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Tissue implants and methods for making and using same

a technology of tissue implants and implants, which is applied in the field of tissue repair, can solve the problems of undesirable platelet activation with bovine thrombin, inherent risk of transmitting unwanted agents, for example prions, and achieve the effect of increasing the temperature of the sampl

Inactive Publication Date: 2009-04-16
INTINI GIUSEPPE +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides a family of biodegradable matrices that can be used to promote tissue growth in mammals, particularly bones. These matrices are made by exposing platelets to a process where a partially or completely dehydrated exothermic salt, such as calcium sulfate, becomes rehydrated in aqueous solution. This activation process does not require the use of thrombin, which can be inconsistent and may transmit unwanted agents. The resulting matrices contain both calcium sulfate crystals and activated platelets, which induce growth factors that promote bone formation. These matrices can be used to repair bone defects and fractures, and may also contain other pharmaceutically active agents or nucleic acids for gene therapy.

Problems solved by technology

However, activation of the platelets with bovine thrombin may be undesirable because (i) the bovine thrombin may not be fully characterized and may vary from batch to batch, and (ii) this approach has the inherent risk of transmitting unwanted agents, for example, prions, from the source of the thrombin to the intended recipient of the matrix.

Method used

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  • Tissue implants and methods for making and using same
  • Tissue implants and methods for making and using same
  • Tissue implants and methods for making and using same

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0055]This Example demonstrates that calcium sulfate may be used to activate platelets in platelet-rich plasma.

(a) Materials

[0056]In this Example, and in the following Examples, exothermic calcium sulfate was obtained from LIFECORE Biomedical, Chaska Minn., USA under the tradename CAPSET®, a medical grade calcium sulfate alpha-hemihydrate powder. Platelet-rich plasma was purchased from the American Red Cross, Buffalo N.Y. Bovine thrombin and Collagen Type I (from rat tail) were obtained from Sigma (Saint Louis, Mo.). Human recombinant Platelet-derived Growth Factor (rePDGF-BB) was obtained from Oncogene Research Products (Cambridge, Mass.). Anti-human Transforming Growth Factor-β1 antibody (IgG fraction of antiserum, developed in Mouse) was obtained from Oncogene Research Products (Cambridge, Mass.). Anti-human Platelet-derived Growth Factor antibody (IgG fraction of antiserum, developed in Goat), Purified Mouse IgG and Purified Goat IgG were obtained from Sigma (Saint Louis, Mo.). ...

example 2

[0076]This example again demonstrates that platelet-rich plasma can be activated by exposure to calcium sulfate. Furthermore, this example demonstrates that part of the benefit of including platelet-rich plasma in the calcium sulfate matrices can be derived in part by the release of PDGF and / or TGF-β. Samples were created as summarized in Table 2 using the procedures essentially as described in Example 1, to generate the same disk sizes as in Example 1.

TABLE 2Group NameGroup Treatment (at 37° C.)CSPBS for 1 hourCS / PRPPBS for 1 hourCS / PRP-Antibody orAnti-PDGF for 30 min thenCS / AntibodyAnti-TGF-β1 for 30 minCS / PRP-IgGGoat IgG for 30 min then mouse IgG for 30 minCS / PRP-Refrig6 hour incubation at 7-8° C.CS / PDGF-BBPBS for 1 hour

[0077]In this example, the CS / PRP group was also refrigerator-treated (CS / PRP-Refrig), because calcium sulfate precipitation reaction is an exothermic reaction and achieves, during the 30-50 minutes setting time, a temperature of 40-45° C. (Phillips, 1991, supra, ...

example 3

[0081]This example provides comparative data, which indicates that calcium sulfate-platelet-rich plasma matrices can support a similar levels of osteoblastic cell proliferation as commercially available Grafton® Putty.

[0082]Samples were prepared in accordance with the teachings of Examples 1 and 2. Grafton® Putty, a demineralized bone matrix, was obtained from Osteotech Inc. (Eatontown, N.J.). The Grafton® Putty samples (GraftonPutty) were prepared using the same polyvinylsiloxane templates: the special malleability of this bone matrix compound permitted the preparation of samples of the same standard size disk as in all other preparations.

[0083]The osteoblastic cell proliferation assay, and the data resulting therefrom was analyzed as discussed in Example 1. The results are summarized in FIG. 4. wherein human primary osteoblastic cell proliferation is indicated counts per minute (cpm). The results in FIG. 4 demonstrate that human primary osteoblastic cells cultured on CS / PRP sample...

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Abstract

The invention provides biocompatible, biodegradable calcium sulfate matrices containing calcium sulfate activated platelets for use in tissue formation. The matrices are particularly useful in stimulating hard tissue, for example, bone formation. The matrices may also further include a growth factor and / or a transfectable gene, the inclusion of which may be useful in stimulating the growth of tissue of interest.

Description

RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 10 / 216,552, filed Aug. 9, 2002, which claims the benefit of U.S. Patent Application Ser. No. 60 / 311,216, filed Aug. 9, 2001, which are incorporated by reference herein.FIELD OF THE INVENTION[0002]This invention relates generally to tissue repair, and more particularly to a bioactive matrix, methods of making such a matrix, and methods of using such a matrix for promoting hard tissue formation.BACKGROUND OF THE INVENTION[0003]The formation of bone is a dynamic process that starts during embryogenesis and continues, though remodeling, during adult life. Occasionally, bone can also be regenerated when bone repair is needed. A complex series of events, involving cellular growth and differentiation together with extracellular matrix formation, are required for bone formation. A similar sequence of events takes place during bone repair.[0004]The process of bone repair and regeneration resemble...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/14A61P19/00A61K35/14A61L27/00A61K35/16A61K35/19C12N5/08
CPCA61K33/06A61K35/16A61K35/19A61K38/1858A61L27/10A61L27/54A61L2300/258A61L2300/414A61K2300/00A61P19/00
Inventor INTINI, GIUSEPPEANDREANA, SEBASTIANODZIAK, ROSEMARYBOBEK, LIBUSE ANNA
Owner INTINI GIUSEPPE