The new
collagen way

The most innovative
and advanced method
of treating chondropathies

Hydrolyzed collagen low molecular weight peptides for intra-articular
CHondroGrid® Kit

A new approach and a new therapeutic opportunity

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.

CE 0373

Kit code CHG-PK4
Italian Ministry of Health Registration Code 11693

Distributore esclusivo Italia

CHondroGrid® Kit

CHondroGrid® - Hydrolyzed collagen
CHondroGrid®
Package contents

Package contents

  • 1 Sterile lyophilized ChondroGrid®
    4 mg bottle
Kit accessories and Instructions for use
CHondroGrid® Accessories
Applicative protocols

Package contents

  • 1 Sterile injectable water 2 ml vial
  • 1 Sterile 5 ml luer-lock syringe
  • 2 Sterile 5 cm, 21 Gauge needles

Applicative Protocolos

  • INTRA-ARTICULAR INJECTION
  • POSOLOGY: 3 injections
  • 2 injections performed at 15 days apart and the third one month after the last injection

Hydrolyzed collagen

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 suffering 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.

Scientific 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.

Collagen Collagen
Gelatin Gelatin
Peptides Collagen peptides
lower than 3 kDa
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, 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.

Indications

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, and for cleaning and/or reconstructing the articular cartilage.

Safety and performance

TSE-related Safety

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.

Microbiological Safety

Bioteck 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.

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

Effectiveness

Hydrolyzed collagen is absolutely non cytotoxic. Instead, in vitro experiments show it increases all parameters measuring cell vitality (1),(4). No immunogenic e􀎍ects 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), (6), (7), (8). Such studies include double-blind randomized clinical trials on patients a􀎍ected by knee osteoarthrosis (9), (10).


Scientific references

1. Oesser, S. & Seifert, J. Stimulation of type II collagen biosynthesis and secretion in bovine chondrocytes cultured with degraded collagen. Cell Tissue Res. 311, 393–399 (2003).
2. Furuzawa-Carballeda, J., Muñoz-Chablé, O. A., Barrios-Payán, J. & Hernández-Pando, R. Effect of polymerized-type I collagen in knee osteoarthritis. I. In vitro study. Eur. J. Clin. Invest. 39, 591–597 (2009).
3. Nakatani, S., Mano, H., Sampei, C., Shimizu, J. & Wada, M. Chondroprotective effect of the bioactive peptide prolyl-hydroxyproline in mouse articular cartilage in vitro and in vivo. Osteoarthr. Cartil. OARS Osteoarthr. Res. Soc. 17, 1620–1627 (2009).
4. Ohara, H., Iida, H., Ito, K., Takeuchi, Y. & Nomura, Y. Effects of Pro-Hyp, a collagen hydrolysate-derived peptide, on hyaluronic acid synthesis using in vitro cultured synovium cells and oral ingestion of collagen hydrolysates in a guinea pig model of osteoarthritis. Biosci. Biotechnol. Biochem. 74, 2096–2099 (2010).
5. Cooperman, L. & Michaeli, D. The immunogenicity of injectable collagen. I. A 1-year prospective study. J. Am. Acad. Dermatol. 10, 638–646 (1984).
6. DeLustro, F. et al. Reaction to injectable collagen: results in animal models and clinical use. Plast. Reconstr. Surg. 79, 581–594 (1987).
7. Furuzawa-Carballeda, J., Muñoz-Chablé, O. A., Macías-Hernández, S. I. & Agualimpia-Janning, A. Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study. Eur. J. Clin. Invest. 39, 598–606 (2009).
8. Hiroki Ohara, Hiroyuki Iida, Kyoko Ito, yasuo Takeuch and Yoshihiro Nomura . Effect of Pro-Hyp, a Collagen-Hydrolysate-Derived Peptide on Hyaluronic Acid Synthesys, Using in Vitro Coltured Synovium Cells and Oral Ingestion of Collagen Hydrolysated in a Guinea Pig Model of Osteoarthritis. Biosci.Biotechnol. Biochem., 74(10) , 2096-2099, 2010
9. Furuzawa-Carballeda, J. et al. Polymerized-type I collagen downregulates inflammation and improves clinical outcomes in patients with symptomatic knee osteoarthritis following arthroscopic lavage: a randomized, double-blind, and placebo-controlled clinical trial. ScientificWorldJournal 2012, 342854 (2012).
10. Kumar S, Sugihara F, Suzuki K, Inoue N, Venkateswarathirukumara S. A double-blind, placabo-controlled, randomised, clinical study on the effectiveness of collagen peptide on osteoarthritis. J Sci Food Agric.. 2015 Mar. 15;95(4):702-7. dol: 10.1001Jsfa.6752. Epub 2014 Jun 24