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Supplemented matrices for the repair of bone fractures

A matrix and mineral technology, applied in medical science, prosthesis, etc., can solve problems such as healing fractures that are not described

Inactive Publication Date: 2008-01-02
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, WO 03 / 052091 does not describe a matrix suitable for healing fractures, especially for the repair of severe fractures, such as those at risk of becoming delayed union or nonunion

Method used

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  • Supplemented matrices for the repair of bone fractures
  • Supplemented matrices for the repair of bone fractures
  • Supplemented matrices for the repair of bone fractures

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0118] Example 1: PTH 1-34 And TGpl PTH 1-34 Biological activity

[0119] Full-length PTH 1-84 PTH with similar activity 1-34 Peptides and proteins of this length can be synthesized by standard solid-state peptide synthesis methods.

[0120] All peptides were synthesized on solid resin using an automated peptide synthesizer using standard 9-fluorenylmethoxycarbonyl chemistry. The peptides were purified by cl 8 chromatography and analyzed by HPLC with reverse phase chromatography to determine purity and mass spectrometry (MALDI) analysis to identify the molecular weight of each product. Using this method, PTH was synthesized 1-34 And TG-pl-PTH 1-34 NQEQVPLYKNRSVSEIQLMHNLGKHLNSMERVEWL-RKKLQDVHNF (SEQ ID NO.19) and TG PTH 1-34 NQEQVPLSVSEIQLMHNLGKHLNSMERVEWLRKKLQDVHNF (SEQ ID NO. 20). TGplPTH 1-34 And TG PTH 1-34 With PTH 1-34 The difference is that it additionally contains a factor XIIIa substrate domain, which is linked to PTH through the plasmin-degradable pl sequence YKNR (SEQ ID...

Embodiment 2

[0122] Example 2: Release of PTH from the fibrin matrix

[0123] Fibrin Matrix by TISSEEL  Kit (Baxter AG, CH-8604Volketswil / ZH) fibrin precursor component preparation. The composition is listed in Table 2. At 0,1μg / ml PTH 1-34 Or TGPTH 1-34 In the presence of thrombin, add thrombin and mix to form a uniform concentration. TGPTH 1-34 It only has a transglutaminase sequence at the amino terminus and no degradation sites. Therefore, TGPTH 1-34 It can only be released by the degradation of the fibrin matrix itself. The peptide was synthesized as described in Example 1.

[0124] For the first release assay, 50 μl fibrin matrix with 0.1 mg PTH or TGPTH / ml fibrin matrix was incubated in 10 ml buffer at 37°C. Therefore, for total release, the concentration of PTH or TGPTH in the buffer will be 0.5 μg PTH or TGPTH / ml fibrin matrix. In order to compare the stability of PTH or TGPTH during the measurement, the PTH or TGPTH sample was directly diluted in buffer to a concentration of 0.5 μg ...

Embodiment 3

[0128] Example 3: Sheep tibia defect model

[0129] From TISSEEL  Kit (Baxter AG, CH-8604 Volketswil / ZH) began to form a fibrin matrix, resulting in 4ml fibrin matrix. TISSEEL  It is produced from combined human-sourced plasma and the content of the active ingredient can vary from batch to batch within a predetermined range.

[0130] Matrix: Three separate syringes were used to prepare the matrix, a two-way syringe containing fibrin precursor solution and PTH fusion peptide (syringes 1 and 2), and two one-way syringes containing particles (syringes 3 and 4). Table 2 lists the final composition used.

[0131] Table 2: Including TISSEEL  And the final composition of the active ingredient

[0132] Ingredients

Dosage / 2ml gel

Syringe 1 (1mL)

Active components:

PTH 1-34 Fusion peptide (TGplPTH 1-34 )

0.4-10mg

Coagulant

Fibrinogen (human)

Other proteins

Aprotinin (bovine)

Human albumin

Buffer component

Nicotinamide

L-histidi...

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Abstract

Supplemented matrices comprising a PTH releasably incorporated therein, optionally containing a granular material, are described herein. The PTH is incorporated either through covalent linkage to the matrix or through non-covalent interaction with the matrix and / or the granules. These supplemented matrices decrease the time of healing compared to autograft and or trigger healing of bone fractures which otherwise would not heal. The matrices are biocompatible and biodegradable and can be formed in vitro or in vivo, at the time of implantation. The PTH may be a part of a fusion peptide. PTH can be incorporated into the matrices with full retention of its bio-activit y. PTH can be releasably incorporated, using techniques that provide control over how and when and to what degree the PTH is released using the matrix as a controlled release vehicle to heal bone fractures.

Description

Invention field [0001] This application relates to supplemented matrices and their use for repairing and healing fractures. Background of the invention [0002] In Europe and the United States, it is estimated that 5 to 6 million people suffer fractures each year due to trauma, sports or activity-related injuries, or osteoporosis. Most of these injuries can be treated with manual reduction or external fixation (for example, models). However, about 20 to 25% of fractures require hospitalization, usually using open surgical procedures. [0003] A fracture is defined as a discontinuity in the cortical bone structure, usually caused by excessive mechanical force. A complete fracture is defined as a discontinuity or break in the entire bone structure, resulting in two or more separate bone segments. For injuries classified as fractures, the bone segments need not be separated. In some cases, the periosteum holds the bone segments in their original anatomical position. In other cases, ...

Claims

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Application Information

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IPC IPC(8): A61L27/22A61L27/12
Inventor J·谢恩塞J·沃森I·阿里吉
Owner BAXTER INT INC
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