Process for producing an implant from cell cultures

Details Process for producing an implant from cell cultures Process for producing an implant from cell cultures

1996-09-06

1999-04-06

Crouch, Deborah

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

424422, 424423, 424424, 435325, 435366, 435382, A61F 200, C12N 500, C12N 502

Patent

active

058914552

DESCRIPTION:

BRIEF SUMMARY
CROSS-REFERENCE TO RELATED APPLICATION

This application is based on International Patent Application No. PCT/DE94/00235, filed Mar. 3, 1994, from application No. P 4306661.5, filed in Germany on Mar. 3, 1993, for which applicant claims priority under 35 U.S. C. 119(b).


BACKGROUND OF THE INVENTION

The invention relates to a method for the production of an implant from cell cultures, particularly an implant of cartilage cells whereby these cells are applied to an absorbable support structure and then implanted.
Should the body's own tissue be removed, so that cartilage, for example, must be replaced, two options are presently available. One option is that the required tissue may be taken from cadavers, preserved, and then implanted. In this case, immune reactions sometimes occur. The other option is to replace the removed tissue by implanting tissue taken from locations of the patient's own body which are not externally visible. Here, no risk of immune reactions is present.
A serious disadvantage of these two methods, however, is that an adequate amount of replacement tissue may not be available, so that the desired substitution of tissue cannot be completed.
Therefore, a third method has been proposed. In this method, cells which have been isolated and propagated in a conventional manner are applied to a polymer fiber bundle of absorbable material, and the bundle is implanted. See C. A. Vacanti et al., Plastic and Reconstructive Surgery 8 (5) 753-759, November 1991. By layering the bundle with superimposed and adjacent layers, the implant can be shaped somewhat in a three-dimensional manner. After implantation, the polymer material is absorbed, whereby simultaneously the intercellular matrix between the individual cells is formed from collagen, especially so that in the final stage a tissue structure results which is integrated into the surrounding tissue and is fully functional.
This third method is still in the trial stage with tests being conducted on animals, but has not yet been applied in human medicine.
Difficulties probably arise with this method in the shaping of the desired implant, because during the absorption of the fiber material, shape stability cannot be expected from the layers superimposed and adjacent to one another. Furthermore, for larger implants, difficulties result with the nourishment of the individual cells which lie inside the implant.


SUMMARY OF THE INVENTION

An objective of the present invention is to specify a method by which cell tissue, particularly cartilage, is made available in a configuration which is favorable for implantation. In particular, the implant should be easily molded and maintain its shape in the implanted state and assure secure nourishment of the individual cells in the implant.
This objective is achieved by a method according to the invention for production of an implant from cell cultures, particularly cartilage cells, in which the cells are applied to an absorbable support structure and are subsequently to be implanted together with it, characterized in that a three-dimensional, preformed support structure is fashioned, having a stable shape and corresponding to the desired form of the implant, with an interior cavity, from a material having a cohesive inner surface and low volume such as a nonwoven polymeric material, for example; cells are introduced into the interior cavity of the support structure; and the support structure containing the cells is perfused with a nutrient solution such that the nutrient solution flows through the support structure until an intercellular matrix which binds the cells together has at least partially formed, thereby constituting the specified implant with a stable three-dimensional support structure having the desired shape.
The fundamental concept of the invention resides in the preforming of the three-dimensional support structure with a stable shape suited to the location in which it is to be implanted, and which maintains its shape in the implanted state. The material from which it is formed, such as nonwoven p

REFERENCES:
Cima et al. Tissue engineering by cell transplantation using degradable polymer substrates. J. of Biomechanical Engineering, vol. 113, pp. 143-151., May 1991.

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