Q&A with Don Buford, MD

Don Buford, MD, Director, Dallas PRP and Stem Cell Institute is a board-certified orthopaedic surgeon who has been practicing in the Dallas area for 18 years. He grew up in Los Angeles and attended Stanford University. While at Stanford, he was a member of the baseball team and had a double major in economics and pre-med. He eventually transferred to USC to continue his athletic and academic pursuits.

In 1998, he was awarded the Woody Hayes NCAA Division I Academic All-American Award, which recognized the single most outstanding NCAA Division I male student-athlete. After graduation from USC, he signed his first professional baseball contract with the Baltimore Orioles. At the same time, he enrolled a UCLA Medical School.

After graduating from the UCLA School of Medicine, Dr. Buford completed an orthopaedic residency at UT Southwestern in Dallas. Dr. Buford also completed a one-year sports medicine fellowship at the Southern California Orthopaedic Institute.

Dr. Buford’s practice includes a specialization in non-surgical orthobiologic injections for orthopaedic conditions such as joint pain, back pain, and sports injuries.

The following is a Q&A that TOA performed with Dr. Buford on the stem cell issue.

TOA: Can you talk about the promise of stem cells in orthopaedics? How could they improve the treatment of orthopaedic conditions?

DB: Advances in orthopedics over the past 125 years have primarily resulted from advances in materials, implant design, and surgical techniques.  We are now at an exciting time in orthopaedics where we are learning how to repair and restore the musculoskeletal system by using human biology.  As orthopaedic physicians, our goal is to return the body back to its pre-injury or pre-dysfunctional state.  For many orthopaedic conditions we have reasonable nonsurgical and surgical options to accomplish our goal.  However, after 150 years of modern orthopedics, there are many orthopedic injuries and degenerative conditions where our current solutions can still be significantly improved.

The allure of using stem cells and human biology is that we can better restore the body to its pre-injury or pre-dysfunctional state by harnessing biology that all of us have access to already.  In the near future there may be many conditions where our understanding of stem cells and human biology gives us a treatment option better than current nonsurgical and surgical choices.  There may also be situations where surgical outcomes can be improved by using stem cells and human biology at the right time and in the right “amounts” to get a superior outcome to surgery alone.  A lot of the basic science and translational research is ongoing and being clinically evaluated right now …. making this an exciting time to be a physician specializing in orthopaedics.

TOA: How are stem cell treatments effective? What are the potential risks or side effects?

DB: In my opinion, there continues to be some misperception regarding what stem cells actually do in current orthopedic clinical treatments.  In the lab, there are ways to make stem cells differentiate into many different orthopaedic tissues, and, in fact, this is one of the ways that we identify harvested cells as stem cells.  However, once injected into the body, stem cells do not simply differentiate into tissues as might be suggested by what happens in the controlled lab environment.  Stem cells make proteins called cytokines that have many effects on cell communication and control of our body’s healing response.  In fact, many researchers and clinicians now believe that it is the production of appropriate cytokines in an area of orthopaedic injury or degeneration that is the most important role of stem cells.  The most important role of the stem cell in orthopaedic applications may be to function as the producer and manager of the local cytokine environment.  For example, I never tell patients that a stem cell therapy will regenerate the cartilage in an arthritic joint, and, in fact, I think we are doing patients a disservice if we are giving them that expectation.  However, I do think it is currently accurate to counsel patients with arthritis that a stem cell injection can give them years of significant pain relief and possibly even slow the progression of arthritis.  There is good clinical data supporting the effectiveness of stem cells for restoring discrete cartilage defects in a joint, but it still isn’t appropriate to conclude that an arthritic joint can be restored “like new” with current stem cell treatments.  Wherever we are injecting stem cells, it is likely their local cytokine production that is the more important feature that is giving good clinical results.  Of course, some cells may be “transforming” into other tissues, but overall I think the current orthopaedic thought trend is that stem cells have their biggest clinical impact by modifying the local healing environment.

Orthopaedic physicians are continuing to do clinical research to show effectiveness and to compare stem cell therapies to other established alternatives.  For degenerative orthopaedic conditions like knee arthritis there is mounting published evidence that a stem cell therapy can provide pain relief and some functional improvement to patients who don’t have other better options.  Although we have the potential to impact nearly every orthopaedic condition by using stem cells, the human clinical trials to prove success are only now being designed and started for many orthopedic conditions.  There will be more interest and earlier published results in those areas where current treatment options leave significant room for improvement or that affect a larger number of people.  Arthritis will be at the forefront for ongoing research because it is a universal orthopedic condition responsible for disability and a source of significant expense for society.

The good news is that many independent researchers have published on the safety of bone marrow and adipose derived stem cells in orthopedic uses. However, current regulations in the USA preclude the use of adipose derived stem cells in orthopedics without significant additional regulatory approval so we continue to use bone marrow as our source for stem cells.

For orthopedic uses where the cells are injected into a joint or into soft tissues such as ligament, tendon, muscle…these procedures have been shown to be very safe with minimal risk of infection or disease transmission since the cells are from the same patient (autologous).  In the United States, we cannot culture stem cells or bank stem cells and give them back to the patient without significant additional regulatory approvals.  As a result, we give patients back their stem cells on the same day and this is a very safe orthopedic procedure.

TOA: Can stem cells regrow cartilage in a joint with arthritis?   If not, what evidence is there that stem cells are useful for cartilage injuries?

DB: For a defined cartilage defect, there are excellent clinical studies supporting the conclusion that the stem cells need to be held in the defect with a “patch” or a biologic scaffold.  Orthopedic surgeons have been using autologous chondrocytes for cartilage lesions for nearly two decades.  However, the procedure required 2 surgeries and was technically challenging and was expensive.  More recently we have an allograft chondrocyte product (cartilage cells) on the market in the USA that also requires a biologic glue to hold the cells in place in the cartilage defect.  This new option eliminates the need for a second surgery and is cheaper than the prior solution with autologous cultured cartilage cells.  In Italy, there has been exciting clinical research showing restoration of articular cartilage defects in the knee by using a scaffold soaked in autologous stem cells and placed in a single surgical procedure.  The results were followed for a minimum of two years and the success rate is above 80%.  The exciting aspect of using stem cells for cartilage injuries is that the cartilage that regrows appears to be nearly identical to normal articular cartilage.  The scaffold used to hold the stem cells in place in the cartilage defect is currently in clinical trials in the USA and if approved it will be more evidence of how we can use stem cells in conjunction with surgery to actually lower cost even further and improve outcomes for patients.   In the outpatient, nonsurgical setting, we don’t have a way to hold the stem cells in position in a defect so most outpatient research and treatments are for patients with more generalized cartilage loss as seen in arthritis.  There are other surgical concerns and options for treating patients with cartilage injuries, but the prospect of using autologous stem cells as a major part of future treatment is exciting.

TOA:  Is harvesting patient’s stem cells one of the hurdles that is hindering their widespread use? Are stem cells obtained from donors safe for recipients? 

DB: In my clinic, we harvest bone marrow to make a stem cell injection in a safe one hour procedure done under local anesthesia and ultrasound guidance.  We have done many hundreds of these procedures in the office which makes it convenient and less stressful and more affordable for patients.  As a result, I don’t think the hurdle of harvesting stem cells should hinder their widespread use.

In the USA, the are several factors that limit the more widespread use of stem cells in orthopaedics:

  1. There is a lack of published human outcome data comparing stem cell therapies to current established therapies.
  2. Stem cell procedures are not covered by insurance.
  3. Stem cell procedures are relatively expensive to the patient….the average cost for one joint in the USA is about $4000.
  4. The legitimacy of stem cell therapies has been hurt by the rise of retail “clinics” in the US selling amniotic and umbilical cord products as a “stem cell” therapy.  These clinics either violate FDA regulations on allograft living cell transplants or in fact do not have living stem cells when given to the patient.  Unfortunately, as these clinics are continually exposed, the media and patients get the message that all stem cell procedures are “shams”.

For clinicians with no training in harvesting bone marrow, training and mentoring is necessary to make sure they understand how to do an effective bone marrow aspiration and concentration to maximize stem cells and cytokines and to minimize the red blood cells in the final product.  Based on established human biology and published human outcome studies, I strongly believe that the best bone marrow stem cell product requires centrifuging the bone marrow in a process that takes about 12 minutes in the office.

The use of stem cells harvested from donors, so-called allograft stem cells, may be safe for recipients but in my opinion the risk profile must be clinically well defined first. Doctors and patients need to know exactly what the risks and benefits are for an allograft stem cell procedure in order to properly judge when to use it.  We need to ensure safety and we need to ensure that the transplanted cells will not bring any risk of infection, rejection, or tumors.  There are many ethical concerns surrounding embryonic stem cells and their overall safety may be harder to define.  As a result, researchers are looking at other ways to “make” or “reprogram” other cells in our bodies to become stem cells.  One day we may not need to harvest bone marrow to get stem cells but rather could take a small skin sample and simply reprogram the cells into stem cells.  The future direction of orthopedic stem cell therapies will be exciting to watch as more of the basic science is translated into proven clinical treatments.