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Peptys

MATRIX REINFORCEMENT

Peptys

PEPTYS is a class III EC certified medical device, based on a solution of hydrolyzed collagen-derived low molecular weight peptides (LWPs), in pre-filled syringe for the direct reinforcement and the renewal of the extra-cellular matrix of all connective tissues.

Once locally injected into the area to be treated, LWPs stimulate the connective tissue, supporting its structural and functional recovery.

The action of these small amino acid sequences is further enhanced by the special formulation of PEPTYS which contains vitamin C in the form chemically stabilized by the addition of magnesium

Main features and benefits

Collagen struCture

Collagen accounts for over 30% of the total protein content in humans and it constitutes the fundamental structural element of connective tissues such as bone, cartilage, ligaments and tendons.

It consists of three long amino acid chains, composed each of about 800 amino acids, wrapped in a compact triple helix.

Its structural unit, named tropocollagen, has a molecular weight slightly below 300 kDa and it contributes with copies of itself to the formation of collagen fibers, protein structures with a weight of tens of millions Dalton.

WE ALREADY USES LOW MOLECULAR WEIGHT PEPTIDES (LWPs) NATURALLY

During the physiological process of tissue renewal, collagen degrades and frees amino acid sequences of various molecular weights, called peptides.

The shorter peptide chains (with lower molecular weight) are the first to be used by our body to counteract matrix degradation, limiting lytic enzyme activity and stimulating new collagen synthesis.

For several years, researchers and doctors have understood the role of these peptides in the trophism of connective tissue and, in particular, of the cartilage. Many studies have shown that LWPs can significantly improve symptoms and functionality of joints and peri-articular structures, protecting their tissue matrix from excessive degradation, reinforcing and stimulating its renewal.

THE PRODUCTION OF THE COLLAGEN HYDROLYSATE

Through a specific hydrolytic degradation process, the very long collagen chain is cut into shorter amino acid sequences, then filtered to collect those with a molecular weight of about 3 kDa. This mixture of LWPs is able to actively stimulate the repair and reinforcement of the extra-cellular matrix (ECM) and to help the recovery and conservation of the trophic state of native tissues.

kollagen

ORIGIN OF THE RAW MATERIAL

The collagen used for the preparation of the LWPs, is extracted from bovine skins and tendons. It is therefore mainly collagen Type I. This is quite irrelevant because PEPTYS does not contain collagen, but LWPs.

Many scientific studies on chondrocyte cultures have shown that even enriching the colture-medium with cartilage-specific collagen  type II , there is no increase in the synthesis of collagen type II or proteoglycans, which is instead observed when adding these LWPs.

This happens because the mechanism of action does not reside in the type of collagen used to obtain the LWPs, but only in their size and structure. LWPs are bioactive due to their low molecular weight which allows a high biological interaction with the cellular components of our connective tissue.

PRODUCT SAFETY

The safety of PEPTYS is at the highest level. Raw materials comply with all the EU Directives. The applied process of collagen degradation is validated as effective against TSE and the supplier is EDQM and HACCP certified.

In addition, the manufacturer Tiss’You  provides in its Quality Control activities, the execution of mass spectrometry on each batch of peptides. This analysis allows to check the maximum size of the elements contained in each batch, which must be about 3 kDa.

The protein structures of prions are about 10 times larger than it and therefore the conformity of the product also determines the guarantee of safety with regard to TSE.

PEPTYS is finally  gamma rays sterilized at 25 kGy.

Innovative formula

Its special and innovative formulation together with high concentration of LWPs, also includes chemically stable vitamin C and magnesium to protect the peptide structure during the sterilization process of the device.

Vitamica C
Foundamental co-factor for collagen biosynthesis, it also exerts strong antioxidant action
Magnesium

Promotes cell adhesion and cartilage formation

PEPTYS is indicated for the direct reinforcement of the extra-cellular matrix of connective tissue, naturally rich in collagen. Its formulation is also recommended for the improvement of articular mobility and for the management of pain symptoms of joints and surrounding connective structures (muscles, tendons, ligaments, menisci) caused by aging, degeneration, trauma, overload and postural defects. It is also indicated after joint surgery (meniscectomy, ligament reconstruction, articular cartilage repair) to accelerate the functional recovery and to improve post-operative comfort.

PEPTYS Regain in its particular 10 ml formulation is instead dedicated to joint washing after arthroscopic procedures.

Peptys 2

Intra-articular injection

Firmly connect the PEPTYS 2 mg/ml  2 ml syringe (ref. PEP-22 or PEP-21 for small joints) to a 23-28G needle by turning slightly, then proceed with the injection under aseptic conditions.

Suggested treatment
Three injections: day 1, day 15 and day 45.

Intra-tendinous-ligamentous injection

Firmly connect the PEPTYS 2 mg/ml syringe 1 ml  (ref. PEP-21) to a 26- 28G needle by turning slightly, then proceed with the injection under aseptic conditions.

Suggested treatment
Three injections – day 1, day 21 and day 42.

Intra-muscular injection

Firmly connect the PEPTYS 2 mg/ml  1 ml syringe (PEP- 21) to a 26-28G needle by turning slightly, then proceed with the injection under aseptic conditions.

Suggested treatment
Two injections: day 1, day 10.

Peptys 5

Intra-articular injection

Firmly connect the PEPTYS 5 mg/ml  2 ml syringe (ref. PEP-52 or PEP-51 for small joints) to a 23-28G needle by turning slightly, then proceed with the injection under aseptic conditions

Suggested treatment
One injection.

Intra-tendinous-ligamentous injection

Firmly connect the PEPTYS 5 mg/ml syringe 1 ml (ref. PEP-51) to a 26- 28G needle by turning slightly, then proceed with the injection under aseptic conditions.

Suggested treatment
One injection.

Intra-muscular injection

Firmly connect the PEPTYS 5 mg/ml 1 ml syringe (PEP- 51) to a 26-28G needle by turning slightly, then proceed with the injection under aseptic conditions.

Suggested treatment
One injection.

Peptys Regain

Intra-articular injection following arthroscopy or joint lavage

Firmly connect the PEPTYS Regain 1 mg/ml 10 ml syringe (ref. PEP-110) to a 20-22G needle by turning slightly. Under aseptic conditions, inject into the joint through an arthroscopic portal.

Suggested treatment
One injection at the end of the arthroscopy surgery.

INTRA-ARTICULAR TREATMENT

Joint discomfort due to:

  • overload
  • fatigue
  • trauma

Osteoarthritis

After joint surgery:

  • meniscectomy
  • legament reconstruction
  • cartilage repair

PERI-ARTICULAR
TREATMENT

Enthesitis-tendinitis and tendinosis:

  • yarrow enthesitis
  • plantar fasciitis
  • epicondylitis
  • epithrocleitis
  • patellar enthesitis
  • shoulder tendinitis / tendinosis

TREATMENT GOALS

  • Reduce pain and inflammation
  • Improve mobility
  • Promote and accelerate healing after injury / surgery
  • Stimulate the reinforcement of the connective tissue matrix
  • Increases the strength of tendons and ligaments
  • Reduce the risk of injury
LWPs ACTION

LWPs ACTION

The bioactive LWPs of PEPTYS, locally injected, come into immediate contact with cellular components and connective tissue matrix, supporting its recovery, when altered or damaged due to overload, trauma, degenerative and / or inflammatory pathologies.

This direct mechanical reinforcement and the rapid stimulation to   new collagen synthesis, favors the natural restoration of tissue structure and functionality.

PEPTYS with its LWPs provides specific amino acid sequences of the collagen, useful for the structural and functional recovery of joints, tendons and muscles.
The structural reinforcement action promptly exerted by the peptides helps to quickly relieve symptoms and to recover the functionality of the connective tissues, e.g., improving joint mobility, reducing inflammation, and offering rapid and prolonged pain relief.

INFLAMMATION AND PAIN REDUCTION

Clinical studies on LWPs (per OS and via intra-articular injection) have shown very effective pain relief. The mechanism by which this rapidly happens, has not been completely clarified yet. These peptides surely represent an optimal substrate for the action of cell components involved in the regulation of homeostasis. Furthermore, the peptides naturally carry out a negative regulation of lytic enzymes leading to a significant reduction in inflammation, another element which, together with the reinforcement of the matrix, contributes to a durable pain relief.
EXTRA-CELLULAR MATRIX REINFORCEMENT

LWPs provide specific amino acid sequences of the collagen structure at the injection site, useful for the structural and functional recovery of joints and peri-articular structures.

PRO-REGENERATIVE ACTION

PEPTYS LWPs are able to stimulate an increase in the synthesis of collagen and other elements of the connective tissue matrix, turning the event from reparative to regenerative.

In-vitro studies showed that the addition of LWPs to the medium of chondrocyte cultures produced a dose depend increase in the synthesis of collagen type II till 2,5 more time compared to cultures with only inductive medium.

CARTILAGE AND CONNETTIVE TISSUE PROTECTION

LWPs protect the extra-cellular matrix of connective tissue, avoiding excessive degradation.

In vivo, LWPs and Pro-Hyp peptide specifically inhibited chondrocyte loss and thinning of the articular cartilage layer.

EXTRA-CELLULAR MATRIX REINFORCEMENT

LWPs provide specific amino acid sequences of the collagen structure at the injection site, useful for the structural and functional recovery of joints and peri-articular structures.

PRO-REGENERATIVE ACTION

PEPTYS LWPs are able to stimulate an increase in the synthesis of collagen and other elements of the connective tissue matrix, turning the event from reparative to regenerative.

In-vitro studies showed that the addition of LWPs to the medium of chondrocyte cultures produced a dose depend increase in the synthesis of collagen type II till 2,5 more time compared to cultures with only inductive medium.

CARTILAGE AND CONNETTIVE TISSUE PROTECTION

LWPs protect the extra-cellular matrix of connective tissue, avoiding excessive degradation.

In vivo, LWPs and Pro-Hyp peptide specifically inhibited chondrocyte loss and thinning of the articular cartilage layer.

JOINT MOBILITY IMPROVEMENT

Strong pain relief, reduction of inflammation, strengthening of the extra-cellular matrix of cartilage and joint structures, facilitate the recovery of the correct posture and movement dynamics, effectively contributing to a general joint mobility improvement.

Peptys

SCIENTIFIC REFERENCES

Stimulation of type II collagen biosynthesis and secretion in bovine chondrocytes cultured with degraded collagen.
Oesser S, Seifert J.
Cell Tissue Res. 2003 Mar;311(3):393-9. Epub 2003 Feb 25.

Oral administration of (14)C labeled gelatin hydrolysate leads to an accumulation of radioactivity in cartilage of mice (C57/BL).
Oesser S, Adam M, Babel W, Seifert J.
J Nutr. 1999 Oct;129(10):1891-5.

Chondroprotective effect of the bioactive peptide prolyl-hydroxyproline in mouse articular cartilage in vitro and in vivo.
Nakatani, S., Mano, H., Sampei, C., Shimizu, J. & Wada, M.
Osteoarthr. Cartil. OARS Osteoarthr. Res. Soc. 17, 1620–1627 (2009).

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.
Hiroki Ohara, Hiroyuki Iida, Kyoko Ito, yasuo Takeuch and Yoshihiro Nomura.
Biosci.Biotechnol. Biochem., 74(10) , 2096-2099, 2010

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.
Furuzawa-Carballeda, J. et al.
ScientificWorldJournal 2012, 342854 (2012).

Periodic knee injections of collagen tripeptide delay cartilage degeneration in rabbit experimental osteoarthritis
Takuya Naraoka, Yasuyuki Ishibashi, Eiichi Tsuda, Yuji Yamamoto, Tomomi Kusumi, Satoshi Toh
Arthritis Res Ther. 2013 Feb 22;15(1)

A double-blind, placabo-controlled, randomised, clinical study on the effectiveness of collagen peptide on osteoarthritis.
Kumar S, Sugihara F, Suzuki K, Inoue N, Venkateswarathirukumara S.
J Sci Food Agric.. 2015 Mar. 15;95(4):702-7. dol: 10.1001Jsfa.6752. Epub 2014 Jun 24

Intra-Articular Injection of Hydrolyzed Collagen to Treat Symptoms of Knee Osteoarthritis. A Functional In Vitro Investigation and a Pilot Retrospective Clinical Study.
Paola De Luca, Alessandra Colombini, Giulia Carimati, Michelangelo Beggio, Laura de Girolamo, Piero Volpi
Clin. Med. 2019, 8, 975

Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study.
Piero Volpi, Raul Zini, Franz Erschbaumer, Michelangelo Beggio, Alberto Busilacchi, Giulia Carimati
International Orthopaedics https://doi.org/10.1007/s00264-020-04616-8

Effects of ingestion of collagen peptide on collagen fibrils and glycosamino-glycans in Achilles tendon
Jun Minaguchi, et al.
J Nutr Sci Vitaminol (Tokyo).2005 Jun;51(3):169-74.

Collagen peptide supplementation in combination with resistance training improves body composition and increases muscle strength in elderly sarcopenic men: a randomised controlled trial.
Zdzieblik, S. Oesser, et al.
Br J Nutr. 2015 Oct 28; 114(8): 1237–1245

Specific Collagen Peptides Improve Bone Mineral Density and Bone Markers in Postmenopausal Women-A Randomized Controlled Study
König, et al.
Nutrients. 2018 Jan; 10(1): 97.

Effects of collagen-derived bioactive peptides and natural antioxidant compounds on proliferation and matrix protein synthesis by cultured normal human dermal fibroblasts.
Edgar, et al.
Scientific Reports volume 8, Article number: 10474 (2018)

Curcuminoids extract, hydrolyzed collagen and green tea extract synergically inhibit inflammatory and catabolic mediator’s synthesis by normal bovine and osteoarthritic human chondrocytes in monolayer.

Comblain F, Sanchez C, Lesponne I, Balligand M, Serisier S, Henrotin Y.
PLoS One. 2015 Mar 23;10(3):e0121654

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.
Janette Furuzawa-Carballeda et al.
ScientificWorldJournal. 2012;2012:342854.

Oral Supplementation of Specific Collagen Peptides Combined with Calf-Strengthening Exercises Enhances Function and Reduces Pain in Achilles Tendinopathy Patients.
Stephan F E Praet et al.
Nutrients. 2019 Jan 2;11(1):76.

Effect of Perioperative Vitamin C Supplementation on Postoperative Pain and the Incidence of Chronic Regional Pain Syndrome: A Systematic Review and Meta-Analysis.
Chen S et al.
Clin J Pain. 2016 Feb;32(2):179-85.

Effects of ingestion of collagen peptide on collagen fibrils and glycosamino-glycans in Achilles tendon
Jun Minaguchi, et al.
J Nutr Sci Vitaminol (Tokyo).2005 Jun;51(3):169-74.

The role of vitamin C in the treatment of pain: new insights.
Anitra C. Carr1 et al.
Carr and McCall J Transl Med (2017) 15:77

Magnesium and osteoarthritis: from a new perspective.
Stephan Yifeng Zhang1 et al.
Aoj.2016.11.04

Association between Dietary Magnesium Intake and Radiographic Knee Osteoarthritis.
Chao Zeng et al.
PLoS One. DOI:10.1371/journal.pone.0127666

Magnesium enhances adherence and cartilage formation of synovial mesenchymal stem cells through integrins.
Shimaya et al.
Osteoarthritis and Cartilage 18 (2010) 1300e1309