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What is Cellular Matrix® ?

Cellular Matrix® tubes allow the preparation of autologous platelet-rich plasma (RegenPRP®) combined with a non-crosslinked hyaluronic acid (HA) in a closed-circuit system.

CM-PRP-HA has an excellent safety profile in clinical practice.1,3,4

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Cellular Matrix® technology combines the complementary clinical effects of RegenPRP® and hyaluronic acid (HA), giving better and longer-lasting results in patients with osteoarthritis.1,3,4

Hyaluronic Acid

Hyaluronic acid is a major component of synovial fluid contributing to joint homeostasis.

  • 25 years of clinical experience shows pain relief and functional improvement lasting 6 to 12 months in OA patients.
  • Plays a major role in viscosupplementation and pain relief in OA.5
  • The network of HA chains generates an ideal cell-friendly matrix when combined with PRP.6

Hyaluronic acid improves the activity of several molecules contained in platelet-rich plasma to provide additional benefits to OA patients1.

Both PRP and HA have been extensively used to improve lubrication, modulate inflammation and modify the joint catabolic micro-environment, aiming not only to reduce clinical symptoms, but also to slow down OA progression2.

When PRP and HA are used in combination these effects are enhanced and prolonged. HA creates a bioactive scaffolding in which the platelets progressively release their growth factors. RegenPRP does not negatively affect the mechanical, elastic or viscous properties of HA1.

Technology platform for standardized autologous regenerative medicine

The simple, safe and efficient point-of-care preparation of autologous platelet-rich plasma.

TECHNOLOGY ADVANTAGES

  • User-independent standardized preparation
  • Minimum volume of blood required
  • Safe closed-circuit system
  • Mechanical isolation of PRP using a biologically inert gel after a 5-minute centrifugation
  • Reversible anticoagulation with a pharmaceutical grade solution of sodium citrate at pH 7
  • Minimal learning curve and ease of use
  • Operationally and clinically efficient process
  • Facilitates and streamlines routine practice

CELLULAR MATRIX PLATFORM

  • Certified technology for the preparation of RegenPRP® combined with hyaluronic acid (HA) (CM-PRP-HA)
  • Contains 2 ml of non-crosslinked HA at a concentration of 20 mg/ml (40 mg total)
  • HA produced by bacterial fermentation, thus free of animal proteins
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SCIENTIFIC ADVANTAGES OF RegenPRP®

  • Demonstrated safety and efficacy
  • Evidence-based outcomes for numerous therapeutic indications
  • Large number of clinical studies, with over 200 publications

Biological advantages

  • RegenPRP® is standardized, leucocyte reduced and easily reproducible
    Regen Lab specific separating gel technology guarantees minimal variability
  • Platelets recovery in CM-PRP-HA >70%
  • High platelet quality
    Viable & functional platelets
  • Full plasma recovery
    No loss of plasma growth factors and fibrinogen
  • Leucocyte reduced PRP Depletion ~ 94.3% of pro-inflammatory granulocytes, leaving mainly lymphocytes and monocytes
  • Virtually no red blood cells
    Depletion of ~ 99.5% of erythrocytes

RegenPRP standardized performance

A-CP-HA Tube Properties

 

benefit
BLOOD SAMPLE VOL PER TUBE

6 ml

benefit
PRP VOL PER TUBE

~3 ml of PRP combined with 2 ml of HA

benefit
PLATELET RECOVERY

> 70 %

benefit
GRANULOCYTE DEPLETION

94.3 %

benefit
RED BLOOD CELL DEPLETION

99.5 %

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Clinical evidence

Intended use of the device

Device used to prepare intra-articular injections into the knee for symptomatic treatment of articular pain and mobility improvement.

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Cellular Matrix / A-CP-HA-3

Ref: A-CP-HA-3
3 A-CP-HA tubes

Contraindications

Absolute contraindications:

Do not administer the PRP/HA preparation to patients with ascertained hypersensitivity to one of the components, including hyaluronic acid. Do not use on patients with hereditary or acquired hematologic /coagulation disorders such as platelet dysfunction syndrome, critical thrombocytopenia, impaired coagulation or patients suffering from uncontrolled severe metabolic or systemic disorders. Do not treat patients who present septicemia or acute infection in the area of the treatment. It is recommended not to use the PRP/HA preparation in patients with partial or total knee prosthesis.

Relative contraindications:

It is recommended not to use the PRP/HA preparation in patients with malignancy, particularly with hematologic or bone involvement and metastatic disease, in the previous 5 years, with autoimmune diseases with presence of antibodies and progressive (Hashimoto, rheumatoid arthritis, lupus, etc), with recent fever or illness and with platelet count less than 100’000’000/ml. Taking medication or dietary supplement which alter platelet function, within 3 days, may affect the effectiveness of the treatment. The safety and effectiveness have not been evaluated in children and in pregnant or lactating women. It is recommended not to use the PRP-HA preparation with patients with local dermatologic diseases at the site of injection.

Possible side effects

Possible side effects of blood collection:

Blood collection may cause damage of blood vessels, hematomas, superficial phlebitis, delayed wound healing and / or infections, temporary or permanent nerve damage that may result in pain or numbness and early or late infections.

Possible side effects of intra-articular injections:

When injected intra-articularly, 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 or area treated with the PRP/HA preparation. Icepacks application in the minutes following the injection, or oral analgesic treatment (acetaminophen) the day following the injection may decrease these inconveniences. 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.

Patented by Regen Lab SA
Cellular Matrix (PRP+HA)

U.S. patent US8945537,
U.S. patent US9517255,
European patent EP2544697B1
Canadian patent CA2789533C,
Chinese patent CN103079577B,
Australian patent AU2011225828B,
Japanese patent JP6076091,
Russian patent RU2614722,
Israeli patent IL221133

All our Patent

Bibliography

  1. Abate M. et al. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol 2015 Dec;25(8):1321-6.
  2. Seleem, N.A., et al., Intra-Articular Injections of Platelet-Rich Plasma Combined with Hyaluronic Acid Versus Hyaluronic Acid Alone in Treatment of Knee Osteoarthritis. ejpmr, 2017;4(4):608-15
  3. Renevier, J. L., et al. «Cellular matrix™ PRP-HA”: A new treatment option with platelet-rich plasma and hyaluronic acid for patients with osteoarthritis having had an unsatisfactory clinical response to hyaluronic acid alone: Results of a pilot, multicenter French study with long-term follow-up.» Int. J. Clin. Rheumatol. 2018;13(4):230-8
  4. Barac, B., et al. (The new treatment approach in knee osteoarthritis: Efficacy of cellular matrix combination of platelet rich plasma with hyaluronic acid versus two different types of hyaluronic acid (HA). Int. J. Clin. Rheumatol. 2018;13(5):289-95
  5. Huskisson, E. C., and S. Donnelly. «Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee.» [In eng]. Rheumatology (Oxford) 38, no. 7 (Jul 1999): 602-7.
  6. Smith J.D. et al. Improved growth factor directed vascularisation into fibrin constructs through inclusion of additional extracellular molecules. Microvasc Res.
    2007;73(2):84-94.

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