IT202300000891A1 - BONE REPAIR DEVICES, IN PARTICULAR JOINT PROSTHESES AND SKELETAL OSTEOSYNTHESIS DEVICES - Google Patents

BONE REPAIR DEVICES, IN PARTICULAR JOINT PROSTHESES AND SKELETAL OSTEOSYNTHESIS DEVICES Download PDF

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Publication number
IT202300000891A1
IT202300000891A1 IT102023000000891A IT202300000891A IT202300000891A1 IT 202300000891 A1 IT202300000891 A1 IT 202300000891A1 IT 102023000000891 A IT102023000000891 A IT 102023000000891A IT 202300000891 A IT202300000891 A IT 202300000891A IT 202300000891 A1 IT202300000891 A1 IT 202300000891A1
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Prior art keywords
devices
prp
osteosynthesis
skeletal
devices according
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IT102023000000891A
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Italian (it)
Inventor
Laura Mazzucco
Andrea BARBANERA
Valerio Vallana
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Sps S R L
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Priority to IT102023000000891A priority Critical patent/IT202300000891A1/en
Publication of IT202300000891A1 publication Critical patent/IT202300000891A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3616—Blood, e.g. platelet-rich plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
    • A61L27/3645—Connective tissue
    • A61L27/365—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/005—Ingredients of undetermined constitution or reaction products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Botany (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Materials For Medical Uses (AREA)

Description

DESCRIZIONE dell?invenzione industriale dal titolo: DESCRIPTION of the industrial invention entitled:

?Dispositivi di riparazione ossea, in particolare protesi articolari e mezzi di osteosintesi scheletrica? ?Bone repair devices, in particular joint prostheses and skeletal osteosynthesis devices?

TESTO DELLA DESCRIZIONE DESCRIPTION TEXT

Campo dell'invenzione Field of invention

La presente invenzione si riferisce ai dispositivi di riparazione ossea, in particolare alle protesi articolari e ai mezzi di osteosintesi scheletrica con espressa esclusione delle gabbie intersomatiche per stabilizzazione vertebrale mediante fusione di due corpi vertebrali. The present invention relates to bone repair devices, in particular to joint prostheses and skeletal osteosynthesis means with the express exclusion of interbody cages for vertebral stabilization by fusion of two vertebral bodies.

I dispositivi di cui alla presente invenzione includono ad esempio in modo non esaustivo, oltre alle protesi articolari, le protesi cranioplastiche, nonch? le viti e placche per osteosintesi impiegate nel settore della chirurgia delle ossa lunghe e nella chirurgia maxillofacciale. The devices of the present invention include, for example but not limited to, joint prostheses, cranioplasty prostheses, as well as osteosynthesis screws and plates used in the field of long bone surgery and maxillofacial surgery.

Stato della tecnica State of the art

A seguito dell?applicazione chirurgica di protesi articolari e di mezzi di osteosintesi scheletrica la zona ossea interessata ? normalmente soggetta a infiammazioni e in taluni casi anche a infezioni. La ricrescita ossea pu? inoltre risultare insufficiente ed inidonea a inglobare nel tempo in modo efficace le protesi e i mezzi di osteosintesi impiantati. Following the surgical application of joint prostheses and skeletal osteosynthesis devices, the affected bone area is normally subject to inflammation and in some cases even to infections. Bone regrowth may also be insufficient and unsuitable to effectively incorporate the implanted prostheses and osteosynthesis devices over time.

Nella domanda di brevetto italiana n. 102022000020160 a nome della stessa Richiedente, non pubblicata alla data di deposito della presente domanda, ? proposta una gabbia intersomatica per stabilizzazione vertebrale formata da un corpo entro la quale ? alloggiato un inserto incorporante sostanze a lento rilascio prolungato includenti specifici promotori di ricrescita ossea, oltre che eventuali farmaci anti-infiammatori e anti-infezione. In the Italian patent application no. 102022000020160 in the name of the same Applicant, not published at the date of filing of the present application, an intersomatic cage for vertebral stabilization is proposed consisting of a body within which is housed an insert incorporating slow-release prolonged-release substances including specific bone regrowth promoters, as well as possible anti-inflammatory and anti-infection drugs.

Sintesi dell'invenzione Summary of the invention

Gli inventori, gli stessi della citata domanda di brevetto italiana n. 102022000020160, hanno sorprendentemente constatato che gli stessi promotori di ricrescita ossea previsti nel caso della gabbia intersomatica vertebrale possono essere vantaggiosamente applicati anche alle protesi articolari e ai mezzi di osteosintesi scheletrica di cui alla presente invenzione. The inventors, the same as those of the aforementioned Italian patent application no. 102022000020160, have surprisingly found that the same bone regrowth promoters envisaged in the case of the vertebral interbody cage can also be advantageously applied to the joint prostheses and skeletal osteosynthesis means referred to in the present invention.

L'invenzione ha pertanto per oggetto un dispositivo di riparazione ossea del tipo sopra indicato, e con esclusione delle gabbie intersomatiche vertebrali, il cui corpo ? dotato di un inserto esposto all?esterno ed incorporante promotori di ricrescita ossea a lento rilascio prolungato scelti fra derivati ematici ed emocomponenti autologhi e allogenici, come in particolare: concentrato piastrinico, concentrato di cellule midollari, cellule staminali e mononucleate da cresta iliaca, concentrati di fattori di crescita e proteine, concentrati leucomonocitari e loro combinazioni. The invention therefore has as its object a bone repair device of the type indicated above, and with the exclusion of vertebral interbody cages, the body of which is equipped with an insert exposed to the outside and incorporating slow-release prolonged-release bone regrowth promoters selected from autologous and allogenic blood derivatives and blood components, such as in particular: platelet concentrate, marrow cell concentrate, iliac crest stem and mononuclear cells, growth factor and protein concentrates, leukomonocyte concentrates and combinations thereof.

Il corpo delle protesi articolari o dei mezzi di osteosintesi scheletrica secondo l?invenzione, normalmente di titanio o di un analogo materiale biocompatibile, ? formato con almeno un ricettacolo contenente l?inserto il quale pu? consistere in un materiale spugnoso o filamentoso o poroso imbibito con i derivati ematici e gli emocomponenti autologhi e allogenici. The body of the joint prostheses or skeletal osteosynthesis devices according to the invention, normally made of titanium or a similar biocompatible material, is formed with at least one receptacle containing the insert which may consist of a spongy or filamentous or porous material soaked with autologous and allogenic blood derivatives and blood components.

Descrizione dettagliata dell'invenzione Detailed description of the invention

Le protesi articolari e i mezzi di osteosintesi scheletrica che costituiscono i dispositivi di riparazione ossea secondo l?invenzione sono generalmente noti e non verranno per brevit? descritti in dettaglio. Le protesi possono essere del tipo usualmente applicato alle articolazioni di anca, ginocchio, caviglia, spalla, gomito e polso, e i mezzi di osteosintesi possono consistere in viti e placche tradizionalmente impiegate nel settore della chirurgia delle ossa lunghe e nella chirurgia maxillofacciale, nonch? in protesi cranioplastiche. The joint prostheses and skeletal osteosynthesis means that constitute the bone repair devices according to the invention are generally known and will not be described in detail for the sake of brevity. The prostheses may be of the type usually applied to the hip, knee, ankle, shoulder, elbow and wrist joints, and the osteosynthesis means may consist of screws and plates traditionally used in the field of long bone surgery and maxillofacial surgery, as well as cranioplastic prostheses.

In tutti i casi si tratta di almeno un corpo di materiale biocompatibile, ad esempio titanio, eventualmente anche realizzato mediante tecniche additive del tipo sinterizzazione di polveri, il quale ? formato con almeno un ricettacolo entro il quale ? alloggiato almeno un inserto esposto verso l?esterno attraverso aperture del ricettacolo. L?inserto ? convenientemente formato da un materiale spugnoso o filamentoso o poroso, o analoghi materiali. In all cases, it is at least one body of biocompatible material, for example titanium, possibly also made using additive techniques such as powder sintering, which is formed with at least one receptacle within which is housed at least one insert exposed to the outside through openings in the receptacle. The insert is conveniently formed from a spongy or filamentous or porous material, or similar materials.

L?inserto incorpora o ? imbibito con sostanze terapeutiche a lento rilascio prolungato scelte nelle classi dei farmaci anti-infiammatori, anti-infezione e, particolarmente o anche esclusivamente, promotori di ricrescita ossea. A tale effetto l?inserto pu? essere in un unico pezzo suddiviso in zone distinte per le eventuali diverse sostanze terapeutiche, oppure pu? essere formato da settori autonomi e separati, ciascuno incorporante la rispettiva sostanza. The insert incorporates or is soaked with slow-release prolonged-release therapeutic substances chosen from the classes of anti-inflammatory, anti-infection and, particularly or even exclusively, bone regrowth promoters. To this end, the insert may be a single piece divided into distinct zones for any different therapeutic substances, or it may be made up of autonomous and separate sectors, each incorporating the respective substance.

I promotori di ricrescita ossea a lento rilascio prolungato consistono, secondo la caratteristica peculiare dell?invenzione, in fattori di ricrescita gi? naturalmente presenti all?interno del corpo umano: in particolare essi sono scelti fra derivati ematici ed emocomponenti autologhi e allogenici, e/o loro combinazioni. According to the peculiar characteristic of the invention, slow-release bone regrowth promoters consist of regrowth factors already naturally present within the human body: in particular, they are selected from autologous and allogenic blood derivatives and blood components, and/or combinations thereof.

Pi? specificamente, secondo l?invenzione i fattori di ricrescita ossea possono essere scelti fra concentrato piastrinico (Plasma Ricco di Piastrine PRP), concentrato di cellule midollari, cellule staminali e mononucleate da cresta iliaca, concentrati di fattori di crescita e proteine, concentrati leucomonocitari, e loro combinazioni. More specifically, according to the invention, bone regrowth factors can be selected from platelet concentrate (Platelet Rich Plasma PRP), bone marrow cell concentrate, iliac crest stem and mononuclear cells, growth factor and protein concentrates, leukomonocyte concentrates, and combinations thereof.

Il PRP pu? essere autologo oppure allogenico e il PRP allogenico pu? anche essere liofilizzato. PRP can be autologous or allogenic and allogenic PRP can also be freeze-dried.

Queste sostanze di derivazione biologica, autologi o allogenici, possono essere iniettate nell?inserto del corpo della protesi articolare o del mezzo di osteosintesi preventivamente, in modo da renderlo pronto per l?uso, oppure all?atto dell?impiantazione chirurgica. These substances of biological origin, autologous or allogenic, can be injected into the insert of the body of the joint prosthesis or of the osteosynthesis device in advance, in order to make it ready for use, or at the time of surgical implantation.

Naturalmente i particolari di costruzione e le forme di realizzazione delle protesi articolari e dei mezzi di osteosintesi potranno essere i pi? vari nell'ambito dell'invenzione cos? come definita nelle rivendicazioni che seguono. Naturally, the construction details and embodiments of the joint prostheses and osteosynthesis means may be the most varied within the scope of the invention as defined in the following claims.

Claims (5)

RIVENDICAZIONI 1. Dispositivi di riparazione ossea, in particolare protesi articolari e mezzi di osteosintesi scheletrica con esclusione delle gabbie intersomatiche per stabilizzazione vertebrale, comprendenti un corpo provvisto di almeno un inserto incorporante promotori di ricrescita ossea a lento rilascio prolungato, caratterizzati dal fatto che detti promotori di ricrescita ossea sono scelti fra derivati ematici ed emocomponenti autologhi e allogenici, come in particolare: concentrato piastrinico (PRP), concentrato di cellule midollari, cellule staminali e mononucleate da cresta iliaca, concentrati di fattori di crescita e proteine, concentrati leucomonocitari, e loro combinazioni.1. Bone repair devices, in particular joint prostheses and skeletal osteosynthesis devices with the exception of interbody cages for vertebral stabilization, comprising a body equipped with at least one insert incorporating slow-release prolonged-release bone regrowth promoters, characterized in that said bone regrowth promoters are selected from autologous and allogenic blood derivatives and blood components, such as in particular: platelet concentrate (PRP), marrow cell concentrate, iliac crest stem and mononuclear cells, growth factor and protein concentrates, leukomonocyte concentrates, and combinations thereof. 2. Dispositivi secondo la rivendicazione 1, caratterizzati dal fatto che il PRP ? autologo.2. Devices according to claim 1, characterised in that the PRP is autologous. 3. Dispositivi secondo la rivendicazione 1, caratterizzati dal fatto che il PRP ? allogenico.3. Devices according to claim 1, characterised in that the PRP is allogenic. 4. Dispositivi secondo la rivendicazione 3, caratterizzati dal fatto che PRP allogenico pu? essere liofilizzato.4. Devices according to claim 3, characterized in that the allogeneic PRP can be freeze-dried. 5. Dispositivi secondo la rivendicazione 1, caratterizzati dal fatto che detto inserto ? di un materiale spugnoso o filamentoso o poroso. 5. Devices according to claim 1, characterised in that said insert is made of a spongy or filamentous or porous material.
IT102023000000891A 2023-01-23 2023-01-23 BONE REPAIR DEVICES, IN PARTICULAR JOINT PROSTHESES AND SKELETAL OSTEOSYNTHESIS DEVICES IT202300000891A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005004886A1 (en) * 2003-07-09 2005-01-20 Sdgi Holdings, Inc. Isolation of bone marrow fraction rich in connective tissue growth components and the use thereof to promote connective tissue formation
WO2017186692A1 (en) * 2016-04-25 2017-11-02 Pharmaceutical Business Consultants Limited Vascularity affinity precursor structure for musculo-skeletal tissue healing

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005004886A1 (en) * 2003-07-09 2005-01-20 Sdgi Holdings, Inc. Isolation of bone marrow fraction rich in connective tissue growth components and the use thereof to promote connective tissue formation
WO2017186692A1 (en) * 2016-04-25 2017-11-02 Pharmaceutical Business Consultants Limited Vascularity affinity precursor structure for musculo-skeletal tissue healing

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LI JUNDA ET AL: "Evaluation of 3D-Printed Polycaprolactone Scaffolds Coated with Freeze-Dried Platelet-Rich Plasma for Bone Regeneration", MATERIALS, vol. 10, no. 7, 19 July 2017 (2017-07-19), pages 831, XP093069100, DOI: 10.3390/ma10070831 *

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