Cellular Matrix^®

Contraindications

Absolute contraindications:

• Platelet dysfunction syndrome
• Critical thrombocytopenia
• Hemodynamic instability
• Severe metabolic or systemic disorders
• Septicemia
• Acute/local infection at the site of the procedure
• Patient unwilling to accept risks
• Hypersensitivity to one of the components (including HA)

Relative contraindications:

• Consistent use of NSAIDs within 48 hours before the procedure
• Consistent use of other medication(s) or dietary supplement(s) which alter platelet function, within 3 days before the procedure
• Corticosteroid injection at the treatment site within 1 month before the procedure
• Systemic use of corticosteroids within 2 weeks before the procedure
• Tobacco use
• Recent fever or illness
• Malignant diseases, especially those affecting blood, bone marrow or bones, and cancers in metastatic phase
  
• Autoimmune diseases with presence of antibodies and progressive (Hashimoto, rheumatoid arthritis, lupus, etc.)
  
• Impaired coagulation
  
• Hemoglobin count < 10 g/dl
  
• Platelet count < 10⁵/ µl

Possible side effects

Possible side effects of blood collection:

Blood collection may cause damage to the blood vessels, hematomas, superficial phlebitis, early or late infection and/or temporary or permanent nerve damage that may result in pain or numbness.

Possible side effects of intra-articular injections

Following intra-articular injections, local secondary inflammatory reactions may occur at the site of injection. This may result in temporary pain, feeling of heat, redness and swelling in the joint area treated with the PRP/HA preparation. Use of ice packs in the minutes following the injection, or oral analgesic treatment (acetaminophen) the day following the injection may reduce these effects. The intake of non-steroidal anti-inflammatory drugs (NSAID) must be avoided. Following injection with HA, there have also been occasional reports of hyper-sensitivity, including, rarely, anaphylaxis. The administration of HA was also reported to provoke pronounced inflammatory reactions. Injection may lead to infection if general precautions for injection and asepsis are not respected. NB: In case any serious incident occurs in relation to the device, the user and/or patient should report this incident to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Precautions

Intra-articular injection precautions

Injections of the PRP/HA combination into the joint cavity must be performed with the same precautions as any other intra-articular injection, and preferably using ultrasound guidance. Joint effusion, if present, should be removed before injecting the PRP/HA combination. The physician must evaluate the physical aspect of the collected fluid. If any doubt, appropriate measures should be undertaken, and the physician must assess whether the intra-articular injection of PRP/HA should be performed or not. Following intra-articular injection, the patient must rest for 1h after the injection (no physical activity) and avoid prolonged (no more than 10 minutes) standing or walking for the first 12 hours after the intra-articular injection.

General precautions

The patient must be informed about the general risks associated with the treatment and the possible adverse effects. Before use, the physician must consider the patient’s medical history, especially in terms of coagulation disorders, and in case of doubt blood platelet count must be performed. When a definitive diagnosis cannot be established, and the conditions listed as contraindicated cannot be confidently excluded, the physician must perform an appropriate benefit to risk assessment for the patient prior to using the device. Strict aseptic technique must be followed during phlebotomy and injection. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Disinfectants containing quaternary ammonium salts should not be used to prepare the skin for injection because hyaluronan can precipitate in their presence. The PRP/ HA combination must be prepared from fresh blood and must be used within four hours (extemporaneous use only) by a qualified physician. Use proper safety precautions to protect against needles or broken tubes. Do not re-cap the needle after use and discard directly in the biological hazard container. Do not use the sterile components of this kit if the blister pack is opened or damaged. Do not use the components of this kit if they are broken or have a defect. Do not use the tube if it has lost vacuum. Do not use the sodium citrate solution or other tube components separately. Store between 5 °C and 30 °C; bring the kit to ambient temperature before using the tubes. Each Cellular Matrix A-CP-HA tube is for single use only; do not reuse. Reuse may lead to infection or other illness / injury. Do not re-sterilize, do not use after the expiration date. To respect the closed-circuit procedure, the user should use the accessories for phlebotomy and PRP/ HA combination collection (provided separately in the Accessory Set). Tubes must not be opened. Standard needles with coring tips should not be used to pierce the tube stopper.

All tubes are to be discarded using the appropriate disposal method for potentially contaminated blood products. Do not inject the PRP/HA combination intravascularly or for any application other than those described in the intended use. Follow the manufacturer’s instructions when using the centrifuge. Use a fixed 45° angle head centrifuge (e.g., RegenPRP Centri provided by Regen Lab). As an alternative, a horizontal head (swinging bucket) centrifuge can be used. However, this would result in a small increase in red and white blood cell contamination in the resulting PRP/HA combination. Tubes should be centrifuged, as recommended in the instructions for use, at a relative centrifugal force (RCF) of 1500 g. Excessive RCF (over 2200 g) may lead to tube breakage resulting in blood exposure, and possible injury. RCF below 1500 g may lead to incorrect blood separation and red blood cell contamination of the PRP/HA combination. Centrifuge carriers and insert size should be adapted to the tubes. Use of carriers too large or too short may result in breakage of the tubes. Caution should be taken to ensure that tubes are properly seated in the centrifuge carriers. Tubes must be balanced in the centrifuge.