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Insulin-mimetics as therapeutic adjuncts for bone regeneration

a technology of imitation agents and therapeutic adjuncts, applied in the field of imitation agents, can solve the problems of large differences in bone metabolism processes and methods, and cost about $5,000 per application, and achieve the effects of promoting bone healing, reducing costs, and enhancing spinal fusion

Inactive Publication Date: 2014-10-30
RUTGERS THE STATE UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a new method for promoting bone healing and enhancing spinal fusion in humans. This is done by using an insulin-mimetic agent that increases the rate of fusion of two vertebrae with bone tissue material. This method can be used in spinal fusion surgical procedures and may eliminate the need for specialized methods to deliver complex molecules, reducing costs and improving ease of use. The invention also involves a bone tissue kit that includes an insulin-mimetic agent and / or allograft bone material. Overall, this invention provides a better method for promoting bone healing and spinal fusion.

Problems solved by technology

The latter has been approved by FDA as an autograft replacement in spine fusion (ALIF) with specific interbody cages (2002), as an adjuvant for repair of tibia fractures with IM nail (2004), and for craniofacial maxillary surgery (2006), but this method is expensive, costing about $5,000 per application.
However, the processes of bone metabolism are vastly different from bone repair.

Method used

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  • Insulin-mimetics as therapeutic adjuncts for bone regeneration
  • Insulin-mimetics as therapeutic adjuncts for bone regeneration
  • Insulin-mimetics as therapeutic adjuncts for bone regeneration

Examples

Experimental program
Comparison scheme
Effect test

example 1

Use of Zinc Compounds to Accelerate Bone Fracture Healing

Materials and Methods

the BB Wistar Rat Model

Animal Source and Origin

[0132]Diabetic Resistance (DR) BB Wistar rats used in the study were obtained from a breeding colony at UMDNJ-New Jersey Medical School (NJMS). The rats were housed under controlled environmental conditions and fed ad libitum. All research protocols were approved by the Institutional Animal Care and Use Committee at University of Medicine and Dentistry of New Jersey-New Jersey Medical School.

Diabetic Resistant BB Wistar Rats

[0133]A total of 24 DR BB Wistar rats were utilized in the study. Due to unstable fixation during mechanical testing, three samples were removed. Another sample was removed due to complications associated with a post-operative infection. The remaining 17 animals were used for mechanical testing and were distributed between the control saline (n=6), 0.1 mg / kg zinc chloride (n=2), 1.0 mg / kg zinc chloride (n=3), 3.0 mg / kg zinc chloride (n=3), ...

example 2

Use of Manganese Compounds for Fracture Healing

Material and Methods

Rat Model

[0165]The animal model used for this study is the Diabetes Resistant (DR) BB Wistar Rat. It will be obtained from a breeding colony at UMDNJ-New Jersey Medical School (NJMS) which is maintained under controlled environmental conditions and fed ad libitum.

[0166]The BB Wistar colony was established from diabetic-prone BB Wistar rats originally obtained from BioBreeding (Toronto, Canada). Similar to human type I diabetes, spontaneously diabetic BB Wistar rats display marked hyperglycemia, glycosuria and weight loss within a day of onset, associated with decreased plasma insulin after undergoing selective and complete destruction of pancreatic β-cells. If left untreated, diabetic BB Wistar rats would become ketoacidic within several days, resulting in death. Genetic analysis of the BB-Wistar rat shows the development of diabetes is strongly related to the presence of the iddm4 diabetogenic suceptibility locus on...

example 3

Use of Vanadium Compounds for Bone Fracture Healing

Method

General Description of Animal Surgery

[0177]A closed mid-diaphyseal fracture surgery was performed on the right femur of each rat as described previously. General anesthesia was administered by intraperitoneal injection of ketamine (60 mg / kg) and xylazine (8 mg / kg). A closed, midshaft fracture was then created using a three-point bending fracture instrument (BBC Specialty Automotive, Linden N.J.) and confirmed with X-rays immediately post-fracture.

Preparation of VAC Solution

[0178]Vanadyl acetylacetonate (VAC), Sigma Aldrich, St. Louis, Mo., mixed with sterile water at various doses with or without a calcium sulfate carrier, were injected into the intramedullary canal prior to fracture. VAC was chosen over alternative organo-vanadium compounds such as BMOV and VS, due to its' observed superior potency at stimulating protein kinase B (PKB), Glycogen synthase kinase 3 beta (GSK-3β), and protein tyrosine phosphorylation (PTP). Addi...

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Abstract

Methods of promoting bone healing or regeneration by locally administering insulin mimetic agents to patients in need thereof and new uses of insulin-mimetic compounds for accelerating bone-healing processes are disclosed. Bone injury treatment and void filler devices, products and kit suitable for local administration of insulin-mimetic agents or compositions thereof to patients in need of such treatment are also disclosed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61 / 564,822, filed on Nov. 29, 2011, and No. 61 / 718,646, filed on Oct. 25, 2012, and claims priority to International Application No. PCT / US11 / 64240, filed on Dec. 9, 2011, which in turn claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61 / 421,921, filed on Dec. 10, 2010, No. 61 / 428,342, filed on Dec. 30, 2010, and No. 61 / 454,061, filed on Mar. 18, 2011, all of which are hereby incorporated by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates to use of insulin-mimetic agents as therapeutic adjuncts for bone regeneration and methods for bone healing or regeneration in patients by local administration of insulin-mimetic agents.BACKGROUND OF THE INVENTION[0003]About six million bone fractures, including about 600,000 non-union cases, occur annually in the United St...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K33/32A61F2/30A61K45/06A61L31/16A61K33/30A61K31/28A61B17/70A61F2/44A61K33/24
CPCA61K33/32A61B17/70A61F2/30767A61F2/4455A61F2002/3093A61L31/16A61K33/30A61K31/28A61K45/06A61B17/7094A61B17/7061A61B17/866A61B2017/561A61B2017/564A61K33/00A61K33/24A61K31/315A61K31/69A61L27/54A61L2300/414A61L2430/02A61L2430/38A61F2210/0085A61K2300/00A61F2002/30593
Inventor LIN, SHELDON S.PAGLIA, DAVID N.O'CONNOR, JAMES P.BENEVENIA, JOSEPHWEY, AARONSUBRAMANIAN, SANGEETAKOERNER, JOHN D.
Owner RUTGERS THE STATE UNIV
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