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Extracorporeal device and matrix for removing fibrinolytic proteins from biological fluids, methods and uses thereof

A device, derivative technology, applied in the field of blood coagulation and transfusion medicine, can solve the problem that the product cannot support clot formation, and cannot be used to treat bleeding and hemostasis disorders

Pending Publication Date: 2020-10-13
PLAS FREE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the lack of fibrinogen, the resulting product cannot support clot formation and therefore cannot be used in the treatment of bleeding and hemostatic conditions

Method used

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  • Extracorporeal device and matrix for removing fibrinolytic proteins from biological fluids, methods and uses thereof
  • Extracorporeal device and matrix for removing fibrinolytic proteins from biological fluids, methods and uses thereof
  • Extracorporeal device and matrix for removing fibrinolytic proteins from biological fluids, methods and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0652] Synthetic resin

Embodiment 11

[0653] Example 1.1 - Synthesis of Conjugate 1

[0654]

[0655] Resin production and filter packaging - scaling up

[0656] The procedure was performed according to the NHS Activated Sepharose Fast Flow (GE Healthcare Cat. No. 17-0906-02) product instructions.

[0657] The process begins with receiving a new batch of pure unprocessed beads and proper documentation load .

[0658] The resin volume for this protocol was 112 mL of drained resin (8 x 14 mL) in 8 x 50 mL tubes (initially 70% resin slurry; 14 mL drained resin per tube). This protocol yielded a batch of three complete ClearPlasma filters. Preparation, coupling and post-coupling washes are performed as cleanly as possible. The endotoxin washing and packaging stages are carried out in a clean environment.

[0659] labware used

[0660] 0.2 μm filter (e.g. Steritop), 3x1L bottles (1mM HCl; 0.1M Tris-HCl, pH 8.5; 0.1M acetate buffer, 0.5M NaCl, pH 4.5), 2x0.5 L bottles (coupling buffer; 4M Urea), 4x1...

Embodiment 12

[0718] Example 1.2 - Synthesis of Conjugate 2

[0719]

[0720] The reaction to prepare conjugate 2 was in figure 1 shown schematically.

[0721] More specifically, the following procedure is employed:

[0722] 1. Using a shaker, wash a 4.2 ml amount of Sepharose 4B200 (Sigma Aldrich) with acetone through a filter glass funnel. The agarose gel is considered to contain 1 ml of reactive functional groups, so 4.2 ml contains 4.2 mmol.

[0723]2. Add succinic anhydride (0.42, 4 mmol) to the beads in CH 2 Cl 2 (3ml) followed by addition of pyridine (0.339ml). The mixture was shaken overnight.

[0724] 3. Beads are small pieces and washed with acetone.

[0725] 4. Suspend the beads in CH 2 Cl 2中 , and N-hydroxysuccinimide NHS (0.483 g) was added followed by EDC (0.8 g). The mixture was shaken overnight, then filtered.

[0726] 5. Suspend the product in DMF (3ml), add N,N-diisopropylethylamine (0.54g) and 4-(aminomethyl)-cyclohexanecarboxylic acid (0.66g). The mixtur...

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Abstract

The presently disclosed subject-matter provides specific compositions, conjugates, device, kits and systems for depleting fibrinolytic agents from biological fluids. The presently disclosed subject-matter further relates to the resulting biological fluid products that are devoid in fibrinolytic activity, therapeutic methods and uses thereof. The conjugates comprise a particle, at least one linkerand at least one amino acid, derivative thereof or analog thereof being at least one of 4-(aminomethyl)-cyclo-hexane-carboxylic acid (tranexamic acid), epsilon-amino caproic acid, lysine, cyclohexanecarboxylic acid and 4-methyl-cyclohexanecarboxylic acid. A plurality of different conjugates (e.g. differing in partcile size or type of linker) can be used.

Description

technical field [0001] The invention belongs to the field of coagulation and blood transfusion medicine. More specifically, the present invention provides specific devices and matrices for depleting fibrinolytic activity from biological fluids, the resulting biological fluid products devoid of fibrinolytic activity, methods and uses thereof. Background technique [0002] Listed below are references considered to be background art to the subject matter of the present disclosure. [0003] Selighson U et al., Classification, Clinical Manifestations & Evaluation of Disorders of Hemostasis. In: Williams Hematology, 8th Ed., 2010, pp. 2322-2330. [0004] Abdel-Wahab OI et al., Effect of fresh-frozen plasma transfusion on prothrombin time and bleeding in patients with mild coagulation abnormalities. Transfusion 2006;46:1279-1285. [0005] Holland LL et al. Toward rational fresh frozen plasma transfusion: The effect of plasma transfusion on coagulation test results. Am J Clin Path...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M1/34A61M1/02A61K38/55
CPCA61M1/0281A61M1/3486A61K35/14C12Y304/21068A61K38/48A61P7/04A61P7/08A61K35/16A61M2202/0449A61M2205/8206G01N33/86C07C217/06C07C233/47
Inventor A·A·海加兹Z·德瓦希
Owner PLAS FREE LTD
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