Platelet rich plasma/ Platelet concentrates As licensed

Platelet Rich Plasma (PRP) / Platelet Concentrates (PC) – As Licensed


Description

  • Autologous Blood Product: PRP/PC is a blood product prepared from a patient’s own blood. It is concentrated to contain a higher number of platelets than whole blood.
  • Composition: It consists of concentrated platelets suspended in a small volume of plasma. This concentrate is rich in various growth factors and cytokines, which are the primary therapeutic components.
  • Preparation Process: The product is created by drawing a patient’s blood and processing it using a centrifuge. This process separates the blood components by density, isolating the platelets and plasma from red and white blood cells.
  • Concentration: While there is no universal standard, PRP is defined by having a platelet concentration that is at least 2 to 6 times higher than the patient’s baseline platelet count, with some preparations achieving even higher concentrations.

Advantages

  • Autologous Nature: Since PRP is derived from the patient’s own body, it significantly reduces the risk of allergic reactions, immune rejection, or the transmission of blood-borne diseases.
  • Contains Healing Factors: The high concentration of platelets releases numerous growth factors (e.g., PDGF, TGF-β, VEGF) and cytokines that are essential for stimulating tissue repair, cell proliferation, and angiogenesis.
  • Versatile Application: It is a versatile product used in various medical fields, from orthopedics and sports medicine to dermatology and dentistry, to promote healing and tissue regeneration.
  • Minimally Invasive: The preparation and application process is minimally invasive, typically involving a simple blood draw and an injection, making it an accessible point-of-care treatment option.

Uses

  • Orthopedic and Sports Medicine: Licensed for use as an adjunct to enhance bone graft handling characteristics in orthopedic surgical procedures. It is also widely used for chronic tendon injuries, osteoarthritis, and other musculoskeletal conditions, though many of these uses are considered off-label.
  • Wound Healing: Licensed for the management of chronic, non-healing wounds, particularly diabetic ulcers, as it helps to stimulate the healing process and tissue regeneration.
  • Oral and Maxillofacial Surgery: Utilized in dental implant procedures, bone grafting, and other oral surgeries to improve healing, reduce pain, and promote bone regeneration.
  • Aesthetic Medicine: Although often considered off-label, it is used in dermatology and cosmetic medicine for applications such as hair loss treatment, facial rejuvenation, and scar revision.

Nature

  • Biological Agent: Unlike a traditional drug, PRP is a biological agent that harnesses the patient’s own cells to promote healing. Its effectiveness depends on the patient’s biological response and the quality of the preparation.
  • Lack of Standardization: A significant challenge with PRP is the lack of a standardized protocol for preparation. The final product can vary widely in terms of platelet concentration, presence of white blood cells, and overall volume, depending on the commercial kit and the preparation method used.
  • Mechanism of Action: When injected, the platelets become activated and release their growth factors. These factors initiate and accelerate the natural wound-healing cascade by attracting stem cells, promoting new blood vessel formation, and stimulating tissue regeneration.
  • Regulatory Status: While the devices used to prepare PRP have received FDA clearance, the product itself (PRP) is often used for indications that have not been specifically approved by the FDA. The regulatory status can vary significantly by country and specific clinical application.

Storage

  • No Long-Term Storage: PRP is an autologous, “live” biological product and cannot be stored for long periods. It must be prepared and used immediately after collection and centrifugation to ensure the platelets remain viable and functional.
  • Point-of-Care Preparation: The preparation process is designed to be performed at the point of care, directly before the procedure. Blood is drawn, processed, and the resulting PRP is used within a very short timeframe.
  • Avoid Contamination: The entire process of preparation must be done using sterile technique to prevent microbial contamination.
  • Temperature Sensitivity: The blood and final PRP product should be kept at a controlled temperature (typically room temperature) during the preparation process to maintain platelet integrity and function. Once activated, the product has a very short window of effectiveness.

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