This position statement was developed by the surgeons of the Bone and Joint Institute of Tennessee after collectively reviewing the most up-to-date scientific studies of biologic therapies. There is an increasing interest in the use of biologic products, including stem cell and PRP therapies, as modalities for treatment of the musculoskeletal system. As orthopaedic surgeons, we must critically analyze the scientific basis for these therapeutic options, including the benefits, risks, efficacy, and the regulatory pathways for approval. Currently many emerging biologic therapies lack a clear demonstration of safety and effectiveness for traditional orthopaedic treatments.
PLATELET-RICH PLASMA (PRP)
WHAT IS PRP?
Blood is made of a liquid called “plasma” and small solid components including red blood cells, white blood cells, and platelets. Platelets contain hundreds of proteins referred to as growth factors, which signal the body’s healing response. PRP contains concentrations of platelets 5-10 times greater than what is found in normal blood.
HOW IS A PRP TREATMENT PERFORMED?
Similar to a lab draw, a sample of blood is taken in the clinic. The platelets are separated from the other cellular components and the concentration of platelets is increased through a process called centrifugation. The concentrated sample is then injected into an area to facilitate healing.
HOW EFFECTIVE IS PRP FOR ORTHOPAEDIC CONDITIONS?
It is hypothesized that the increased localization of concentrated growth factors may potentially speed up the healing process. Research studies are currently being conducted to evaluate the effectiveness of PRP treatment for a variety of conditions, but presently the results of the available studies are largely inconclusive.
- Conditions where PRP shows the most promise and scientific evidence: tendinopathy (such as tennis elbow and chronic patellar tendonitis). Conditions with possible but unproven benefit: osteoarthritis, muscle strain (such as hamstring injury), augmentation of rotator cuff repair.
- Conditions with no demonstrated benefit: ligament tears, meniscus tears, labral tears.
WHAT ARE THE RISKS OF PRP?
- Increased pain at the injection site, infection, tissue damage, and nerve injury due to injection.
- Potential lack of effectiveness.
HOW MUCH DOES PRP COST?
Currently the charge for PRP at the Bone and Joint Institute is $350. You will need to check your eligibility with your health insurance carrier as very few insurance plans provide even partial reimbursement for the treatment.
STEM CELL TREATMENT
WHAT ARE STEM CELLS?
Stem cells can create new cells in both existing healthy tissue and help repair damaged tissue. Mesenchymal stem cells can differentiate into muscle, bone, fat and cartilage. Bone marrow-derived mesenchymal stem cells (BMD-MSC) are most commonly used in orthopedics.
HOW IS A STEM CELL TREATMENT PERFORMED?
Stem cells are most commonly obtained from the iliac crest of the pelvis. A needle is inserted into the bone and samples of the bone marrow are aspirated. The samples are then sent to a lab for processing and amplification. This process may take several weeks. The concentrated sample is then injected into an area to facilitate healing. Stem cells can also be harvested from adipose (fat) tissue, synovial tissue, peripheral blood, and placental tissue. Allograft (donated) stem cells are also now commercially available.
HOW EFFECTIVE IS STEM CELL TREATMENT FOR ORTHOPAEDIC CONDITIONS?
Cell and tissue therapies promoted for orthopedic conditions have been poorly studied and lightly regulated, with small numbers and many studies lacking a control group. There may be promise in the future for biological therapies; however we currently do not have evidence to tell patients they can expect good outcomes and avoid surgery. Stem cell treatments are being developed for bone fractures and nonunions, regeneration of articular cartilage in arthritic joints, and for the healing of ligaments or tendons. Stem cell treatment shows the most promise and scientific evidence for focal cartilage defects in joints, such as the knee. Conditions with possible but unproven benefit include ostoearthritis of the knee, hip, shoulder, and ankle.
WHAT ARE THE RISKS OF STEM CELL TREATMENT?
As stem cells regenerate themselves they can become different cells which may form tumors or cancer cells. While most studies have shown stem cell treatments to be safe, transplanting cells into a different body part from which they originated may have unforeseen risk and unpredictable complications.
- Any cell grown or processed in the laboratory might have genetic damage.
- High cost may not be supported by clinical improvement.
- The FDA currently discourages the use of stem cells except in clinical trials or approved therapies.