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Hydrolyzed kollagen

CHondroGrid® is a locally-acting medical device that makes hydrolyzed collagen low-molecular weight peptides immediately available at the site of interest, and allows effective treatment of pain and loss of functionality caused by articular affections.

Collagen is the main component of all intra-articular structures. Therefore, when joints are injected with hydrolyzed collagen, a mixture of low-molecular weight peptides, these small molecules actively prompt the reparation and reinforcement of the articular matrix and they also help the recovery and preservation of the native trophic state of all the joint compartment.

CHondroGrid® consists of 4 mg of lyophilized peptides with a molecular weight lower than 3kDa. After being suspended in injectable water, and consequently delivered to the patient by intra-articular injection, they spread rapidly all over the articular surface.

CHondroGrid® targets directly the suering site, delivering small collagen-specific amino acid chains that will support the structural and functional recovery of the intra-articular components. As a consequence, articular pain and function improve. CHondroGrid®, therefore, may help reducing analgesics and NSAIDs. Scientic investigations have shown that low molecular collagen peptides are a natural byproduct of physiologic or pathologic collagen degradation. When present, these small molecules are ready to be incorporated again into newly-generated collagen chains.

CHONDROGRID® IS THE INNOVATIVE SOLUTION TO TREAT PAINFUL, DYSFUNCTIONAL AND DEGENERATIVE ARTICULAR DISORDERS.

Extracellular matrix reinforcement
New collagen synthesis
Inflammation reduction
Pain relief

Action

Cartilage and the surrounding articular structures (the ligaments and the synovial membrane) consist primarily of collagen fibers. After the intra-articular injection, the numerous low-molecular weight peptide chains CHondroGrid® consists of, diffuse into the synovial liquid and spread over the synovia and the articular cartilage, reinforcing and repairing its damaged or worn extracellular matrix. The joint recovers its function, and pain symptoms are alleviated.

Indication

The most common indications for the use of CHondroGrid® are the symptoms, management and functional treatment of: osteoarthritis, acute or chronic arthrosynovitis secondary to osteoarthritis or rheumatoid arthritis, traumas or injuries, articular overload and overwork.

CHondroGrid® is also indicated in cases of degenerative meniscopathies, prior to and following meniscectomy surgery, or cleaning and/or reconstructing the articular cartilage.

Safety and performance

Hydrolyzed collagen is absolutely non cytotoxic. Instead, in vitro experiments show it increases all parameters measuring cell vitality (1), (4). No immunogenic effects have ever been observed in vivo (5). It has been shown to be effective on degenerative articular disorders both in pre-clinical and clinical studies published in international, peer-reviewed journals (3), (4), (6), (7). Such studies include double-blind randomized clinical trials on patients affected by knee osteoarthrosis (8), (9).

CHondroGrid® is manufactured starting from pharma-grade highly purified bovine collagen. The extraction process applied to purify the CHondroGrid® bovine collagen has been certified safe by the European Directorate for the Quality of Medicines (EDQM) as far as the TSE (Transmissible Spongiform Encephalopathies) risk is concerned. During its production, Bioteck further checks the raw material for the absence of prions using biomolecular assays, such as Western Blot Test and HPLC chromatography. Safety and performance assessments performed on the CHondroGrid® device have been validated by all the Member States of the European Community.

Manufacturer performs strict microbiological tests on each product batch and monitors, along the entire production line, all the environments where the device is manufactured and packaged. After packaging, the product is sterilized by beta irradiation at a 25 kGy dose. The irradiation preserves all the qualitative and quantitative features of the peptide profile, causing no decay of the device performance. HPLC data recorded before and after sterilization show that the chromatographic peaks fully overlap, as shown in the plot that follows.

The CHondroGrid® 214 nm chromatograms before (blue) and after (red) 25 kGy beta ray-sterillization, showing complete overlapping.

APPLICATION PROCEDURE

  1. Open the ampoule of sterile water for injections.
  2. Draw 2 ml of sterile water for injections into a 5 ml syringe.
  3. Remove the CHondroGrid vial and inject sterile water through the rubber cap.
  4. Mix the contents of the vial until completely dissolved.
  5. Then tilt the vial to draw the entire contents into the syr.

3 intra-articular injections are given over 45 days: First: Day 1, Second: Day 15, Third: Day 45.

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