicine clinics—the Steadman Clinic in Vail, Colorado. Richard Steadman, M.D., is the legendary founder of this clinic which treats Olympic athletes as well as the famous and not-so-famous weekend warriors. After extensive testing in animal models, he is launching a stem cell practice for his orthopedic patients.

These are not trivial decisions by these leading physicians and clearly points to a powerful and growing trend.

In our opinion, the percentage of spine surgeons who are now incorporating stem cell treatments in their practice is probably between 30-40% of all spine and neurosurgeons.

By way of precedent and comparison, the percentage of ophthalmologists who use stem cells is close to 100%.

The Ophthalmology Precedent – a Model for Orthopedics?

Limbal stem cell transplants were the first autologous stem cell transplant used in the 1970s. In this procedure stem cells are taken from the healthy eye of the patient or a live donor (usually a sibling or a parent). During this outpatient procedure stem cells are harvested from the healthy eye or the donor's eye and then transplanted to the affected eye.

Sound familiar? This is almost exactly the procedure for autologous stem cell treatment by spine or sports medicine physicians who are currently using autologous stem cell systems.

If the transplant is successful, the stem cells will produce a new layer of epithelial cells in the patient's eye. The success rate of growing the new cells from transplanted stem cells varies from 25% to 70%, depending on the underlying condition of the eye.

A stem cell transplant alone can make a patient's vision considerably better. There are about 40, 000 cornea transplants performed each year. Stem cell transplants have been a routine part of modern ocular surgery for more than two decades. Tens of thousands of patients have had stem cells harvested from one eye and then transplanted in the other eye.

According to the literature if a surgeon attempts a cornea transplant WITHOUT stem cells, the cornea transplant nearly always fails.

We estimate that there have been more than 500, 000 autologous limbal stem cell transplants since this technique first gained popularity in the 1980s.

As we observe the uptake of stem cell therapies in orthopedics, frankly we are reminded of the experience in ophthalmology. If the orthopedic use follows this market model, within a few years, virtually all spine surgery and most sports medicine and trauma treatments will employ stem cells.

Where Are Physicians Getting Stem Cells?

There are three sources of stem cells: from the patient (autologous), from cadavers (allograft) or from living donors (allograft).

At this year’s Stem Cell Summit, several companies will be demonstrating their systems for concentrating stem cells from the patient and a number of presenters will be describing allograft stem cell products.

Without doubt, the most successful stem cell product is cadaveric derived stem cells within a bone matrix. These products, which are distributed by Orthofix International, N.V. and NuVasive, Inc., have been terrific for both physicians and patients with both superior safety profiles and efficacy as compared to alternative allograft adjuncts to spine surgery.

Amniotic Tissue

But coming on strong are autologous systems—which are, in effect, upgraded versions of PRP systems with a focus on concentrating stem cells—and living donor stem cell products. Perhaps the most interesting of the living donor products are the amniotic tissue-based products.

One clinic, the BASIC spine clinic with offices in the greater Los Angeles area, has made amniotic stem cell therapies a center piece of their practice and has branded the tissue “inSRT”.

Here is a quote from the BASIC spine clinic web site:

During the stem cell retrieval process, the embryonic and mesenchymal stem cells are taken directly from the amniotic fluid, placenta, and umbilical cord of a healthy, living, consenting donor immediately after the birthing process. inSRT is processed in accordance with protocols and procedures that have been developed to meet or exceed all applicable industry standards for the use of human cellular and tissue-based produces. Unlike other stem cell injections and therapies, inSRT has no negative affect on life or the birthing process. We believe the use of live and healthy donors provides a better approach to regenerative medicine. Injections are done in-office and recovery time is a minimal.

“Both FDA registered tissue banks work closely to adhere to all regulations and industry standards regarding HCT/P recovery, processing, storage, labeling, packaging, and distribution. Each lot of processed human tissue must be determined suitable according to FDA regulations by a Medical Director. inSRT is derived from live, healthy donors during childbirth and provides viable human tissue for clinical use.

The founder of the BASIC spine clinic is G. “Ty” Thaiyananthan, M.D., who is originally from Oklahoma. He earned his Bachelor of Science degrees (Biomedical Engineering and Electrical and Computer Engineering) from Johns Hopkins University. Dr. Ty’s medical degree is from the University of California, San Francisco and he completed his general surgery internship and neurosurgery residency at Yale New Haven Hospital where he was also named Chief Resident of Neurological Surgery. Dr. Ty completed his minimally invasive and complex spine surgery fellowship at Cedars-Sinai Medical Center’s Institute for Spinal Disorders.

The New York Stem Cell Summit February 19th

This will likely be the most significant New York Stem Cell Summit in eight years since it will be capturing and describing a true treatment revolution as it is occurring. The speakers this year and the manner in which this meeting has been organized will teach attendees about the specific technologies, the indications where stem cells are achieving their strongest uptake and the outcomes observed so far. With just three weeks remaining before the meeting, it is time for all interested physicians to sign up before space is gone.