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Compositions and methods for treating the vertebral column

A composition and drug technology, applied in the direction of drug combination, application, tissue regeneration, etc., can solve the problems of preventive treatment and prevention of secondary VCF unmet clinical needs, increasing morbidity, etc.

Inactive Publication Date: 2010-09-01
BIOMIMETIC THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Now that the use of minimally invasive surgical techniques for the treatment of vertebral compression fractures increases morbidity and adjacent vertebrae are susceptible to secondary compression fractures, there is an unmet clinical need for prophylactic treatment and prevention of secondary VCF

Method used

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  • Compositions and methods for treating the vertebral column
  • Compositions and methods for treating the vertebral column
  • Compositions and methods for treating the vertebral column

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0108] The present invention provides a preparation method of a composition for promoting bone formation in a vertebral body and preventing or reducing the possibility of vertebral body compression fractures (including secondary vertebral fractures). In one embodiment, the method for preparing said composition comprises: providing a PDGF-containing solution, providing a biocompatible matrix and disposing said solution in said biocompatible matrix. Suitable PDGF solutions and biocompatible matrices for the combination correspond to those PDGF solutions and biocompatible matrices described above.

[0109] In some embodiments, the PDGF solution can be disposed in the biocompatible matrix by wetting the biocompatible matrix in the PDGF solution. In another embodiment, the PDGF solution can be disposed in the biocompatible matrix by injecting the PDGF solution into the biocompatible matrix. In some embodiments, injecting the PDGF solution can include disposing the PDGF solution in...

Embodiment 1

[0126] Preparation of compositions comprising PDGF solutions and biocompatible matrices

[0127] Compositions comprising PDGF solutions and biocompatible matrices were prepared as follows.

[0128] Obtain a pre-weighed batch of biocompatible matrix containing β-TCP and collagen. The β-TCP comprises β-TCP particles having an average diameter between about 100 μm and about 300 μm. The β-TCP particles were formulated with about 20% by weight soluble bovine type I collagen binder. The β-TCP / collagen biocompatible matrix is ​​commercially available from Kensey Nash (Exton, Pennsylvania).

[0129] A solution containing rhPDGF-BB is obtained. A stock solution of rhPDGF-BB in sodium acetate buffer at a concentration of 10 mg / ml (ie, lot number QA2217) was purchased from Novartis Corporation. The rhPDGF-BB is produced by Chiron Corporation in the yeast expression system, and the rhPDGF-BB used in the products REGRANEX (Johnson & Johnson) and GEM 21S (BioMimetic Therapeutics) comes fr...

Embodiment 2

[0132] Methods of inhibiting secondary vertebral compression fractures

[0133] Experimental Design and Overview

[0134] This prospective randomized, controlled, single-centre clinical trial was to evaluate a composition comprising PDGF solution formulated in a tricalcium phosphate matrix for inhibiting high-risk vertebral bodies during vertebral compression fracture kyphoplasty (FFVB) Efficacy in secondary compression fractures. A comparison was made between vertebral bodies treated with the [beta]-tricalcium phosphate+rhPDGF-BB composition and untreated vertebral bodies. This study is a pilot clinical trial to support the evidence or principle that β-TCP+rh-PDGF-BB prevents or reduces the possibility of secondary vertebral compression fractures by increasing HVB bone formation.

[0135] This study was performed in a total of up to 10 patients requiring prophylactic treatment of HVB at the time of kyphoplasty. Potential patients were screened to determine if they met incl...

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Abstract

The present invention relates to compositions and methods useful for treating structures of the vertebral column, including vertebral bodies. In one embodiment, a method for promoting bone formation in a vertebral body comprising providing a composition comprising a PDGF solution and a biocompatible matrix and applying the composition to at least one vertebral body. Promoting bone formation in a vertebral body, according to some embodiments, can increase bone volume, mass, and / or density leading to an increase in mechanical strength of the vertebral body treated with a composition of the present invention.

Description

[0001] Related application materials [0002] This application is hereby claimed under PCT Title I, Clause 8 and 35 U.S.C. §119(e) of U.S. Provisional Patent Serial Nos. 60 / 933,202 filed June 4, 2007 and filed February 7, 2008 Priority of US Provisional Patent Serial No. 61 / 026,835, both of which are incorporated herein by reference. field of invention [0003] The present invention relates to compositions and methods for treating spinal structures including vertebral bodies. Background of the invention [0004] Musculoskeletal problems occur in all age groups and in both genders. According to extensive published articles presented at the American Academy of Orthopedic Surgeons (AAOS) 2003 Annual Meeting, half of all Americans will require fracture services at some point in their lifetime. According to the report, more than $10 billion is spent annually in the United States on inpatient care related to bone fracture treatment. [0005] Vertebral compression fracture (VCF)...

Claims

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Application Information

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IPC IPC(8): A61K38/18A61L24/00
CPCA61L2300/414A61L2430/38A61L2300/44A61K38/1858A61L27/227A61L27/54A61P19/08
Inventor C·E·哈特S·E·林奇C·S·杨D·佩里恩
Owner BIOMIMETIC THERAPEUTICS INC
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