Formulations involving solvent/detergent-treated plasma (s/d plasma) and uses thereof

A detergent, plasma technology, applied in the field of treatment of diseases such as musculoskeletal diseases, can solve the problems of inability to provide scaffolds, variable bacteria, ineffective non-lipid enveloped viruses, etc.

Active Publication Date: 2015-06-10
BONE THRAPEUTICS SA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, high molecular weight HA has the disadvantage of not providing a fully satisfactory scaffold due to gelation

Method used

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  • Formulations involving solvent/detergent-treated plasma (s/d plasma) and uses thereof
  • Formulations involving solvent/detergent-treated plasma (s/d plasma) and uses thereof
  • Formulations involving solvent/detergent-treated plasma (s/d plasma) and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0156] Example 1: Comparison between Human Solvent / Detergent Treated Plasma (S / D Plasma) and Human Fresh Frozen Plasma (FFP)

[0157] Compositional Characteristics of Exemplary Formulations

[0158] S / D plasma (i.e. obtained from Octapharma AG (Lachen, Switzerland) ) provides a comparison between the compositional characteristics of S / D plasma and human fresh frozen plasma (FFP), as shown in Table 1. Based on this information, the products have largely comparable plasma protein compositions; S / D plasma may show significantly lower levels of plasmin inhibitors.

[0159] Table 1: Based on S / D plasma of product topic material (specifically ) and the composition characteristics of fresh frozen plasma (FFP)

[0160]

[0161] Comments on S / D plasma (specifically ) and the composition of fresh frozen plasma, Svae et al. concluded in 2007 that the manufacturing method (including S / D treatment) did not cause a critical decrease in the activity of coagulation factors and nat...

Embodiment 2

[0178] Example 2: Human solvent / detergent (S / D) treated plasma ( ) and hyaluronic acid (HA) for gel formation

[0179] clot / gel formation with HA

[0180] Human S / D plasma (specifically ) performance. The synovial fluid is brought into contact with a formulation according to one embodiment of the invention in a ratio of 1:1 (v / v), said formulation comprising Hyaluronic acid (10mg / ml sodium hyaluronate, 1.8-2.10 6 Molecular weight of Da, provided by Contipro, Czech Republic) and CaCl 2 . Tried three kinds of CaCl 2 Concentrations, i.e. 0, 2 and 4mg / ml CaCl 2 . Gel formation was assessed visually after different time points (20-30 min, 1 h, 2 h) using a timer. Viscosity was evaluated by measuring the time required for the solution to reach a defined mark on the vessel wall when the reaction tube was turned upside down. The test was performed twice on synovial fluid from 2 arthritic patients.

[0181] Incubate with synovial fluid containing 4mg / ml CaCl 2 The prep...

Embodiment 3

[0205] Example 3: Human S / D plasma (such as ) and the gel formation of the cell composition

[0206] and contain Ca 2+ Clot / Gel Formation of Cell Culture Media

[0207] For several cell-free, but containing human S / D plasma (specifically ), conventional medium (containing CaCl 2 ) and human serum preparations were tested for clot formation. Different conditions were tested to verify the Clot formation at 37°C under the following conditions: different concentrations, for example, 5%, (v / v) 7.5% v / v or 10% v / v; different conventional media, for example, DMEM, MEM, PBS or PBS+CaCl 2 and the absence or presence of 5 or 10% (v / v) serum. When combined in the absence of cells Regular medium (which contains CaCl 2 ) and serum, clot formation was visually observed.

[0208] It can be concluded that the presence of serum as well as calcium in the medium appears to be necessary for clot formation in the absence of cells.

[0209] and clot / gel formation of cellular compo...

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Abstract

The invention concerns pharmaceutical formulations comprising solvent/detergent (S/D)-treated plasma and a glycosaminoglycan such as hyaluronic acid, and their use for treating diseases, particularly musculoskeletal diseases.

Description

technical field [0001] The present invention relates to pharmaceutical formulations and their use for the treatment of diseases such as musculoskeletal diseases and more particularly bone or joint diseases. Background technique [0002] Musculoskeletal diseases or disorders can affect bones, muscles, joints, cartilage, tendons, ligaments, and other connective tissues that support and hold tissues and organs together. These disorders can develop over time, or can result, for example, from overuse of the musculoskeletal system or from trauma. Musculoskeletal disorders can be difficult to diagnose and / or treat due to the close relationship of the musculoskeletal system to other internal systems. [0003] A possible and promising approach for the treatment of musculoskeletal diseases, especially bone and joint diseases, is the transplantation of mesenchymal stem cells (MSCs) capable of undergoing osteogenic or chondrogenic differentiation or directed to Cells of the osteocytic...

Claims

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Application Information

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IPC IPC(8): A61K35/16A61K45/00A61K9/00C08B5/00A61P19/08A61P19/02A61K35/28A61K35/32C08B5/08A61K31/728A61K31/726A61K31/4168
CPCA61K31/728A61K35/28A61K35/32A61K2300/00C08L5/00C08L5/08A61K45/06A61K31/726A61K31/4168A61K35/16A61P19/00A61P19/02A61P19/08A61P21/00A61K38/18A61K38/1825A61K38/1841A61K38/1858A61K38/1875A61K38/2053A61K38/29A61K47/46
Inventor E·巴斯蒂安奈利V·阿拉巴拉尼
Owner BONE THRAPEUTICS SA
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