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Viscoll®Collagen for repairing soft tissue defects

The status of a medical product
Clinical trials of the medical device are underway

Medical product description

The product is a translucent, colorless collagen hydrogel in injectable form made of highly purified type I collagen isolated from porcine tendons. The product is intended to replace soft tissue defects. The product can be used for treatment of scars on the face and body (atrophic, post-traumatic, post-surgical, post-acne, and stretch marks), as well as for skin recovery after laser resurfacing, chemical peelings, insolation, plastic surgery, and preparation for them.

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Mechanism of action

The introduction of the product into the defected zone allows it to fill all the necessary space and take on the mechanical loads in the affected area. After implantation into the soft tissues, 4% collagen hydrogel, obtained by mixing collagen with an additional component, quickly forms a dense structure that can hold its shape and resist the force of compression of the surrounding tissue. After implantation, cells from the surrounding tissues, such as fibroblasts, penetrate the implant after injection as early as day 3. Once the cells have populated the implant, they begin to recycle it, replacing it with their own extracellular matrix. Thus, their own normal functioning tissue is formed, and the implant is resorbed. Complete biodegradation of the product takes up to 2-3 months.

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The key characteristics of a medical device

Biocompatibility, low immunogenicity and non-toxicity.

Viscoll® collagen extracted from healthy animal tissues is used to manufacture the Product. Obtaining the extract as a true solution (not a suspension) of native (not denatured) protein provides complete biochemical purification of collagen from potentially immunogenic impurities, which is controlled by appropriate immunological testing. Viscoll® collagen are sterile, apirogenic, completely bioresorbable, and irritation-free at implantation, neither in the short nor in the long term.

Thermosensitive hydrogel

The time for hydrogel formation at +37°С and in a neutral pH range is 3-5 minutes.

Adapted for the cell transplantation

The product can be mixed with the cell suspension. Cells inside the collagen hydrogel retain their viability for a long time.

Adapted for 3D bioprinting

Can be used as a bioink for 3D bioprinting.

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In vivo safety and efficacy studies of the medical device involving laboratory animals

Publications in peer-reviewed scientific journals

Authors
Levin AA, Karalkin PA, Koudan EV, Senatov FS, Parfenov VA, Lvov VA, Petrov SV, Pereira F, Kovalev AV, Osidak EO, Domogatsky SP, Manturova NE, Kasyanov VA, Sergeeva NS, Zorin VL, Khesuani YD, Mironov VA
Title
In Situ Articulated Collaborative Commercial 3D Bioprinter for Skin Wound Healing
Year
2023
Journal
International Journal of Bioprininting
DOI/URL
Authors
Isaeva EV, Beketov EE, Demyashkin GA, Yakovleva ND, Arguchinskaya NV, Kisel AA, Lagoda TS, Malakhov EP, Smirnova AN, Petriev VM, Eremin PS, Osidak EO, Domogatsky SP, Ivanov SA, Shegay PV, Kaprin AD
Title
Cartilage formation in vivo using high concentration collagen-based bioink with MSC and deecllularized ECM granules
Year
2022
Journal
International Journal of Molecular Sciences
DOI/URL
Authors
Osidak EO, Kalabusheva EP, Alpeeva EV, Belousov SI, Krasheninnikov SV, Grigoriev TE, Domogatsky SP, Vorotelyak EA, Chermnykh ES
Title
Concentrated collagen hydrogels: A new approach for developing artificial tissues
Year
2021
Journal
Materialia
DOI/URL
Authors
Beketov EE, Isaeva EV, Yakovleva ND, Demyashkin GA, Arguchinskaya NV, Kisel AA, Lagoda TS, Malakhov EP, Kharlov VI, Osidak EO, Domogatsky SP, Ivanov SA, Shegay PV, Kaprin AD
Title
Bioprinting of cartilage with bioink based on high-concentration collagen and chondrocytes
Year
2021
Journal
International Journal of Molecular Sciences
DOI/URL
Authors
Vasilyev AV, Kuznetsova VS, Bukharova TB, Osidak EO, Grigoriev TE, Zagoskin YD, Nedorubova IA, Domogatsky SP, Babichenko II, Zorina OA, Kutsev SI, Chvalun SN, Kulakov AA, Losev FF, Goldshtein DV
Title
Osteoinductive moldable and curable bone substitutes based on collagen, bmp-2 and highly porous polylactide granules, or a mix of HAP/b-TCP
Year
2021
Journal
Polymers
DOI/URL
Authors
Osidak EO, Karalkin PA, Osidak MS, Parfenov VA, Sivogrivov DE, Pereira F, Gryadunova AA, Koudan EV, Khesuani YD, Kasyanov VA, Belousov SI, Krasheninnikovv SV, Grigoriev TE, Chvalun SN, Bulanova EA, Mironov VA, Dpmogatsky SP
Title
Viscoll collagen solution as a novel bioink for direct 3D bioprinting
Year
2019
Journal
Journal of Materials Science: Materials in Medicine
DOI/URL