TR202013434A2 - Hyaluronic acid-collagen encapsulated mesenchymal stem cell-platelet-rich plasma and chondrocyte-containing product-method in the treatment of osteoarthritis - Google Patents

Hyaluronic acid-collagen encapsulated mesenchymal stem cell-platelet-rich plasma and chondrocyte-containing product-method in the treatment of osteoarthritis Download PDF

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TR202013434A2
TR202013434A2 TR2020/13434A TR202013434A TR202013434A2 TR 202013434 A2 TR202013434 A2 TR 202013434A2 TR 2020/13434 A TR2020/13434 A TR 2020/13434A TR 202013434 A TR202013434 A TR 202013434A TR 202013434 A2 TR202013434 A2 TR 202013434A2
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collagen
hyaluronic acid
osteoarthritis
chondrocyte
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Atsü Sağlam Saadet (%60)
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Saadet Atsü
Saadet Atsue Saglam %60
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Abstract

Buluş, tıp ve ilaç sanayisinde, eklem osteoartrit tedavisinde kullanılabilen, yapısında hyaluronik asit - kollagen ile enkapsüle edilmiş mezenkimal kök hücreleri, trombositten zengin plazma, kondrosit ve kombinasyonunu içeren, mezenkimal kök hücrenin, trombositten zengin plazmanın, kondrositin enkapsülasyonu yolu ile ortamda daha uzun canlı kalma ve biyoaktif moleküllerin daha uzun süre ortama verilmelerini sağlayarak kondrojenik, kondroprotektif – rejeneratif ürün ve ürün üretim yöntemi ile ilgilidir.The invention, which can be used in the treatment of joint osteoarthritis in the medical and pharmaceutical industry, contains mesenchymal stem cells encapsulated with hyaluronic acid - collagen, thrombocyte rich plasma, chondrocyte and its combination, which can be used for longer survival in the environment by encapsulation of mesenchymal stem cell, platelet rich plasma, chondrocyte. and it is about chondrogenic, chondroprotective - regenerative product and product production method by providing the release of bioactive molecules to the environment for a longer time.

Description

TARIFNAME OSTEOARTRIT TEDAVISINDE HYALURONIKASIT- KOLLAGENLE ENKAPSÜLENEN MEZENKIMAL KÖK HÜCRE-TROMBOSITI'EN ZENGIN PLAZMA VE KONDROSIT IÇEREN ÜRÜN- YÖNTEM TEKNIK ALAN Bulus, tip ve ilaç sanayisinde, eklem osteoartrit tedavisinde kullanilabilen, yapisinda hyaluronik asit - kollagen ile enkapsüle edilmis mezenkimal kök hücreleri, trombositten zengin plazma, kondrosit gibi eklem kondroprotektif - rejeneratif ajanlar ve kombinasyonunu içeren ürün ve üretim yöntemi ile ilgilidir. BULUSLA ILGILI TEKNIGIN BILINEN DURUMU Osteoartrit (0A) esas olarak eklem kikirdagini etkileyen bir eklem hastaligidir. Eklem kikirdagindaki bozulma zamanla agri ve eklem hareketlerinin sinirlanmasina sebep olmaktadir. Dejeneratif bir eklem hastaligi olan osteoartrit (0A) artiküler kartilajin progresif erezyonu, fibrilasyonu ve subkondral kemigin dejenerasyonu ile karakterize inflamatuar bir durumdur. Kikirdak yapilarin tedavisi kartilaj dokularin düsük iyilesme potansiyeli ve vaskülerizasyonu olmadigi Için oldukça güçtür. Bu nedenle hücre bazli tedaviler rejeneratif tip ve dis hekimliginde son yillarda ilgi çekmekte ve popülarite kazanmaktadir. BU LUSUN AMACI Bulus; saglik sektöründe kullanilan, yapisinda hyaluronik asit - kollagen ile enkapsüle edilmis mezenkimal kök hücreleri, trombositten zengin plazma, kondrosit gibi eklem yapisi için kondroprotektif - rejeneratif ajanlar ve kombinasyonunu içeren, rejeneratif tedavide kullanilacak mezenkimal kök hücrenin, trombositten zengin plazmanin, kondrosit gibi eklem kondroprotektif - rejeneratif ajanlarinin enkapsülasyon yolu ile ortamda canli kalma ve biyoaktif moleküllerin daha uzun süre ortama verilmelerini saglayan ürün ve üretim yöntemi ile ilgilidir. Bulusun bir amaci, kartilaj ve eklem koruyucu etkilerinin olmasi sebebiyle içeriginde enkapsülasyon malzemesi olarak hyaluronik asit (HA)-kollagen karisiminin kullanilmasidir. Bu sayede ekstrasellüler matriksin ana komponentlerinden biri olan sinoviyositler, fibroblastlar ve kondrositler tarafindan sentezlenen HA' nin hücre proliferasyonunda, doku tamirinde, hücre migrasyonundaki etkilerinden yararlanilacaktir. Buna ilaveten Hyaluronik asidin ana fonksiyonlari; yara iyilesmesinde inflamasyonun etkilerini yavaslatma, hücre proliferasyonunu ve reepitelizasyonu desteklemektir. Eklem yapisinda kayganlastirici olarak önemli rolü vardir, kartilaji korur, kartilaj ve diskin avasküler kisimlarinin beslenmesinde yardimcidir. Normalde eklem içinde viskoziteyi artirarak eklem tedavisinde kullanilmakta olan hyaluronik asidin, kollagenle kombinasyonuyla hazirlanmis olan enkapsülasyon malzemeleri hazirlayarak bunlarin ekleme saglayacagi faydali etkilerinden yararlanilmaktadir. Bulusun bir diger amaci, kartilaj dejenerasyona rejeneratif etki olusturmasi için trombositten zengin plazmanin (PRP - Platelet Rich Plasma) ve bunun hyaluronik asit (HA)-k0llagen karisimi ile enkapsüalsyonunun kullanimina imkan sunmasidir. Bu sayede PRP (Platelet Rich Plasma) hücre proliferasyonuna, kondrosit farklilasmasina ve dokunun yeniden organizasyonuna (remodeling) katki saglamaktadir. Potansiyel iyilestirme etkisi vardir. Bulusun bir diger amaci, kartilaj dejenerasyona kondrojenik etki olusturmasi için kondrositin ve bunun hyaluronik asit (HA)-k0llagen karisimi ile enkapsüalsyonunun kullanimina imkan sunmasidir. Bu sayede kondrojenik aktivite ve hasarli doku rejenerasyonu artacaktir. Bulusun bir diger amaci, Mezankimal kök hücre, PRP, kondrosit ve bunlarin hyaluronik asit- kollagen enkapsülasyon malzemesi ile enkapsüle edilerek birlikte kullaniminin tek tek rejenertif ve kondroprotektif özellikleri bilinen bu maddelerin sinerjistik etkilerinin osteoartrit tedavisinde rejeneratif ve kondroprotektif tedavi yöntemi olarak kullanilabilen bir ürün olmasidir. Bulusun bir diger amaci, TME (temporamandubular eklem) dejeneratif rahatsizliklarinda ve tüm eklem osteoartritlerinde kondroprotektif özelligi olan HA-kollagen ile kapsüle edilmis kök hücre, PRP, ve sinerjik etkilerinden ayri ayri ve kombinasyonarinin enjeksiyonu ile osteoartrit tedavisinde bilinen tedavi yöntemlerine alternatif, daha kisa zaman alan ve daha kesin çözüm yolu olabilecegini gösteren bir ürün olmasidir. Bulusun bir diger amaci, kök hücre disinda primer kondrositlerinde HA-kollagen ile tek basina ya da PRP enkapsülasyonu ile osteoartrit tedavisinde alternatif bir rejeneratif tedavi yöntemi ortaya çikaran bir ürün olmasidir. Söz konusu bulus, mevcut haliyle sektörde tercih edilen bir ürün haline gelecektir. Böylelikle hem ticari basari saglanacak, hem de saglik sektörüne osteoartriti tedavisi yönünden zengin bir tedavi yöntemi sunmaktadir. Bulusta enkapsülasyon malzemesine hapsedilmis gerek kök hücre, gerek kondrosit gerekse PRP kaynakli biyoaktif moleküllerin daha uzun süre eklem bosluguna salinarak, daha uzun süreli etki saglamasi mümkün kilinmaktadir. Enkapsülayon malzemesi eklem sivisindaki maddelerin kök hücrelere ulasmasina izin vereceginden kök hücrelerin daha uzun süre ortamda kalmalari saglanmaktadir. Enkapsülasyon malzemesi ayrica eklemin viskozitesine yardimci olmakta ve ilave bir etki saglamaktadir. BU LUSUN DETAYLI AÇIKLANMASI Bulus, eklem osteoartrit tedavisinde kullanilabilen, yapisinda hyaluronik asit - kollagen ile enkapsüle edilmis eklem kondroprotektif - rejeneratif ajanlar ve kombinasyonunu içeren ürün ve üretim yöntemidir. Bulusta eklem yapisi için kondroprotektif - rejeneratif ajan; mezenkimal kök hücre, trombositten zengin plazma, kondrosit ve bunlarin kombinasyonlarida olabilmekteclir. Eklem osteoartriti tedavisinde kök hücre kullanimi ile ilgili yapilmis az sayida çalismanin sonuçlari, kök hücre enjeksiyonunun kartilaj rejenerasyonunu stimüle edebilecegini ve TIVIE' deki progresif yikimi yavaslatabilecegine isaret etmektedir. Bu bilgi kapsaminda yapilan arastirmalar sonucu bulusta örnekleme amaciyla kök hücre enkapsülasyonun da hyaluronik asit (HA)-kollagen karisimi kullanilmistir. Ayni zamanda bu bulusta birçok büyüme faktörü içeren PRP gibi sivilarin da enkapsülasyonu yapilabilmektedir. Bu bulusta kullanilan enkapsülasyon malzemesi olan hyaluronik asit (HA)-kollagen karisiminin enkapsülasyon malzemelerinden beklenen bu özelliklere ilaveten kartilaj ve eklem koruyucu etkileri gözlemlenmistir. Tüm bu faktörler birlikte degerlendirildiginde bulusta kondroprotektif hyaluronik asit-kollagen karisimi ile enkapsüle edilmis mezenkimal kök hücre, PRP ve bunlarin sinerjistik etkilerini in vitro ve in vivio tavsan örneklerinde TME osteoartrit modeli özel bir teknikle olusturulmus ve ortaya çikan ürünle rejeneratif ve bir tedavi yöntemi gelistirilmistir. Bu teknikte TME osteoartrit modeli olusturulmus olsa da vücuttaki tüm eklem yapilarinda rejeneratif ve kondroprotektif bir tedavi yöntemi olarak uygulanabilmektedir. Bulusta trombositten zengin plazma (PRP)'nin potansiyel iyilestirme etkisi nedeniyle kartilaj dejenerasyonunda da kullanimi saglanmistir. PRP hücre proliferasyonuna, kondrosit farklilasmasina ve dokunun yeniden organizasyonuna (remodeling) katki saglamaktadir. Bulusta kök hücre enkapsülasyonunun yapilmasi hücrelerin korunmasi ve hücrelerin bir arada kalarak sinerjistik etki göstermelerini, daha uzun süre ortamda kalmalarini ve hücre kaynakli biyoaktif moleküllerin daha uzun süre ortama verilmelerini saglamak amaciyla yapilmaktadir. Bulusta kullanilan enkapsülasyon malzemesi biyouyumlu olmalidir. Besin maddelerinin hücrelere ulasmasini saglamali ve istenilen sürede ortamda kalmalidir. Bulus olusturulurken HA-kollagen enkapsülasyon malzemelerin kök hücrelere olan etkisi ve primer kondrositler üzerindeki kondrojenik kapasiteleri degerlendirilmistir. Bununla birlikte. kök hücre, PRP, kondrosit tek tek veya beraber HA-kollagen ile enkapsüle edilerek bu kombinasyon kondrojenik kapasite açisindan degerlendirilmistir. Bu analizlerde; hücre morfolojisi, glikozaminoglikan sentezi, kollagen tip I ve tip II sentezi, apoptoz, nekroz, proliferasyon, sitotoksisite ve kondrosit canliligi gibi birçok parametre histolojik, histokimyasal, immünohistokimyasal, PCR, Western Blot, spekrofotometrik, Alamar Blue, Annexin V, gerçek zamanli hücre analiz sistemleri gibi güncel yöntemlerle degerlendirilmistir. Kök hücre tedavisinde ortamda etkinligin artmasi ve iylesmenin hizlandirilmasi için kök hücre ile birlikte trombositten zengin plazma PRP (Platelet Rich Plasma) kullanilmasi saglanmistir. Bulusta kök hücre yerine sadece PRP kullanilarak ta enkapsülasyon islemi gerçeklestirilebilmektedir. Bulusta kök hücre yerine kondrosit kullanilarak ta enkapsülasyon islemi gerçeklestirilebilmektedir. Böylece kök hücre disinda primer kondrositlerinde HA-kollagen ile tek basina ya da PRP enkapsülasyonu ile osteoartrit tedavisinde alternatif bir rejeneratif tedavi yöntemi olarak ortaya konmaktadir. HYALURONIK ASIT-KOLLAGEN ENKASPÜLASYON MALZEMESININ HAZIRLANMASI, KARAKTERIZASYONU HA/Kollagen enkapsülasyon malzemesi hücrelerin korunmasi ve hücrelerin bir arada kalarak sinerjistik etki göstermelerini, daha uzun süre ortamda kalmalarini ve hücre kaynakli biyoaktif moleküllerin daha uzun süre ortama verilmelerini saglamak amaciyla yapildi. HA/Kollagen enkapsülasyon malzemesi biyouyumlu olmasi, besin maddelerinin hücrelere ulasmasini saglamasi, istenilen sürede ortamda kalmasi, toksik olmamasi ve bu özelliklerine ilave olarak kartilaj ve eklem koruyucu özelliklerinden dolayi çogunlukla tercih edilen malzemeler arasinda yer almaktadir. Enkapsülasyon malzemesinin hazirlanmasinda Kollagen Tip II (Nutragen), hyaluronik asit ve çapraz baglayici ajan olarak 4 arm Polietilen Glikol Succinimidyl Glutaramide (4sPEG) (Jenkem Technology) kullanildi. Öncelikle HA ve 4sPEG 30 dakika UV isigina maruz birakildi. 15 ml falkon içeriside,2 ml (Smg/ml) hazirlanan HA, 2ml kollagen üzerine mikropipet ile pipetaj yaparak ilave edildi. Son olarak 500 pl 4sPEG karisim içerisine mikropipet ile ilave edildi ve iyice karistirildi. 1 saat etüvde 37°C'de %5 COz, kültüre edildikten sonra hazir hale geldi. PRP nin tavsandan elde edilmesinde tavsandan toplamda 18 ml kari kulagin marjinal veninden alinarak ve 2 ml citrate dextroz ile erken dönemde pihtilasmayi önlemek için karistirildi. Antikoagüle olan kan karisimi platelet ayirici kite yerlestirildi (Harvest SmartPrep, Plymouth, MA) sistemin gerektirdigi sekilde 14 dakika santrifuje edildi. Santrifujdan sonra PRP disposible tüp içerisinde elde edilip ve 1 ml PRP dilue edilip, platelet sayimi için Bulustaki ürün olusturulurken üretim yöntemi olarak su islem adimlari izlenmektedir; ilk olarak hyaluronik asit-kollagen enkapsülasyon malzemesinin hazirlanmasi esnasinda; kross linker olarak 4SPEG 37 °C'de yaklasik 8 dakika süreyle inkübe edilerek kullanilmaktadir. Çapraz baglama baslamadan önce ortama HA ve kollagen karistirilmakta ve HA kollagen içerisine penetre edilmektedir. 0.05 M asetik asit içerisinde 1000 pl kollagen ve PES içesinde 350 ul HA hazirlanmasi ve llVI sodyum hidroksit ile pH si 7.4 e ayarlanmasi saglanmakta ve PES de hazirlanmis 100 pl 4SPEG ilave edilmektedir. Karisimin 37 °C'de 1 saat jellesmenin beklenmektedir. Jel degredasyon testine göre farkli konsantrasyonlarda kollagen, HA ve 4SPEG kullanilabilmektedir. Mikroskopla gün asiri parçalanan kapsüller parçalanmayanlara göre orantilanmaktadir. Hücrenin kapsüllenmesi mikropipet yardimiyla veya peristaltik pompa araciligi ile yapilmaktadir ve ürün ortaya çikmaktadir. Kök hücre izolasyonunda ise; yag dokusundan kök hücrelerin primer kültürü asamasinda tavsandan temin edilen yag dokusu örnekleri kullanilmaktadir. Yag dokusu örnekler enzimatik parçalanma asamasi için küçük parçalara ayrilarak ve kollajenaz (%99,8 DMEM, %2 Kollajenaz) enziminde 1 saat bekletilmektedir. Enzimatik parçalama asamasindan sonra örnek 12000 RPM'de 2 dakika santrifüje edildikten sonra santrifüj tüpünün dip kismindan alinan hücreler 5mL DMEM ile (%88 DMEM, %10 FetalCalf Serum, %2 L-Glutamin, Streptomisin-Ampisilin) 12,5 cm2'lik hücre kültürü flasklarina aktarilarak etüve alinmaktadir( olmus fusiform morfolojiye sahip olmalari beklenmektedir. Hücreler belirlenen pasaja kadar, her pasajda flowsitometri uygulamasi yapilarak kök hücreler CD12, CD90, CD105 hücre yüzey reseptörlerinin varligina göre karakterize edilmektedir. Ayrica kök hücre negatif markerleri C034 ve CD45 kullanilmaktadir. Gerekli olursa diger CD19, CDll-B gibi markerlar da kullanilabilmektedir. Primer kondrosit izolasyonunda ise; tavsandan steril sartlarda alinan kikirdak dokulari laboratuvar ortaminda steril bistüriler yardimiyla küçük parçalara ayrilip 25cm2'lik flasklara ekilmektedir. Üzerine %89 DMEM (DuIbecco'sModifiedEaglesMedium), %10FBS( FetalBovine Serum), %1 penicillinstreptomycine içeren besiyeri eklenerek 1 hafta 37C° de %5 COZlik etüvde inkübe edilmektedir. Yeterli sayida hücre izole olduktan sonra flasklara tutunmus olan hücrelerin vasatlari atilip 0,5 ml tripsin EDTA ile muamele edilerek 4 dk inkübe edilmektedir. Inkübasyon sonunda hücreler kontrol edilip kalkmayan hücreler mekanik güç uygulanarak kaldirilacaktir. Steril falkon tüpe aktarilan hücrelerin üzerine tripsin aktivasyonunu inhibe etmek için 1 ml serum içeren besiyeri eklenmekte ve daha sonra 2500 rpm'de 2 dk santrifüj edilip elde edilen pellet üzerine her flask için 3 ml besiyeri eklenerek yeni flasklara pasajlanmaktadir. Hücre kültüründeki primer kondrositler, kültür ortamindan kaynaklanan farklilasmaya veya baska hücrelerce kontaminasyona karsi CD44, CD49c ve CD151 markerlariyla flow sitometride teyit edilmektedir. Kök hücrelerin, kondrositlerin, PRP' nin ayri ayri ve birlikte enkapsüllenmesi ve kök hücre/ kondrositler üzerindeki etkisi o Nekroz o Proliferasyon o Sitotoksisite o Kondrosit morfolojisi o GAG ölçümü o RT-PCR iler Kollagen tip II, Kollagen tip I, Agrecan, SOK-9 ve COIVIP sentezi o Western blot ile kollagen I ve kollagen II tayini ile belirlenmektedir. Son olarak uygulama eklem bölgesine enjeksiyon seklinde olmaktadir. Enkapsüle edilmis meznkimal kök hücre gerekli degerde eklem bölgesine enjekte edilmektedir. PRP uygulamasi için enkapsüle edilmis PRP veya PRP ve mezanimal kök hücrenin birlikte enkapsüle edilmesi ile enjeksiyon yapilmaktadirkol. Kondrosit uygulamasi için HA- Kollogen ile enkapsüle edilen kondrosit tek basina ya da PRP' ninde birlikte enkapsüle edilmesi ile enjekte edilmektedir. TR TR TR TR TR TR TR TR TR TR TR TR TR TR TRDESCRIPTION PRODUCT - METHOD - TECHNICAL FIELD CONTAINING HYALURONIC ACID - COLLAGEN-ENCAPSULATED MESENCHYMAL STEM CELL-PLATEL-RICH PLASMA AND CHONDROCYTES IN THE TREATMENT OF OSTEOARTHRITIS The invention relates to a product and its production method containing joint chondroprotective - regenerative agents such as hyaluronic acid - collagen-encapsulated mesenchymal stem cells, platelet-rich plasma, chondrocytes and their combination, which can be used in the treatment of joint osteoarthritis in the medical and pharmaceutical industries. KNOWN STATE OF THE ART RELATED TO THE INVENTION Osteoarthritis (0A) is a joint disease that mainly affects the joint cartilage. The deterioration of the joint cartilage causes pain and limitation of joint movements over time. Osteoarthritis (OA), a degenerative joint disease, is an inflammatory condition characterized by progressive erosion and fibrillation of articular cartilage and degeneration of subchondral bone. Treatment of cartilage structures is challenging due to the low healing potential and lack of vascularization in cartilage tissues. Therefore, cell-based therapies have been attracting interest and gaining popularity in regenerative medicine and dentistry in recent years. PURPOSE OF THIS INVENTION It relates to a product and production method that contains chondroprotective-regenerative agents and combinations of mesenchymal stem cells, platelet-rich plasma, chondrocytes and other chondroprotective-regenerative agents for joint structure encapsulated with hyaluronic acid - collagen used in the healthcare sector and that enables the survival of mesenchymal stem cells, platelet-rich plasma, chondrocytes and other chondroprotective-regenerative agents to be used in regenerative therapy and the release of bioactive molecules to the environment for a longer period of time through encapsulation. One purpose of the invention is to use the hyaluronic acid (HA)-collagen mixture as an encapsulation material due to its cartilage and joint protective effects. In this way, the effects of HA synthesized by synoviocytes, fibroblasts and chondrocytes, which are one of the main components of the extracellular matrix, on cell proliferation, tissue repair and cell migration will be utilized. Additionally, the main functions of hyaluronic acid include slowing the effects of inflammation in wound healing and supporting cell proliferation and re-epithelialization. It plays an important role as a lubricant in joint structure, protecting cartilage and assisting in the nourishment of the avascular portions of the cartilage and disc. Hyaluronic acid, normally used in joint treatment by increasing viscosity within the joint, is being used in encapsulation materials prepared in combination with collagen to exploit the beneficial effects of these materials on the joint. Another purpose of the invention is to enable the use of platelet-rich plasma (PRP) and its encapsulation with a hyaluronic acid (HA)-collagen mixture to produce a regenerative effect on cartilage degeneration. Thus, PRP (Platelet Rich Plasma) contributes to cell proliferation, chondrocyte differentiation, and tissue reorganization (remodeling). It has a potential healing effect. Another purpose of the invention is to enable the use of chondrocytes and their encapsulation with a hyaluronic acid (HA)-collagen mixture to create a chondrogenic effect on cartilage degeneration. This will increase chondrogenic activity and damaged tissue regeneration. Another purpose of the invention is to combine the synergistic effects of mesenchymal stem cells, PRP, chondrocytes, and their encapsulation with a hyaluronic acid-collagen encapsulation material, which are individually known to have regenerative and chondroprotective properties, to create a product that can be used as a regenerative and chondroprotective treatment method in the treatment of osteoarthritis. Another purpose of the invention is to develop a product that demonstrates that HA-collagen-encapsulated stem cells, PRP, and their synergistic effects, both individually and in combination, can be an alternative, shorter-lasting, and more definitive solution to known osteoarthritis treatment methods. Another purpose of the invention is to provide an alternative regenerative treatment method for osteoarthritis, either alone or in combination with HA-collagen and PRP encapsulation of primary chondrocytes, in addition to stem cells. The invention will become a preferred product in the industry in its current form. This will both ensure commercial success and offer the healthcare sector a rich treatment option for osteoarthritis. The invention allows bioactive molecules derived from stem cells, chondrocytes, and PRP trapped in the encapsulation material to be released into the joint space over a longer period of time, providing a longer-lasting effect. The encapsulation material allows substances in the synovial fluid to reach the stem cells, allowing the stem cells to persist in the environment for longer periods of time. The encapsulation material also contributes to joint viscosity and provides an additional effect. DETAILED DESCRIPTION OF THIS INVENTION The invention is a product and production method containing a combination of chondroprotective and regenerative agents encapsulated with hyaluronic acid and collagen, which can be used in the treatment of joint osteoarthritis. The chondroprotective and regenerative agent used in the invention for joint structure can be mesenchymal stem cells, platelet-rich plasma, chondrocytes, or combinations thereof. The results of the few studies on the use of stem cells in the treatment of joint osteoarthritis indicate that stem cell injection can stimulate cartilage regeneration and slow the progressive destruction of TIVIE. Based on this information, the present study used a hyaluronic acid (HA)-collagen mixture for stem cell encapsulation as an example. This invention also allows the encapsulation of fluids such as PRP, which contain numerous growth factors. In addition to the properties expected from encapsulation materials, the hyaluronic acid (HA)-collagen mixture used in this invention has been observed to have cartilage and joint-protective effects. Considering all these factors together, the invention demonstrates the synergistic effects of mesenchymal stem cells and PRP encapsulated in a chondroprotective hyaluronic acid-collagen mixture in vitro and in vivo in rabbit models of TMJ osteoarthritis. A special technique was used to create a TMJ osteoarthritis model. The resulting product has been used as a regenerative and chondroprotective treatment method. Although this technique was used to create a TMJ osteoarthritis model, it can be applied to all joint structures in the body as a regenerative and chondroprotective treatment method. The potential healing effects of platelet-rich plasma (PRP) have also led to its use in cartilage degeneration. PRP contributes to cell proliferation, chondrocyte differentiation, and tissue remodeling. In this invention, stem cell encapsulation is performed to protect the cells, allow the cells to exhibit synergistic effects by remaining together, allowing them to persist in the environment for longer periods of time, and allowing cell-derived bioactive molecules to be released into the environment for a longer period of time. The encapsulation material used in the invention should be biocompatible. It should enable nutrients to reach the cells and remain in the environment for the desired duration. During the creation of the invention, the effects of HA-collagen encapsulation materials on stem cells and their chondrogenic capacity on primary chondrocytes were evaluated. In addition, stem cells, PRP, and chondrocytes were encapsulated individually or together with HA-collagen and this combination was evaluated in terms of chondrogenic capacity. In these analyses; Many parameters such as cell morphology, glycosaminoglycan synthesis, collagen type I and type II synthesis, apoptosis, necrosis, proliferation, cytotoxicity, and chondrocyte viability were evaluated using current methods such as histology, histochemistry, immunohistochemistry, PCR, Western Blot, spectrophotometric analysis, Alamar Blue, Annexin V, and real-time cell analysis systems. Platelet-rich plasma (PRP) has been used in conjunction with stem cells to increase efficacy and accelerate healing in stem cell therapy. In this invention, encapsulation can also be performed using PRP alone instead of stem cells. Encapsulation can also be performed using chondrocytes instead of stem cells. Thus, HA-collagen alone or in combination with PRP encapsulation in primary chondrocytes, in addition to stem cells, is being proposed as an alternative regenerative treatment method for the treatment of osteoarthritis. PREPARATION AND CHARACTERIZATION OF THE HYALURONIC ACID-COLLAGEN ENCAPSULATING MATERIAL: HA/Collagen encapsulation material was developed to protect cells, ensure synergistic effects by allowing cells to remain together, maintain a longer viable environment, and release cell-derived bioactive molecules for a longer period of time. HA/Collagen encapsulation material is among the most preferred materials due to its biocompatibility, ability to deliver nutrients to cells, long-term retention, non-toxicity, and additional cartilage and joint-protective properties. In the preparation of the encapsulation material, collagen type II (Nutragen), hyaluronic acid, and 4-arm polyethylene glycol succinimidyl glutaramide (4sPEG) (Jenkem Technology) were used as a cross-linking agent. First, HA and 4sPEG were exposed to UV light for 30 minutes. 2 ml (5 mg/ml) of HA prepared in a 15 ml falcon was added to 2 ml of collagen by micropipetting. Finally, 500 µl of 4sPEG was added to the mixture using a micropipette and mixed thoroughly. The mixture was ready after 1 hour of incubation at 37°C and 5% CO2. To obtain PRP from rabbits, a total of 18 ml of PRP was collected from the marginal vein of the contralateral ear and mixed with 2 ml of citrate dextrose to prevent early clotting. The anticoagulated blood mixture was placed in a platelet separator kit (Harvest SmartPrep, Plymouth, MA) and centrifuged for 14 minutes as required by the system. After centrifugation, PRP was obtained in a disposable tube, 1 ml of PRP was diluted, and platelet counting was performed. The product of the invention is produced using the following steps: first, during the preparation of the hyaluronic acid-collagen encapsulation material, 4SPEG is used as a cross linker by incubating at 37°C for approximately 8 minutes. Before cross-linking begins, HA and collagen are mixed into the medium, and the HA penetrates into the collagen. 1000 µl of collagen in 0.05 M acetic acid and 350 µl of HA in PES are prepared. The pH is adjusted to 7.4 with IIVI sodium hydroxide, and 100 µl of 4SPEG prepared in PES are added. The mixture is allowed to gel at 37°C for 1 hour. Different concentrations of collagen, HA, and 4SPEG can be used based on the gel degradation test. Capsules that break down every other day are proportioned to those that do not. Cell encapsulation is achieved using a micropipette or a peristaltic pump, and the product is obtained. For stem cell isolation, rabbit adipose tissue samples are used in the primary culture phase of stem cell culture from adipose tissue. Adipose tissue samples are cut into small pieces for the enzymatic degradation stage and kept in collagenase (99.8% DMEM, 2% Collagenase) enzyme for 1 hour. After the enzymatic lysis step, the sample is centrifuged at 12000 RPM for 2 minutes. Then, the cells taken from the bottom of the centrifuge tube are transferred to 12.5 cm2 cell culture flasks with 5 mL DMEM (88% DMEM, 10% Fetal Calf Serum, 2% L-Glutamine, Streptomycin-Ampicillin) and placed in an incubator (they are expected to have a fusiform morphology). Flow cytometry is applied to the cells at each passage until the determined passage, and stem cells are characterized according to the presence of CD12, CD90, CD105 cell surface receptors. In addition, stem cell negative markers C034 and CD45 are used. If necessary, other markers such as CD19, CD11-B can also be used. In primary chondrocyte isolation; cartilage taken from rabbits under sterile conditions Tissues are cut into small pieces with sterile scalpels in a laboratory environment and seeded into 25 cm2 flasks. 89% DMEM (DuIbecco's Modified Eagles Medium), 10% FBS (Fetal Bovine Serum), 1% penicillin-streptomycin-containing medium is added and incubated for 1 week at 37°C in a 5% CO oven. After isolating a sufficient number of cells, the medium of the cells attached to the flasks is discarded and treated with 0.5 ml trypsin EDTA and incubated for 4 minutes. At the end of incubation, the cells are checked and any that do not rise are removed by applying mechanical force. 1 ml of serum-containing medium is added to the cells transferred to a sterile falcon tube to inhibit trypsin activation and then centrifuged at 2500 rpm for 2 minutes. 3 ml of medium is added to the pellet obtained for each flask. They are passaged into new flasks by adding them. Primary chondrocytes in cell culture are confirmed by flow cytometry with CD44, CD49c and CD151 markers against differentiation originating from the culture medium or contamination by other cells. Separate and combined encapsulation of stem cells, chondrocytes and PRP and their effects on stem cells/chondrocytes: o Necrosis o Proliferation o Cytotoxicity o Chondrocyte morphology o GAG measurement o RT-PCR procedures: Collagen type II, Collagen type I, Aggrecan, SOK-9 and COIVIP synthesis; o Western blot for collagen I and collagen II determination. Finally, the application is by injection into the joint area. Encapsulated meschymal stem cells are injected into the joint area at the required level. For PRP application, injection is performed by encapsulating PRP or by co-encapsulating PRP and meschymal stem cells. For chondrocyte application, chondrocytes encapsulated with HA-Collagen are injected alone or together with PRP. TR TR TR TR TR TR TR TR TR TR TR TR TR TR TR TR

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