A variety of growth factors have been found to play a role in wound healing, including platelet-derived growth factor, epidermal growth factor, fibroblast growth factors, transforming growth factors, and insulin-like growth factors.
Topically applied platelet-derived growth factors (PDGF) have been most extensively investigated for clinical use in wound healing. A recombinant PDGF product, becaplermin gel (Regranex®, McNeil Pharmaceutical) is approved by the U.S. Food and Drug Administration (FDA). The labeled indication is as follows:
"Regranex Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, Regranex Gel increases the complete healing of diabetic ulcers. The efficacy of Regranex Gel for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers has not been evaluated."
Autologous (related to self) PDGFs have also been investigated as wound healing products. For example, platelets are a rich source of PDGFs, transforming growth factors (which function as a mitogen for fibroblasts, smooth muscle cells, and osteoblasts), and vascular endothelial growth factors. Autologous platelet concentrate suspended in plasma, also known as platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood. Exposure to a solution of thrombin and calcium chloride results in the polymerization of fibrin from fibrinogen, creating a platelet gel. The platelet gel can then be applied to wounds or may be used as an adjunct to surgery to promote hemostasis and accelerate healing. Activated platelets then degranulate, releasing the various growth factors. There is a number of commercially available centrifugation devices used for the preparation of PRP. For example, AutoloGel™ (Cytomedix) and SafeBlood® (SafeBlood Technologies) are two related but distinct autologous blood-derived preparations that can be prepared at the bedside for immediate application. Both AutoloGel and SafeBlood® have been specifically marketed for wound healing. Other devices may be used in the operating room setting, such as Medtronic Electromedic, Elmd-500 Autotransfusion system, the Plasma Saver device, or the Smart PreP device. In the operating room setting, PRP has been investigated as an adjunct to a variety of periodontal, reconstructive, and orthopedic procedures. For example, bone morphogenetic proteins are a type of transforming growth factors, and thus PRP has been used in conjunction with bone replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries. In addition, platelet-rich plasma has also been proposed as a primary treatment of miscellaneous conditions, such as epicondylitis, plantar fascitis, and Dupuytren’s contracture.
Platelet-rich plasma must be distinguished from fibrin glues or sealants, which have been used for many years as a surgical adjunct to promote local hemostasis at incision sites. Fibrin glue is created from platelet-poor plasma, and consists primarily of fibrinogen. Commercial fibrin glues are created from pooled homologous human donors; Tissel (Baxter) and Hemaseal are examples of commercially available fibrin sealants. Autologous fibrin sealants can be created from platelet-poor plasma. This policy does not address the use of fibrin sealants.
Note: This policy only addresses the use of blood-derived growth factors, including platelet-rich plasma, as a primary treatment of wounds or other conditions, including but not limited to treatment of lateral epicondylitis (i.e., tennis elbow), plantar fascitis, or Dupuytren’s contracture. This policy does not address the use of blood-derived growth factors as an adjunct to surgery, including but not limited to their use in periodontal, plastic/reconstructive, or orthopedic procedures.