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Method For Use Of A Double-Structured Tissue Implant For Treatment Of Tissue Defects

a tissue implant and double-structure technology, applied in the field of tissue implant use, can solve the problems of uneven and uncontrolled porosity, difficult handling of structures, and many of the above disclosed structures

Inactive Publication Date: 2009-02-26
HISTOGENICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The patent describes a method for making a double-structured tissue implant for treating tissue defects. The implant has two distinct structures, each with different properties, that can be independently loaded with cells or drugs. The primary scaffold is a porous structure made from collagen with randomly oriented open pores, while the secondary scaffold is a qualitatively different structure formed within the primary scaffold. The secondary scaffold can be made from a solution containing collagen and a non-ionic surfactant. The implant can be used as a standalone implant or in combination with an adhesive. The invention also includes a process for preparing the double-structured implant by introducing a solution containing collagen and a non-ionic surfactant into the pores of a primary scaffold, stabilizing it, and processing it to form a distinctly structurally and functionally different second scaffold within the pores of the primary scaffold."

Problems solved by technology

However, many of the above disclosed structures have uncontrolled parameters such as uneven and uncontrolled porosity, uneven density of pores, uneven sizes of the pores and random distribution of pores within the support matrix.
Such uncontrolled parameters lead to usable pore structures that represent only a small percentage of the total implant.
Additionally, when introduced into tissue defects or cartilage lesions during the surgery, these structures are difficult to handle as they are unstable and do not have appropriate wetting properties in that they can shrink or swell and are not easily manipulated by the surgeon.
However, even with the above-described improvements, a solution to problems faced by the surgeon during surgery is still lacking.
A practicality needed for routine use of the tissue implants, such as, for example, the articular cartilage implants by the orthopedic surgeons, where the implant needs to be readily available, manipulatable, wettable, stable, sterile and able to be rapidly prepared and used for implantation, is still not achieved.

Method used

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  • Method For Use Of A Double-Structured Tissue Implant For Treatment Of Tissue Defects
  • Method For Use Of A Double-Structured Tissue Implant For Treatment Of Tissue Defects
  • Method For Use Of A Double-Structured Tissue Implant For Treatment Of Tissue Defects

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of the Primary Scaffold

[0252]This example describes one exemplary method for preparation of the collagen-based primary scaffold suitable as a structural support for preparation of the DSTI. Type I collagen is dissolved in a weak hydrochloric acid solution at pH 3.0 with the collagen concentration and osmolality of the solution adjusted to about 3.5 mg / ml and 20 mOsm / kg, respectively. The solution (70 ml) is poured into a 100 ml Petri dish and the Petri dish containing the collagen solution is centrifuged at 400×g for 30 minutes to remove air bubbles. Neutralization and subsequent precipitation or gelling is carried out in a 7 liter chamber containing 10 ml of 15% ammonia solution over a 45 minutes period. The precipitated collagen is then washed in a large excess of de-ionized water. The water is changed as many times as needed over next 3 days to remove formed salts and excess ammonia.

[0253]The solution is then subjected to unidirectional freezing over a period of about...

example 2

Preparation of a Basic Solution for a Secondary Scaffold

[0255]This example describes preparation of the Basic Solution used for formation of the secondary scaffold. The Basic Solution comprises a soluble collagen in admixture with a PLURONIC® surfactant. The Basic Solution is incorporated into the primary scaffold and processes into the double scaffold tissue implant or processed as a stand alone implant.

[0256]Solution for the secondary scaffold is prepared by mixing PLURONIC® F127 (2.32 mg, 0.29 mg / ml), obtained commercially from BASF, Germany, with 8 ml of a solution containing 2.9 mg / ml bovine type I collagen dissolved in hydrochloric acid (pH 2.0) at room temperature. The resulting solution is neutralized with 1 ml of 10× Dulbecco=s phosphate buffered saline (DPBS) and 1 ml of 0.1M NaOH to the final pH of 7.4.

[0257]In the alternative, the neutralization is achieved by ammonia aqueous solution or ammonia vapor in concentration sufficient to neutralize acid within the collagen sol...

example 3

Preparation of the Secondary Scaffold as Stand Alone Unit

[0258]This example illustrates preparation of the secondary scaffold as a stand alone implant or stand alone unit. For preparation of the stand alone secondary scaffold, the Basic Solution prepared in Example 3 is subjected to precipitation or gelling followed by dehydrothermal treatment.

[0259]The Basic Solution (2 ml) comprising collagen and PLURONIC® surfactant is placed in a small glass beaker and the beaker is placed into a chamber (approximately 9 liters) charged with 1% ammonia solution. The Basic Solution is allowed to precipitate in the chamber over a period of 15 minutes. The gelled or precipitated collagen is then washed in 500 ml of deionized water over a period of 30 minutes. The washing step is repeated three times. The washed gel or precipitate is placed on metal shelf of a freezer at −80° C. over a period of 30 minutes. The frozen gel or precipitate is removed from the freezer and lyophilized. Lyophilization is ...

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Abstract

A method for use of a double-structured tissue implant or a secondary scaffold stand alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A method of use of a stand alone secondary scaffold implant or unit for treatment of tissue defects.

Description

BACKGROUND OF THE INVENTION[0001]This application is a Continuation-in-Part of the application Ser. No. 11 / 982,268, filed on Oct. 31, 2007 which is Continuation-in Part of the application Ser. No. 11 / 894,124, filed on Aug. 20, 2007, and claims priority of the Provisional application Ser. No. 60 / 967,886, filed Sep. 6, 2007 and 60 / 958,401, filed Jul. 3, 2007, all incorporated herein by reference.FIELD OF INVENTION[0002]The current invention concerns a method for use of a double-structured tissue implant for implantation into tissue defects. In particular, the invention concerns use of a double-structured tissue implant comprising a primary scaffold and a secondary scaffold generated and positioned within the primary scaffold. The primary scaffold is a porous collagen-comprising material having randomly or non-randomly oriented pores of substantially homogeneous defined diameter. Under the most favorable conditions, the pores are through oriented, mostly vertically, and represent a hig...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/28A61B19/00A61B17/08
CPCA61F2/30756A61F2002/30075A61F2002/30766A61F2002/3092A61F2210/0061A61F2310/00365A61L27/54A61L27/48A61L27/56C07K14/78A61L27/24A61L27/44C08L89/06A61F2210/0076A61F2310/00389A61F2/02A61L27/34A61L27/3604A61L2420/06A61L2430/06
Inventor SHORTKROFF, SONYATARRANT, LAURENCE J. B.ROOS, ERIC J.SMITH, ROBERT LANECLAESSON, HANS P. I.
Owner HISTOGENICS
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