WO2016208675A1 - Plasma riche en plaquettes lyophilisé et son utilisation - Google Patents

Plasma riche en plaquettes lyophilisé et son utilisation Download PDF

Info

Publication number
WO2016208675A1
WO2016208675A1 PCT/JP2016/068682 JP2016068682W WO2016208675A1 WO 2016208675 A1 WO2016208675 A1 WO 2016208675A1 JP 2016068682 W JP2016068682 W JP 2016068682W WO 2016208675 A1 WO2016208675 A1 WO 2016208675A1
Authority
WO
WIPO (PCT)
Prior art keywords
platelet
rich plasma
prp
freeze
concentration
Prior art date
Application number
PCT/JP2016/068682
Other languages
English (en)
Japanese (ja)
Inventor
泉 朝比奈
佑哉 中谷
秀樹 縣
吉慶 住田
喬充 古賀
Original Assignee
株式会社Ｔｅｓホールディングス
国立大学法人長崎大学
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社Ｔｅｓホールディングス, 国立大学法人長崎大学 filed Critical 株式会社Ｔｅｓホールディングス
Publication of WO2016208675A1 publication Critical patent/WO2016208675A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/16—Blood plasma; Blood serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • 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

Definitions

  • the present invention relates to freeze-dried platelet-rich plasma and use thereof.
  • This application claims priority based on Japanese Patent Application No. 2015-125916 filed in Japan on June 23, 2015, the contents of which are incorporated herein by reference.
  • platelet-rich plasma is effective for regenerative treatment of various tissues such as skin, mucous membrane, bone and periodontal tissue.
  • platelet-rich plasma basically needs to be prepared at the time of use, which has hindered its clinical spread. Therefore, a technique for preserving platelet-rich plasma is required.
  • Patent Document 1 includes platelet-rich plasma that has been coated on a solid support and then freeze-dried, and is used after the platelet-rich plasma has been refrigerated for at least one day after being freeze-dried. The material for regenerative treatment is described.
  • Non-Patent Document 1 describes platelet-rich plasma freeze-dried after absorption of trehalose.
  • the platelet-rich plasma described in Patent Document 1 since the platelet-rich plasma described in Patent Document 1 has a solid support as an essential component, it may be difficult to gel the platelet-rich plasma, for example.
  • the platelet-rich plasma described in Non-Patent Document 1 has a complicated manufacturing process, and a complicated procedure may be required at the time of reconstitution.
  • an object of the present invention is to provide platelet-rich plasma that can be stored and can be produced and used more easily and a method for producing the same.
  • the present invention is as follows. (1) Platelet-rich plasma that is lyophilized and substantially free of exogenous low molecular sugars. (2) The platelet-rich plasma according to (1), which is not coated on a solid support. (3) A platelet-rich plasma composition containing the platelet-rich plasma according to (1) or (2) and a solvent. (4) The platelet-rich plasma composition according to (3), wherein the platelet concentration is 200 to 1000 ( ⁇ 10 4 cells / ⁇ L). (5) A coagulum of the platelet-rich plasma composition according to (3) or (4). (6) A method for producing freeze-dried platelet-rich plasma, comprising a step of freezing platelet-rich plasma at ⁇ 20 ° C. or lower and a step of freeze-drying the frozen platelet-rich plasma.
  • 10 is a graph showing the results of Experimental Example 4.
  • 10 is a graph showing the results of Experimental Example 4.
  • 10 is a graph showing the results of Experimental Example 4. It is a figure which shows the photograph which shows the result of Experimental example 5, and an evaluation result.
  • (A) is a photograph showing an incision line of the head of a nude mouse in Experimental Example 6, and FIG. 5
  • FIG. 5 (b) is a photograph showing a state in which a sample is transplanted into the nude mouse in Experimental Example 6,
  • FIG. (C) is a photograph of a nude mouse immediately after transplanting a sample in Experimental Example 6.
  • A) is a photomicrograph showing the results of hematoxylin and eosin staining of a sample taken from a nude mouse in Experimental Example 6.
  • (B) is an enlarged view of a region surrounded by a square in (a).
  • the scale bar indicates 200 ⁇ m.
  • (A) is a photomicrograph showing the results of hematoxylin and eosin staining of a sample taken from a nude mouse in Experimental Example 6.
  • (B) is an enlarged view of a region surrounded by a square in (a).
  • the scale bar indicates 200 ⁇ m.
  • (A) is a photomicrograph showing the results of hematoxylin and eosin staining of a sample taken from a nude mouse in Experimental Example 6.
  • (B) is an enlarged view of a region surrounded by a square in (a).
  • the scale bar indicates 200 ⁇ m.
  • (A) is a photomicrograph showing the results of hematoxylin and eosin staining of a sample taken from a nude mouse in Experimental Example 6.
  • (B) is an enlarged view of a region surrounded by a square in (a). The scale bar indicates 200 ⁇ m. It is a graph which shows the calculation result of the bone formation rate in Experimental example 6.
  • the present invention provides platelet rich plasma that is lyophilized and substantially free of exogenous low molecular sugars.
  • the freeze-dried platelet-rich plasma according to the present embodiment can be stored and can be more easily produced and used.
  • being storable means that the activity can be maintained even when stored at 4 ° C. for one month or longer.
  • Examples of the activity of platelet-rich plasma include gel forming activity described later, the activity of growth factors contained in platelet-rich plasma, and the like.
  • examples of the low molecular sugar include sugars having an action of improving resistance to freezing of animal cells and the like, such as trehalose, sucrose, and maltose.
  • the phrase “substantially free of exogenous low-molecular sugars” means that sugars that improve freezing resistance are not added from the outside during freeze-drying of platelet-rich plasma. The presence of sugar is acceptable.
  • an anticoagulant may be added to the blood at the time of collecting blood used for the production of platelet-rich plasma, and glucose may be added to the anticoagulant. Is not included in exogenous low-molecular sugars.
  • Non-Patent Document 1 As described in Non-Patent Document 1, conventionally, in order to preserve platelet-rich plasma by freeze-drying, it has been thought that low molecular sugars such as trehalose need to be absorbed in advance by platelets. On the other hand, the inventors have found that platelet-rich plasma can be lyophilized while maintaining the activity without performing treatment such as absorption of low-molecular sugars into platelets.
  • the lyophilized product of this embodiment can be produced more easily because it does not require treatment such as absorption of low molecular sugars by platelets. Moreover, the lyophilized body of platelet-rich plasma described in Non-Patent Document 1 needs to be prehydrated by allowing it to stand in a saturated water vapor environment at 37 ° C. before reconstitution. On the other hand, when reconstituting the freeze-dried platelet-rich plasma according to the present embodiment, prehydration is not essential and can be used more easily.
  • freeze-dried body of this embodiment is not coated on the solid support.
  • the platelet-rich plasma of this embodiment can be lyophilized and stably stored even if it is not coated on a solid support.
  • the freeze-dried body of the present embodiment includes “platelet-rich plasma freeze-dried after being coated on a solid support, and used after the platelet-rich plasma has been refrigerated for at least one day after being freeze-dried. It may not be “a material for regenerative treatment”.
  • the solid support means, for example, a short-absorbable biodegradable polymer or bioabsorbable polymer such as polyglycolic acid, polylactic acid, and copolymers thereof; propanediol, poly (L-lactide-co-) Long-degradable biodegradable polymers or bioabsorbable polymers such as epsilon-caprolactone), polycaprolactone and copolymers thereof; polybutylene succinate, polyvinyl alcohol, chitosan and other biodegradable polymers or bioabsorbable polymers; Examples include a support made of silk, which is a non-biodegradable polymer.
  • Examples of the shape of the solid support include fiber products such as woven fabrics, knitted fabrics, nonwoven fabrics, stitches, cotton, cloth, paper, and filters; and porous substrates including granular materials and foams.
  • Examples of the textile products include woven fabrics such as meshes and gauze fabrics; those commonly used as wound dressings such as knitted fabrics, nonwoven fabrics, stitches, and cotton.
  • being coated means that the solid support is covered with a solution containing platelet-rich plasma. That is, being coated means that the platelet-rich plasma is coagulated on the surface of the solid support, the above solution is permeated by capillary action through the fiber gaps and pores of the solid support, The solid support is dissolved or decomposed in the presence of the above solution, and the above solution is absorbed by the solid support by forming a layer or membrane of the above solution on the surface of the solid support. means.
  • the present invention provides a platelet-rich plasma composition containing the platelet-rich plasma and solvent described above. It can also be said that the platelet-rich plasma composition of the present embodiment is a reconstituted platelet-rich plasma obtained by adding a solvent to the above-mentioned freeze-dried platelet-rich plasma.
  • the reconstituted platelet-rich plasma of this embodiment is fresh platelet-rich plasma that has not been lyophilized even after the freeze-dried form of platelet-rich plasma has been stored for a long time. Can exhibit the same activity.
  • the platelets contained in the platelet-rich plasma obtained by reconstitution of the above-mentioned freeze-dried platelet-rich plasma have a history of freeze-drying once. Therefore, it is predicted that the surface structure of platelets is different from that of fresh platelet-rich plasma.
  • the solvent examples include sterilized water, physiological saline, and phosphate buffer.
  • the solvent may be added to the lyophilized platelet-rich plasma in an amount that is equivalent to the platelet-rich plasma before lyophilization, or may be added in an amount that is less than that before lyophilization. In the former case, platelet-rich plasma having a platelet concentration equivalent to that before lyophilization is obtained. In the latter case, platelet-rich plasma having a platelet concentration higher (concentrated) than platelet-rich plasma before lyophilization is obtained.
  • the reconstituted platelet-rich plasma of this embodiment may have a platelet concentration of 200-1000 ( ⁇ 10 4 cells / ⁇ L).
  • the platelet concentration of general platelet-rich plasma is 100 to 200 ( ⁇ 10 4 cells / ⁇ L). Therefore, platelet-rich plasma having a platelet concentration of 200 to 1000 ( ⁇ 10 4 cells / ⁇ L) is concentrated about 2 to 5 times compared with general platelet-rich plasma.
  • the reconstituted platelet-rich plasma of this embodiment may have a platelet concentration of 200 to 800 ( ⁇ 10 4 cells / ⁇ L) or 200 to 600 ( ⁇ 10 4 cells / ⁇ L).
  • concentrated platelet-rich plasma can more strongly promote tissue regeneration in vivo compared to unconcentrated platelet-rich plasma.
  • the present invention provides a clot (gel) of the platelet-rich plasma composition described above.
  • the gel according to the present embodiment is obtained by reconstituting a platelet-rich plasma with a solvent and further coagulating it.
  • the gel of the present embodiment can be produced, for example, by adding calcium chloride to reconstituted platelet-rich plasma and activating and coagulating a blood coagulation factor contained in the plasma.
  • prothrombin contained in plasma is changed to thrombin by the action of thromboplastin released from platelets and calcium ions, and fibrinogen in plasma becomes fibrin by the enzyme activity of thrombin.
  • Fibrin binds to each other by the action of calcium ions and the like, forming a network structure and solidifying.
  • the gel of the present embodiment serves as a scaffold for cells, and can keep platelet-rich plasma locally for a long period of time, and can gradually release growth factors and the like contained in the platelet-rich plasma. It is useful for regenerative treatment of various tissues such as bone and periodontal tissue.
  • a bone filling material or the like may be added to the platelet-rich plasma.
  • autologous serum may be added to platelet-rich plasma to improve clotting activity.
  • the present invention provides a method for producing freeze-dried platelet-rich plasma comprising the steps of freezing platelet-rich plasma at ⁇ 20 ° C. or lower and freeze-drying the frozen platelet-rich plasma. provide. It can be said that the production method of this embodiment is a method for preserving platelet-rich plasma.
  • Platelet rich plasma can be prepared by a general method. Specifically, first, peripheral venous blood is collected from a patient. At this time, an anticoagulant is added to the collected peripheral blood.
  • an anticoagulant a common one can be used, and examples thereof include citric acid solution, sodium fluoride, ethylenediaminetetraacetic acid (EDTA) solution, ACD (acid-citrate-dextrose) solution, heparin and the like. .
  • the peripheral blood to which the anticoagulant has been added is placed in a centrifuge tube and centrifuged, for example, at 4 ° C. and 1000 to 1200 ⁇ g for 10 to 30 minutes. After centrifugation, the peripheral blood is separated into a plasma layer, a white blood cell layer (buffy coat), and a red blood cell layer in order from the top. Since platelets are accumulated above the buffy coat, platelet-rich plasma can be obtained by collecting the vicinity thereof. For example, on the basis of the position of the buffy coat, mark 1/10 volume above the blood in the centrifuge tube, remove the platelet blood plasma above the mark, and remove platelets located below the mark The layer and buffy coat may be collected and used as platelet rich plasma.
  • platelet-rich plasma may be collected from peripheral blood using a commercially available instrument (for example, “Gravational Platelet Separation System”, Biomet).
  • Step of freezing platelet-rich plasma the platelet-rich plasma is frozen.
  • the freezing temperature may be ⁇ 50 ° C. or lower, ⁇ 80 ° C. or lower, ⁇ 150 ° C. or lower, or ⁇ 190 ° C. or lower.
  • a commercially available deep freezer can be used.
  • ⁇ 190 ° C. or lower for example, liquid nitrogen can be used.
  • the frozen platelet-rich plasma is lyophilized.
  • the lyophilization is preferably performed within a few days after the platelet-rich plasma is frozen.
  • the platelet-rich plasma may be freeze-dried immediately after freezing or may be freeze-dried 24 hours after freezing.
  • Freeze-drying can be performed by a general method.
  • lyophilization may be performed using a freeze dryer (model “EYELA FD-1000”, Tokyo Rika Kikai Co., Ltd.) at ⁇ 50 ° C. and 15 Pa.
  • the platelet-rich plasma after lyophilization may be stored at room temperature, but is preferably stored at a lower temperature. For example, it may be stored at 4 ° C. or may be stored at ⁇ 20 ° C., for example.
  • peripheral blood to which an anticoagulant was added was placed in a centrifuge tube and centrifuged with a centrifuge (trade name “Medifuge”, manufactured by Silfrent). After centrifugation, the peripheral blood was separated into a plasma layer, a white blood cell layer (buffy coat), and a red blood cell layer in order from the top. Subsequently, the position of the buffy coat was used as a reference to mark an upper portion of 1/10 volume of blood in the centrifuge tube. Above the above mark, it was removed because it was sputum platelet plasma. Subsequently, the platelet layer and the buffy coat located below the mark were collected and used as platelet-rich plasma.
  • platelet-rich plasma may be referred to as (Platelet Rich Plasma, PRP).
  • Example 3 Freeze-drying of platelet-rich plasma
  • the platelet-rich plasma prepared in Experimental Example 1 was frozen in a deep freezer at ⁇ 80 ° C. for 24 hours, and then freeze-dried (model “EYELA FD-1000”, Tokyo Rika Instruments) at ⁇ 50 ° C. and 15 Pa. Lyophilized to obtain a lyophilized platelet-rich plasma.
  • Example 4 Measurement of growth factor concentration in platelet-rich plasma
  • a fresh platelet-rich plasma prepared in the same manner as in Experimental Example 1 was frozen at -20 degrees and thawed at 37 ° C. twice to extract growth factors, and a reference platelet-rich plasma (hereinafter referred to as “reference PRP”). ).
  • the freeze-dried platelet-rich plasma prepared in Experimental Example 3 was stored at 4 ° C. for 1 month and then reconstituted at the same magnification by adding sterilized water (hereinafter referred to as “ ⁇ 1FD-PRP”).
  • ⁇ 1FD-PRP sterilized water
  • lyophilized platelet-rich plasma prepared in Experimental Example 3 at 4 ° C. for 1 month, and then reconstituted to 1/3 volume by adding sterile water (platelet concentration is 3 times concentrated)
  • ⁇ 3FD-PRP was prepared.
  • vascular endothelial growth factor The concentration of vascular (secondary growth factor, VEGF) was measured by an ELISA method using a commercially available kit. More specifically, a kit (trade name “Quantikine Human PDGF-BB ELISA”, catalog number “DBB00”, R & D Systems) was used for measurement of PDGF-BB. A kit (trade name “Quantikine Human TGF- ⁇ 1 ELISA”, catalog number “DBB00”, R & D Systems) was used for the measurement of TGF- ⁇ 1.
  • VEGF measurement was used for VEGF measurement.
  • concentration of each growth factor was measured four times for each of the reference PRP, x1FD-PRP and x3FD-PRP derived from three donors.
  • FIG. 1 is a graph showing the measurement results of the PDGF-BB concentration in the standard PRP, ⁇ 1FD-PRP, and ⁇ 3FD-PRP.
  • the graph shows the average value
  • the error bar shows the standard deviation.
  • “ns” indicates that there is no significant difference with a risk rate of less than 1%.
  • the numbers in the figure indicate relative values of the PDGF-BB concentration with the PDGF-BB concentration in the reference PRP being 1.
  • the concentration of PDGF-BB in x1FD-PRP was equivalent to the concentration of PDGF-BB in the reference PRP.
  • the concentration of PDGF-BB in x3FD-PRP was shown to be about 2.8 times the concentration of PDGF-BB in reference PRP.
  • FIG. 2 is a graph showing the measurement results of the concentration of TGF- ⁇ 1 in the standard PRP, ⁇ 1FD-PRP and ⁇ 3FD-PRP.
  • the graph shows the average value
  • the error bar shows the standard deviation.
  • “ns” indicates that there is no significant difference with a risk rate of less than 1%.
  • the numbers in the figure show the relative values of the TGF- ⁇ 1 concentration, where the TGF- ⁇ 1 concentration in the reference PRP is 1.
  • the concentration of PDGF-BB in x1FD-PRP was equivalent to the concentration of TGF- ⁇ 1 in the reference PRP. Further, it was shown that the concentration of TGF- ⁇ 1 in ⁇ 3FD-PRP was about 2.5 times the concentration of TGF- ⁇ 1 in reference PRP.
  • FIG. 3 is a graph showing the measurement results of the concentration of VEGF in the standard PRP, ⁇ 1FD-PRP, and ⁇ 3FD-PRP.
  • the graph shows the average value
  • the error bar shows the standard deviation.
  • “**” indicates that there is a significant difference at a risk rate of less than 1%.
  • the numbers in the figure indicate relative values of the concentration of VEGF, where the concentration of VEGF in the reference PRP is 1.
  • the concentration of VEGF in x1FD-PRP was lower than the concentration of VEGF in the reference PRP. Further, it was shown that the concentration of VEGF in x3FD-PRP was about 1.5 times the concentration of VEGF in reference PRP.
  • ⁇ -tricalcium phosphate (trade name “Osferion (registered trademark) G1”, manufactured by Olympus) 25 mg, which is a bone filling material, is added to the above-mentioned reconstituted platelet-rich plasma or fresh platelet-rich plasma 100 ⁇ L. Then, 10 ⁇ L of autoserum and 10 ⁇ L of 2 w / v% calcium chloride aqueous solution were mixed, and the gelation state 10 minutes after mixing was evaluated according to the following criteria. +: Completely solidified. ⁇ : Partially solidified. -: Not solidified.
  • FIG. 4 shows a photograph of the mixture after 10 minutes of mixing, a photograph of the platelet-rich plasma gel taken out with tweezers after 10 minutes of mixing, and an evaluation result of the gelation state of the platelet-rich plasma.
  • FIG. 5 (a) is a photograph showing the incision line of the head of a nude mouse
  • FIG. 5 (b) is a photograph showing a state of transplanting the sample into the nude mouse
  • FIG. 5 (c) is a photograph of the sample. It is the photograph of the nude mouse immediately after transplanting.
  • Osteogenesis rate (%) Bone formation area ( ⁇ m 2 ) / Transplant sample area ( ⁇ m 2 ) ⁇ 100 (1)
  • FIG. 6 (a) is a photomicrograph showing the results of hematoxylin and eosin staining of a ⁇ -TCP sample taken from a nude mouse.
  • FIG. 6B is an enlarged view of a region surrounded by a square in FIG. The scale bar indicates 200 ⁇ m.
  • FIG. 7 (a) is a photomicrograph showing the results of hematoxylin and eosin staining of a fresh PRP sample taken from a nude mouse.
  • FIG. 7B is an enlarged view of a region surrounded by a square in FIG. The scale bar indicates 200 ⁇ m.
  • FIG. 8 (a) is a photomicrograph showing the results of hematoxylin and eosin staining of a x1FD-PRP sample taken from nude mice.
  • FIG. 8B is an enlarged view of a region surrounded by a square in FIG. The scale bar indicates 200 ⁇ m.
  • FIG. 9 (a) is a micrograph showing the results of hematoxylin and eosin staining of a ⁇ 3FD-PRP sample taken from nude mice.
  • FIG. 9B is an enlarged view of a region surrounded by a square in FIG. The scale bar indicates 200 ⁇ m.
  • FIG. 10 is a graph showing the calculation results of the bone formation rate in nude mice transplanted with each sample.
  • the graph shows the average value
  • the error bar shows the standard deviation.
  • “**” indicates that there is a significant difference when the risk rate is less than 1%
  • “*” indicates that there is a significant difference when the risk rate is less than 5%.
  • the number in a figure shows an average value.
  • n 3.
  • the group transplanted with the fresh PRP sample, ⁇ 1FD-PRP sample and ⁇ 3FD-PRP sample significantly promoted osteogenesis compared to the group transplanted with ⁇ -TCP sample. It was.
  • the osteogenesis rate of the group transplanted with the ⁇ 1FD-PRP sample was not significantly different from the osteogenesis rate of the group transplanted with the fresh PRP sample.
  • the osteogenesis rate of the group transplanted with the ⁇ 3FD-PRP sample was significantly higher than the osteogenesis rate of the group transplanted with the ⁇ 1FD-PRP sample.
  • the platelet-rich plasma can be stored for a long time without losing its function by freeze-drying.
  • platelets can be concentrated when reconstituted a freeze-dried form of platelet-rich plasma, thereby further promoting tissue regeneration.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Transplantation (AREA)
  • Virology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Materials Engineering (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne du plasma riche en plaquettes lyophilisé qui est sensiblement exempt de sucres exogènes de faible poids moléculaire, et un procédé de production d'un plasma riche en plaquettes lyophilisé comprenant une étape de congélation du plasma riche en plaquettes à -20 °C ou moins et une étape de lyophilisation du plasma riche en plaquettes congelé.
PCT/JP2016/068682 2015-06-23 2016-06-23 Plasma riche en plaquettes lyophilisé et son utilisation WO2016208675A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015-125916 2015-06-23
JP2015125916 2015-06-23

Publications (1)

Publication Number Publication Date
WO2016208675A1 true WO2016208675A1 (fr) 2016-12-29

Family

ID=57585191

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2016/068682 WO2016208675A1 (fr) 2015-06-23 2016-06-23 Plasma riche en plaquettes lyophilisé et son utilisation

Country Status (1)

Country Link
WO (1) WO2016208675A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111265548A (zh) * 2020-03-20 2020-06-12 山东省齐鲁细胞治疗工程技术有限公司 一种富血小板细胞因子血浆冻干粉的制备方法
US10843100B2 (en) 2010-10-29 2020-11-24 Velico Medical, Inc. Spray drier assembly for automated spray drying
WO2021117886A1 (fr) * 2019-12-12 2021-06-17 国立大学法人千葉大学 Préparation lyophilisée contenant des mégacaryocytes et des plaquettes
US11052045B2 (en) 2014-09-19 2021-07-06 Velico Medical, Inc. Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
JP7175055B1 (ja) * 2021-05-14 2022-11-18 セルソース株式会社 血液由来成長因子含有組成物及びその調製方法
US11841189B1 (en) 2022-09-15 2023-12-12 Velico Medical, Inc. Disposable for a spray drying system
US11975274B2 (en) 2022-09-15 2024-05-07 Velico Medical, Inc. Blood plasma product
US11998861B2 (en) 2022-09-15 2024-06-04 Velico Medical, Inc. Usability of a disposable for a spray drying plasma system

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08109136A (ja) * 1994-02-22 1996-04-30 Nippon Telegr & Teleph Corp <Ntt> 血球、幹細胞、および血小板の凍結乾燥生成物およびその製造方法
JP2001508807A (ja) * 1997-11-12 2001-07-03 バイオ−プロダクツ・アンド・バイオ−エンジニアリング・アクチエンゲゼルシヤフト 傷の治癒の促進のための医薬製品

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08109136A (ja) * 1994-02-22 1996-04-30 Nippon Telegr & Teleph Corp <Ntt> 血球、幹細胞、および血小板の凍結乾燥生成物およびその製造方法
JP2001508807A (ja) * 1997-11-12 2001-07-03 バイオ−プロダクツ・アンド・バイオ−エンジニアリング・アクチエンゲゼルシヤフト 傷の治癒の促進のための医薬製品

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
PIETRAMAGGIORI G. ET AL.: "Freeze-dried platelet- rich plasma shows beneficial healing properties in chronic wounds.", WOUND REPAIR REGEN., vol. 14, no. 5, 2006, pages 573 - 580, XP002687378 *
TSUNETAKA OGURA ET AL.: "Freeze Dry Gijutsu o Mochiita Konoshuku Takesshoban Kessho no Chosei", RESEARCH COUNCIL MEETING OF JAPAN SOCIETY OF PLASTIC AND RECONSTRUCTIVE SURGERY PROGRAM., vol. 22 nd, 2013, pages 123 *
TSUNETAKA OGURA ET AL.: "Freeze Dry Platelet- Rich Plasma ni yoru Sosho Chiyu Sokushin Koka no Kento", REGENERATIVE MEDICINE, vol. 14, February 2015 (2015-02-01), pages 269 *
YUYA NAKATANI ET AL.: "Freeze Dry Hozon shita Takesshoban Kessho (Platelet Rich Plasma) no Yuyosei no Kento", REGENERATIVE MEDICINE, vol. 14, February 2015 (2015-02-01), pages 195 *
YUYA NAKATANI ET AL.: "Platelet Rich Plasma (PRP) no Kokateki Hozonho no Kento", REGENERATIVE MEDICINE, vol. 13, 2014, pages 214 *

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10843100B2 (en) 2010-10-29 2020-11-24 Velico Medical, Inc. Spray drier assembly for automated spray drying
US11806431B2 (en) 2014-09-19 2023-11-07 Velico Medical, Inc. Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
US11052045B2 (en) 2014-09-19 2021-07-06 Velico Medical, Inc. Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
WO2021117886A1 (fr) * 2019-12-12 2021-06-17 国立大学法人千葉大学 Préparation lyophilisée contenant des mégacaryocytes et des plaquettes
JPWO2021117886A1 (ja) * 2019-12-12 2021-12-09 国立大学法人千葉大学 巨核球および血小板を含む凍結乾燥製剤
JP7058431B2 (ja) 2019-12-12 2022-04-22 国立大学法人千葉大学 巨核球および血小板を含む凍結乾燥製剤
CN111265548A (zh) * 2020-03-20 2020-06-12 山东省齐鲁细胞治疗工程技术有限公司 一种富血小板细胞因子血浆冻干粉的制备方法
JP7175055B1 (ja) * 2021-05-14 2022-11-18 セルソース株式会社 血液由来成長因子含有組成物及びその調製方法
US11841189B1 (en) 2022-09-15 2023-12-12 Velico Medical, Inc. Disposable for a spray drying system
US11913723B1 (en) 2022-09-15 2024-02-27 Velico Medical, Inc. Baffle plate used in a disposable for a spray drying system
US11913722B1 (en) 2022-09-15 2024-02-27 Velico Medical, Inc. Rapid spray drying system
US11975274B2 (en) 2022-09-15 2024-05-07 Velico Medical, Inc. Blood plasma product
US11998861B2 (en) 2022-09-15 2024-06-04 Velico Medical, Inc. Usability of a disposable for a spray drying plasma system

Similar Documents

Publication Publication Date Title
WO2016208675A1 (fr) Plasma riche en plaquettes lyophilisé et son utilisation
Thorn et al. Autologous fibrin glue with growth factors in reconstructive maxillofacial surgery
US9011929B2 (en) Composition for inducing tissue regeneration by activating platelet-rich plasma (PRP)
Liao et al. Combination of guided osteogenesis with autologous platelet-rich fibrin glue and mesenchymal stem cell for mandibular reconstruction
Gu et al. Polyphosphate-crosslinked collagen scaffolds for hemostasis and alveolar bone regeneration after tooth extraction
JP5406915B2 (ja) 生体適合性インプラント
AU2017311658B2 (en) Hemostatic compositions and methods of making thereof
Castro-Ceseña et al. Effect of starch on the mechanical and in vitro properties of collagen-hydroxyapatite sponges for applications in dentistry
JP2009538677A (ja) 組織再生のためのバイオメンブレン
WO2016112026A1 (fr) Produits hémostatiques
RU2506946C1 (ru) Технология лиофилизации обогащенной тромбоцитами плазмы с сохранением жизнеспособности факторов tgf pdgf vegf
US11744917B2 (en) Tissular formulation or adhesive obtained from a blood composition containing platelets, and method for the preparation of said formulation
US20180325961A1 (en) Acellular regenerative products and methods of their manufacture
US8691263B2 (en) Extracellular matrix comprising platelet concentrate and cryoprecipitate polymerized in situ
US20210060066A1 (en) Compositions and methods for platelet enriched fibrin constructs
JP2014030663A (ja) 徐放性組織再生材料
Altıntop et al. A novel hemostatic scaffold material and the importance of scaffold formation on ending hemorrhage: An experimental rat study.
TWI300806B (en) Medium and method for preserving platelets, red blood cells, and other non-nulceus cells and platelets-containing composition
Johnson et al. A-PRF: A Novel Member of the PRF Clan
Csönge et al. Thermal manipulation of human bone collagen membrane (SoftBone) and platelet-rich fibrin (PRF) membranes
RU2571288C1 (ru) Способ получения растворимого фибриногена ex vivo
RU2354406C1 (ru) Гемостатический материал
US20150140117A1 (en) Bioactivated bone substitute material
US20180325962A1 (en) Acellular regenerative products and methods of their manufacture
WO2022269035A1 (fr) Procédé de préparation et récipient pour un gel topique de cicatrisation de plaie

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16814444

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16814444

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP