PRoPosit Bio Method
What is the PRoPosit Method?
PRoPosit is a method used to prepare platelet-rich plasma (PRP) that differs from other available methods.
A single blood draw can be used to obtain PRP for several applications by means of a closed system that allows storage .
The method provides highly concentrated PRP by high-efficiency centrifugation.
The entire process is logistically simple, enabling the medical professional to prescribe and apply the treatment whereas PRoPosit handles blood drawing and PRP preparation.
The procedure complies with legal regulations (including mandatory testing), uses material with the CE marking and handles transport and storage as per regulations.
PRoPosit Bio provides a report with quality control analyses on the PRP obtained and PRP labelling to ensure traceability.
PRoPosit Bio also performs mandatory pharmacovigilance work and stores samples from each blood draw (serum bank).
PRoPosit Bio also offers other blood products for local use in addition to PRP.
How is it accomplished?
Interview and informed consent
Patients referred by the medical professional undergo a medical interview and given an explanation of the blood draw procedure and preparation of PRP, after which they sign an informed consent document.
Blood draw
Blood is drawn from the patient in a citrated bag, similar to a blood donation but taking less blood (around 150 mL). This volume is 8 to 10 times more than the volume taken by other PRP methods, in which a tube is used to draw blood.
“Closed system”
A closed system is not merely a device packaged in a sterile container. For instance; a packaged syringe is sterile until the time of use. However, it does not meet the requirements of a closed system because the blood drawn comes into contact with the environment and, therefore, the blood can become contaminated.
PRoPosit’s PRP process is based on a system that prevents ambient air contact with the blood or PRP produced, over the entire time (from blood draw to PRP use). This avoids the risk of PRP bacterial contamination, ensures product sterility and allows it to be stored.
High-efficiency centrifugation
The protocol developed by PRoPosit Bio uses two-step centrifugation to obtain a very high platelet concentration in the PRP (on average, 7 times the patient’s baseline value), with platelet counts around 1100 109/L on average.
Several applications from a single blood draw
The PRoPosit-150 system can produce several PRP vials from a single blood draw. This is possible because higher blood volumes are used and because the processing system is sterile. As a result, the resulting PRP can be stored.
Required testing
The processes performed by PRoPosit Bio include mandatory testing to determine the presence of hepatitis (HBV and HCV), AIDS (HIV) and syphilis, including serology and genome tests for the first three viruses. The tests also include blood group typing and screening for irregular antibodies.
If any markers are positive for infection, then the PRP cannot be released, as per current legal regulations.
Product quality testing
The steps performed by PRoPosit include a medical report listing the results on infectious agents and an analysis of the patient’s blood (blood counts), as well as quality control of the PRP, including platelets, WBC and RBC concentrations. These tests are not mandatory but indicate the quality of the PRP to be used. The report also includes the patient’s blood group and the irregular antibody screening results.
Serum bank
PRoPosit keeps frozen samples of the products obtained for at least one year to determine levels of growth factors, or any other test that might need to be performed or repeated.
Labelling
The products prepared by PRoPosit are labelled as set out in Appendix 11 of Spanish Royal Decree 1088/2005. These data include the patient’s name, national ID number, Rh-blood group and irregular antibody screening for the patient-donor, donation-bracelet number, product name, volume, concentration and total content (in platelet products), volume of the anticoagulant used, draw date, product expiry and storage conditions.
Transport and storage
PRP is transported and stored according to legal regulations applicable to blood products (Spanish Royal Decree 1088/2005), both with regard to the containers used and the temperature logs that ensure proper storage of the products prepared.
PRoPosit keeps continuous temperature logs for products stored at the PRoPosit facilities and at the facilities of prescribing professionals who store their patients’ products.
PRoPosit also transports products under controlled conditions, with continuous temperature logging, similar to the procedures used to store and transport blood products.
Factor release (activation)
Growth factors inside platelets can be released by chemical (calcium, ADP, thrombin, etc.) or physical methods, such as freezing-thawing. Chemical methods have the limitation of only acting selectively on some platelet granules, whereby at PRoPosit we prefer freezing-thawing because it releases all the factors, as it ruptures the platelet’s cell structure and allows growth factors to be preserved during storage.
Gelation
PRP gelation to form a membrane is a process that allows PRP to be applied to ulcers, wounds or surgical beds.
Other products
The PRoPosit method can be used to obtain other therapeutic products from the same blood draw. After the PRP is prepared, platelet-poor plasma (PPP) can also be obtained and used as a haemostatic gel or can be processed to obtain a cryoprecipitate, a fraction that concentrates all the contents into fibrinogen, factor VIII and von Willebrand factor. These products can then be used along with PRP to obtain products with combined characteristics, such as fibrin glue, platelet glue, etc.
The plasma fraction is obtained by initially separating it from the red-cell fraction, which is usually discarded. However, it may be used if needed for some therapeutic purpose.
Logistics
Patients seen by PRoPosit Bio are referred by a physician, podiatrist or dentist who prescribes PRP. These professionals determine the indicated use of PRP, notify patients of the possible benefits and risks of the procedure and apply the PRP prepared by PRoPosit.
Patients referred to PRoPosit receive information on the characteristics of the procedure used to prepare the PRP. The patient signs an informed consent document, and the interview process begins.
Patients are interviewed and asked about their prior or current illnesses and about their current medications. This interview aims to identify any risks for the patient when blood is taken and also to evaluate any aspects that could affect the efficacy of the PRP to be prepared, e.g., certain medications. After the interview, the patient’s blood pressure and pulse are taken.
PRoPosit uses a transfusional safety system based on numerically coded wristbands to ensure product traceability from draw to use, thus reducing the risk of using the product in the wrong patient.
If the patient’s examination is satisfactory, then PRoPosit collects and processes blood to obtain the various PRP units.
Once the PRP products are ready, they are sent for storage at PRoPosit’s own facilities or at the prescribing physician’s site. To ensure adequate product storage and transport, PRoPosit is responsible for maintaining the equipment using a temperature control system similar to those used in blood banks.
Pharmacovigilance
According to the new regulations of the Spanish Medicines Agency (AGEMED), all suspected adverse reactions occurring in PRP-treated patients must be reported to the relevant health authorities.
PRoPosit provides medical professionals who use our procedure with a tool for follow-up of treated patients by periodic phone calls during the first year after PRP application, as a system to identify adverse reactions in patients. If any are detected, then the prescribing professional is notified of the treatment so that they re-evaluate the patient and notify the health authorities of the event, if deemed necessary.
CE Marking
All material used during blood extraction, processing and storage of the products obtained bears the CE marking for blood product collection and processing.
El plasma Rico en plaquetas (PRP) es un componente sanguíneo preparado a partir de la sangre de un donante o un paciente.
PRoPosit Bio is a SME that was founded with the goal of carrying out research and Innovating in the Areas of Transfusion, Hemotherapy and Cell Therapy
