EP3989990A1 - Bacterie de la famille des christensenellacees et composition en contenant pour la prevention et/ou le traitement d'une perte de masse musculaire pathologique ou d'une maladie caracterisee par une perte de masse musculaire pathologique - Google Patents
Bacterie de la famille des christensenellacees et composition en contenant pour la prevention et/ou le traitement d'une perte de masse musculaire pathologique ou d'une maladie caracterisee par une perte de masse musculaire pathologiqueInfo
- Publication number
- EP3989990A1 EP3989990A1 EP20739277.0A EP20739277A EP3989990A1 EP 3989990 A1 EP3989990 A1 EP 3989990A1 EP 20739277 A EP20739277 A EP 20739277A EP 3989990 A1 EP3989990 A1 EP 3989990A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bacterium
- loss
- use according
- composition
- bacteria
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- 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
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
-
- 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
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
-
- 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
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/06—Anabolic agents
-
- 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
- A61K2035/11—Medicinal preparations comprising living procariotic cells
- A61K2035/115—Probiotics
Definitions
- the invention relates to the preservation of muscle mass.
- the invention relates to bacteria specific to the intestinal microbiota and to compositions containing them for the prevention and / or treatment of pathological muscle loss or of a disease characterized by pathological muscle loss.
- pathological muscle mass is well known to those skilled in the art and refers to muscle atrophy, a decrease in muscle volume (Gordon et al. Therapeutic approaches for muscle wasting disorders. Pharmacol Ther. 2007 Mar; 113 (3): 461-87).
- This muscle loss generally involves the skeletal striated muscles, which are muscles under voluntary control.
- Several pathologies are characterized by a loss of muscle mass, in particular muscular atrophy, pre-sarcopenia, sarcopenia, rhabdomyolysis, cachexia.
- Amyotrophy is a decrease in the volume of the skeletal and cardiac striated muscles, that is to say that the number of fibers making up these muscles (long cells) decreases.
- Sarcopenia is a syndrome characterized by a decrease in muscles due to age and which can lead to deterioration in muscle strength and physical performance.
- Rhabdomyolysis is a disease in which skeletal muscle cells quickly break down and release their contents into the bloodstream. Some of these breakdown products of damaged muscle cells are harmful to the kidneys and can lead to kidney failure in particular. The disease is characterized by several symptoms such as muscle pain, vomiting and confusion, and in some cases it can be life-threatening. Some animals can be affected, especially horses. Cachexia is a profound weakening of the organism which is characterized by weight loss, fatigue and muscular atrophy in particular, linked to very significant undernutrition.
- Muscle atrophy can be caused in particular by the synthesis of norleucine in the body.
- Other markers of muscle wasting are known as albumin, pre-albumin, C reactive protein, and myoglobin.
- Norleucine is a non-proteinogenic amino acid which, when present, takes the place of another amino acid, methionine, during protein synthesis. This replacement of methionine by norleucine is toxic to the cells and in particular it prevents the renewal of muscle cells, decreases the growth of muscle fibers and reduces muscle development (Bogosian et al. Biosynthesis and Incorporation Into Protein of Norleucine by Escherichia Coli , J Biol Chem 1989 Jan 5; 264 (l): 531-9. Norleucine particularly affects organs where protein replacement is important such as muscles. Thus, muscles are subject to toxicity from low dose norleucine. For example, Jeffery Escobar et al. 2010 demonstrated that administration of leucine in piglets has a positive effect on skeletal muscle protein synthesis and that norleucine has no positive effect on protein synthesis in muscle It also shows that the chemical structure of leucine gives it these properties.
- Norleucine can be synthesized by bacteria as side products of the branched-chain amino acid synthesis pathway from pyruvate and alpha-ketobutyrate.
- the toxicity of norleucine is very little studied and no treatment for pathological muscle loss or a disease characterized by pathological muscle loss is based on a reduction in the toxicity of norleucine despite the involvement of this amino acid in ubiquitous metabolic pathways.
- Albumin is a soluble protein which is assayed to check the amount of protein in the blood. A low concentration of albumin is a marker of undernutrition which is accompanied by significant loss of muscle.
- the C reactive protein is a protein which shows the inflammatory state of the patient which is observed during muscle loss due to cachexia in particular.
- a high concentration of C reactive protein is a marker of cachexia which is accompanied by significant loss of muscle.
- Myoglobin is a protein capable of transporting oxygen to the muscles, therefore essential for the work and development of muscles.
- a high concentration of plasma myoglobin is a marker of muscle damage or rhabdomyolysis in multiple trauma, infectious diseases, muscular dystrophy, myopathy.
- pathological muscle loss or diseases characterized by pathological muscle loss are not effective. Indeed, these consist essentially of physical exercises during sessions repeated several times a week, an optimal protein intake to stimulate protein synthesis, the installation of an infusion containing a saline solution, an alkalization of the urine, a dialysis , surgery on the injured region which does not allow a satisfactory result to be obtained.
- treatments are often heavy, such as the treatment of rhabdomyolysis which consists of heavy intravenous infusions, and which may require dialysis or hemofiltration in more severe cases.
- the bacteria of the Christensenellaceae family when they are administered to humans or animals, are capable of acting on the markers of the loss of pathological muscle mass to prevent or treat this disease or diseases characterized by loss of muscle mass such as muscular atrophy, sarcopenia, pre-sarcopenia, rhabdomyolysis, cachexia.
- the subject of the invention is a bacterium of the Christensenellaceae family, for its use in the prevention and / or treatment of muscle atrophy in humans or animals, in particular.
- a bacterium when it is administered to a human being or an animal exhibiting a pathological loss of muscle mass or a disease characterized by a loss of muscle mass, is capable of acting on the molecules produced in excess during this.
- pathological condition such as in particular norleucine, and also optionally against albumin and / or pre-albumin and / or protein C and / or myoglobin allowing an increase in protein synthesis and production of muscle cells to recover the lost muscle mass.
- the bacteria for their use according to the invention are administered in compositions.
- a subject of the invention is also the compositions comprising at least one bacterium of the Christensenellaceae family, for its use in the prevention and / or treatment of a pathological loss of muscle mass or of a disease characterized by a loss. muscle mass in humans or animals.
- loss of pathological muscle mass or “loss of muscle mass” or “pathological muscle loss” within the meaning of the invention is meant an abnormal, pathological decrease in muscle mass due to a decrease in protein synthesis, in particular of skeletal muscle mass.
- the term “disease characterized by a loss of pathological muscle mass” or “disease characterized by a loss of muscle mass” means a disease of which one of the symptoms is a loss of muscle mass. It could be especially muscular atrophy, sarcopenia, pre-sarcopenia, rhabdomyolysis or cachexia.
- the term “marker” of a disease means a molecule or a substance, the dosage of which makes it possible to follow the course of said disease.
- the subject of the invention is the use for preventing and / or treating a pathological loss of muscle mass or a disease characterized by a loss of muscle mass, in humans or animals, of at least one bacterium of the family of Christensenellaceae.
- the invention therefore relates to a bacterium of the Christensenellaceae family for its use in the prevention and / or treatment in humans or animals of a pathological loss of muscle mass or of a disease characterized by a loss of muscle mass.
- muscle mass in particular chosen from amyotrophy, sarcopenia, pre-sarcopenia, rhabdomyolysis and cachexia, in particular in people or animals with pathological loss of muscle mass or a disease characterized by pathological loss of muscle mass with a synthesis of at least norleucine and / or of at least one marker chosen from: albumin and / or pre-albumin and / or C reactive protein and / or myoglobin.
- bacteria of the Christensenellaceae family when administered to a human being or an animal exhibiting loss of muscle mass or a disease characterized by loss of muscle mass, are capable of acting on molecules produced in excess during this pathological state, in particular on the production of norleucine and / or at least one marker chosen from: albumin and / or pre-albumin and / or C reactive protein and / or myoglobin.
- a pathological loss of muscle mass in particular in diseases characterized by a loss of muscle mass which exhibit a synthesis of norleucine, and / or a synthesis of at least one marker chosen from: albumin and / or pre-albumin and / or C-reactive protein and / or myoglobin, their decrease is a sign of increased protein synthesis and increased production of muscle cells.
- the bacteria useful according to the invention are administered to humans or animals in an amount effective for an action on at least one of these markers of a loss of pathological muscle mass, that is to say for decrease the production of at least one of these markers in the body.
- the bacteria or bacteria are administered at a dose of 10 9 to 10 12 colony forming units (CFU) per day, regardless of the weight of the person or of the animal.
- CFU colony forming units
- it is a single dose, that is to say administered all at once or a dose before each meal, ie three times a day.
- the bacteria useful according to the invention are bacteria of the Christensenellaceae family, preferably of the genus Christensenella. It may in particular be Christensenella massiliensis, Christensenella timonensis and / or Christensenella minuta. According to a particularly suitable variant, it is Christensenella minuta.
- the bacteria which are useful according to the invention are preferably administered to humans or animals in a composition.
- a subject of the invention is also a composition comprising at least one bacterium of the Christensenellaceae family for its use in the prevention and / or treatment of a pathological loss of muscle mass or of a disease characterized by a loss of muscle mass.
- muscle mass in humans or animals, in particular in people or animals exhibiting a synthesis of norleucine and / or at least one marker chosen from: albumin and / or pre-albumin and / or protein C and / or myoglobin.
- the bacteria are present in an effective amount in the composition allowing an effect on the loss of muscle mass from which the persons or animals treated are affected.
- the composition useful according to the invention comprises 10 6 to 10 12 colony-forming units (CFU) of bacteria of the Christensenellaceae family per daily dose of composition to be administered.
- CFU colony-forming units
- this corresponds to a daily dose of bacteria to be administered, whatever the weight of the person or the animal.
- this daily dose is administered all at once.
- composition useful according to the invention can be in liquid form. It may in particular comprise bacteria of the Christensenellaceae family and a culture medium for said bacteria which makes it possible to conserve them, such as, for example, preferably Columbia anaerobic agar medium enriched with sheep blood, or an equivalent medium not containing a product derived from animal origin.
- compositions When the compositions are in liquid form, they are preferably frozen, maintained at -20 ° C. in an airtight sachet.
- the composition useful according to the invention can be provided in solid form.
- the bacteria can be present in lyophilized form, and the compositions can also comprise excipients such as, for example, microcrystalline cellulose, lactose, sucrose, fructose, levulose, starches, stachyose, raffinose, l 'amylum, calcium lactate, magnesium sulfate, sodium citrate, calcium stearate, polyvinylpyrrolidone, maltodextrin, galactooligosaccharides, fructooligosaccharides, pectins, beta-glucans, lactoglobulins, isomaltooligosaccharides, polydextroses, sorbitol and / or glycerol.
- excipients such as, for example, microcrystalline cellulose, lactose, sucrose, fructose, levulose, starches, stachyose, raffinose, l
- compositions useful according to the invention can be in particular in the form of powder, microencapsulated powder, gelatin capsule, capsule, tablet, lozenge, granules, emulsion, suspension or suppository. According to a particularly suitable embodiment, they can be in a gastro-resistant form, such as a coated tablet containing microencapsulated bacteria.
- compositions When the compositions are in solid form, they are preferably packaged in capsules or in a coating hermetic to light and to oxygen maintained at an ambient temperature of between 15 ° C and 40 ° C and a humidity of between 3% and 70%.
- the bacteria can be used alive or inactivated, for example by heat, exposure to an appropriate pH, gamma rays or high pressure.
- At least one part consists of bacteria that are alive, in particular at least 50% (by number), even more preferably at least 90% (by number).
- the bacteria present in the composition useful according to the invention are at least 50% of living bacteria (by number), preferably for at least 90% of living bacteria (by number), even more preferably all alive.
- the bacteria useful according to the invention can be administered orally, topically, respiratory (inhalation) or rectally.
- compositions useful according to the invention in addition to the bacteria useful according to the invention can comprise other compounds, such as:
- At least one bacterium producing lactic acid which makes it possible to create an anaerobic environment favorable to Christensenellaceae, such as at least one bacterium chosen from bacteria of the genus Lactobacillus spp., Bifidobacterium spp., Streptococcus spp. and / or at least one other organism promoting the anaerobic conditions necessary for the survival of Christensenellaceae such as at least one yeast chosen from Saccharomyces spp. or microorganisms of the Methanobacteriaceae family and / or
- At least one bacterium associated with the ecosystem of Christensenellaceae because they facilitate their survival in the intestine such as at least one bacterium chosen from bacteria of the phylum Firmicutes, Bacteroidetes, Actinobacteria, Tenericutes, and Verrucomicrobia, and / or
- At least one bacterium chosen from bacteria of the order Clostridales, Verrucomicrobiales, Aeromonadales, Alteromonadales, ML615J-28, RF32, YS2, of the Clostridiaceae family, Lachnospiraceae, Erysipelotrichaceae, Ruminococcaceae, Bacteroidaceae , Enterococcaceae, Rikenéllaceae, Dehalobacteriaceae, Veillonellaceae and / or
- Faecalibacterium chosen from bacteria of the genus Faecalibacterium, Akkermansia, Eubacterium, Turicibacter and Oscillospira such as for example Faecalibacterium prausnitzii, Akkermansia muciniphila, Eubacterium halii, Turicibacter sanguinis, Oscillospiraguilliermondii, and / or
- At least one prebiotic such as for example at least one prebiotic chosen from galactooligosaccharides, fructooligosaccharides, inulins, arabinoxylans, beta-glucans, lactoglobulins and / or beta-caseins, and / or
- At least one polyphenol such as for example at least one polyphenol chosen from quercetin, kaempferol, resveratrol, flavones (such as luteolin), flavan-3-ols (such as catechins), flavanones (such as narinenin) ), isoflavones, anthocyanidins, proanthocyanidins, and / or
- a pathological loss of muscle mass and / or of a disease associated with a loss of muscle mass such as, for example, autophagy inhibitors, in particular in the case of cachexia, nusinersen, flunarizine, riluzole, in particular in the case of muscular atrophy, vitamin D, sevelamer, polystyrene sulfonate, calcium, calcimetics (in particular cinacalcet), darbopoietin , erythropoietin, furosemide, hydrochlorothiazide especially in the case of rhabdomyolysis
- autophagy inhibitors in particular in the case of cachexia, nusinersen, flunarizine, riluzole, in particular in the case of muscular atrophy, vitamin D, sevelamer, polystyrene sulfonate, calcium, calcimetics (in particular cinacalcet), darbopoietin , erythropoiet
- the Christensenella minuta bacteria can be cultured according to the operating protocol described below.
- the Christensenella massiliensis bacteria can be cultured according to the operating protocol described below.
- the meat filtrate is prepared as follows.
- Bacteria should be grown in anaerobic condition at 37 ° C.
- the Christensenella timonensis bacteria can be cultured according to the same operating protocol as that described in Example 2 for Christensenella massiliensis.
- Example 4 Useful composition according to the invention in liquid form
- composition useful according to the invention in liquid form is a composition comprising Christensenella minuta 10 9 CFU / mL in the anaerobic RCM culture medium described above, modified to contain no product of animal origin and enriched in 5% glycerol. .
- Example 4 The composition of Example 4 is obtained from an RCB (“research cell bank”) prepared on the basis of Christensenella minuta 10 10 CFU / mL then stored frozen at -20 ° C in an airtight bag. with oxygen.
- RCB search cell bank
- the frozen composition must be warmed to room temperature until it returns to liquid form before use.
- Example 5 Composition useful according to the invention in solid form
- composition useful according to the invention in lyophilized form can be obtained by lyophilization of the composition of Example 4 in the frozen state.
- Norleucine is a non-proteinogenic amino acid which replaces methionine during protein synthesis. This replacement is toxic: it has been shown to cause a decrease in the stability of cytochrome P450 (Cirino, PC, Tang, Y., Takahashi, K., Tirrell, DA & Arnold, FH Global incorporation of norleucine in place of methionine in cytochrome P450 BM-3 heme domain increases peroxygenase activity. Biotechnol. Bioeng. (2003). doi: 10.1002 / bit.10718) and a lack of stimulation of muscle synthesis in pigs (Escobar, J. et al. Leucine and alpha-ketoisocaproic acid, but not norleucine, stimulate skeletal muscle protein synthesis in neonatal pigs. J. Nutr. 140, 1418-24 (2010)).
- This non-proteinogenic amino acid can be synthesized by different bacterial pathways including the branched chain amino acid synthesis pathway from pyruvate and alpha-ketobutyrate where norleucine is a by-product.
- the operating protocol of the study is described below.
- the basic nutrient medium was prepared from 2g / L of soybean tryptone broth, 2g / L of yeast extract, 0.1g / L of NaCl, 0.04g / L of K2 HP04, 0.01g / L of MgS0 3 .7 H 2 0, 0.01g / L of CaCl 2 .6H 2 0, 2g / L NaHCOs, 0.5g / L of L-cystine HCl, 2m L / L of tween 80, 10pL / L of vitamin Kl, 0.05g / L of heme, 0.05g / L of bile salts, 4ml / L of resazarin (pH7)
- the 20mL biofermenters contained 18mL of basic nutrient medium autoclaved (121 ° C for 15 minutes) and poured aseptically into sterile biofermenters. This system was left to stand overnight with oxygen-free nitrogen bubbling through the medium at a rate of 2 mL / min.
- the pH was maintained between 6.7 and 6.9 using HCl or NaOH (0.5M).
- the temperature of each biofermenter was controlled at 37 ° C and the contents of the vessel homogenized with a magnetic mixer
- predigested proteins (0.35g) was added to the containers before inoculation with 2mL of fecal inocula at T0.
- the predigested proteins were obtained according to the gastrointestinal digestion protocol adapted from that of Vorsantvoort et al (2005).
- the mixture was mixed and filtered through a 5-kDa cutoff filter to remove macromolecules.
- the metabolites were detected by capillary electrophoresis and time-of-flight mass spectrometry (CE-TOFMS) analyzes.
- Relative peak area (peak area of a metabolite) / (peak area of internal standard x amount of sample).
- the library was then sequenced using 2 x 150 bp paired-end sequencing on an Illumina HiSeq platform.
- bacteria of the Christensenellaceae family are capable of acting by reducing the production of markers of a pathological loss of muscle mass or of a disease characterized by a loss of pathological muscle mass, in particular of norleucine. They can therefore be used to prevent and / or treat pathological loss of muscle mass or diseases characterized by loss of muscle mass.
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- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
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- Epidemiology (AREA)
- Molecular Biology (AREA)
- Physical Education & Sports Medicine (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Orthopedic Medicine & Surgery (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1906843A FR3097740B1 (fr) | 2019-06-25 | 2019-06-25 | Bactérie de la famille des Christensenellacées et composition en contenant pour la prévention et/ou le traitement d’une perte de masse musculaire pathologique ou d’une maladie caractérisée par une perte de masse musculaire pathologique |
PCT/EP2020/067892 WO2020260493A1 (fr) | 2019-06-25 | 2020-06-25 | Bacterie de la famille des christensenellacees et composition en contenant pour la prevention et/ou le traitement d'une perte de masse musculaire pathologique ou d'une maladie caracterisee par une perte de masse musculaire pathologique |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3989990A1 true EP3989990A1 (fr) | 2022-05-04 |
Family
ID=68138453
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20739277.0A Pending EP3989990A1 (fr) | 2019-06-25 | 2020-06-25 | Bacterie de la famille des christensenellacees et composition en contenant pour la prevention et/ou le traitement d'une perte de masse musculaire pathologique ou d'une maladie caracterisee par une perte de masse musculaire pathologique |
Country Status (4)
Country | Link |
---|---|
US (1) | US20230131906A1 (fr) |
EP (1) | EP3989990A1 (fr) |
FR (1) | FR3097740B1 (fr) |
WO (1) | WO2020260493A1 (fr) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2023069605A1 (fr) * | 2021-10-20 | 2023-04-27 | Arizona Board Of Regents On Behalf Of Arizona State University | Systèmes, procédés et appareils de mise en œuvre d'une plateforme d'analyse de santé, de nutrition et de composition corporelle en nuage |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
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FR3063646B1 (fr) * | 2017-03-10 | 2021-07-30 | International Nutrition Res Company | Bacteries specifiques pour leur utilisation comme medicament en particulier pour lutter contre le surpoids, l'obesite, les maladies cardiometaboliques et les maladies inflammatoires de l'intestin |
-
2019
- 2019-06-25 FR FR1906843A patent/FR3097740B1/fr active Active
-
2020
- 2020-06-25 WO PCT/EP2020/067892 patent/WO2020260493A1/fr unknown
- 2020-06-25 EP EP20739277.0A patent/EP3989990A1/fr active Pending
- 2020-06-25 US US17/915,600 patent/US20230131906A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
WO2020260493A1 (fr) | 2020-12-30 |
FR3097740A1 (fr) | 2021-01-01 |
US20230131906A1 (en) | 2023-04-27 |
FR3097740B1 (fr) | 2021-06-25 |
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