Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Animal or plant cell
Patent
1996-05-09
1998-11-17
Naff, David M.
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Animal or plant cell
424422, 424520, 435176, 435177, 435180, 435395, 435396, 435402, C12N 506, C12N 508, C12N 1102, C12N 1108
Patent
active
058372350
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/CH95/00158, filed Jul. 6, 1995.
The invention relates to a process for producing implant materials with bone-regenerating and/or cartilage-regenerating characteristics.
BACKGROUND OF THE INVENTION
The healing of bone regression, such as can e.g. occur in connection with artificial prostheses, or the healing or treatment of serious bone damage caused by accidents can, according to the prior art, be brought about or improved/accelerated at the damaged points by inplantation of endogenic material, e.g. in the form of a mixture of ground bone material and blood. As a result of the vital osteoblasts present in the implanted bone material a regeneration of bone material is initiated or assisted at the damaged point. Such bone material autotransplantations are admittedly very complicated, but offer the best prospects to bring about healing and cure in very difficult cases.
The difficulties encountered in the autotransplantation of bone material are in particular that the removal of the material, e.g. from the iliac crest, represents a relatively serious operation and that the removable quantity, particularly in children is very small. As a result of these difficulties, autotransplantation of bone material as the method with the highest healing chances is only used in the most serious cases.
In order to overcome the problem of the quantitative availability of endogenic bone material, it has therefore been proposed to remove it from the patient and subsequently reproduce or propagate the osteoblasts contained therein in vitro (A. I. Caplan, J. Orthop, Res. 9, 641-650, 1991). M. J. Doherty et al. (Bone and Mineral 25, Suppl. 1, p 9, 1994) have shown on rats that in bone damage areas implanted, demineralized bone material, which was coated beforehand with in vitro propagated osteoblasts of rats, improved the healing of bone damage and in fact did so more than implanted, demineralized bone material without such a coating, which although assisting bone regeneration, can clearly not initiate the latter. The difference in the results of the two healing attempts was that when using demineralized bone material alone, there was only a bone growth from the edges of the damage, i.e. from the living, damaged bone, whereas when using coated bone material it started directly on the latter, i.e. from the centre of the damage. In many cases of treatment with only demineralized bone material radioulnar coalescence was observed, but this did not occur in the case of treatment with coated material.
Similar healing improvements were obtained by Shigeyukui Wakitani et al. (The Journal of Bone and Joint Surgery, vol. 76-A, No. 4, April 1994, pp 579 to 592), who used a collagen gel for the treatment of defects in stressed knee joint surfaces of rabbits and into said gel was incorporating endogenic cells extracted from the bone marrow or periosteum and which was cultured in vitro. It was found that the implant material in particular assisted and improved the regeneration of the joint cartilage, and also assisted in the regeneration of the underlying bone. It can be gathered from the tests described, that cells obtained from bone material (mesenchymal cells) are able to form bone or cartilage, as a function of the particular environment.
The advantage of a method in which bone material is taken from the patient, propagated in vitro and then implanted at the damaged point of a bone, compared with the direct autotransplantation method, is that there is a much larger quantity of vital material available for implantation purposes. The disadvantage is that for the removal or extraction of the material, the same difficult operation is needed, which must be separated in time from the implant operation by e.g. six weeks for in vitro culturing purposes.
SUMMARY OF THE INVENTION
The problem being addressed by this invention is to provide a process for producing an implant material with characteristics for regenerating bone and/or cartilage, with which the aforementioned disadvantages of the known methods are av
REFERENCES:
patent: 4458678 (1984-07-01), Yannas et al.
patent: 4609551 (1986-09-01), Coplan et al.
patent: 5041138 (1991-08-01), Vacanti et al.
Mueller Werner
Thaler Thomas
Naff David M.
Sulzer Medizinaltechnik AG
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