INJECTABLE BIOCOMPATIBLE COMPOSITION

• US 20100322993A1
• Filed: 07/27/2010
• Published: 12/23/2010
• Est. Priority Date: 01/28/2008
• Status: Active Grant

• Current Assignee: NMI Naturwissenschaftliches und Medizinisches Institut an an der Universität Tübingen. (NMI Natural and Medical Sciences Institute at the University TÜBINGEN)
• Original Assignee: NMI Naturwissenschaftliches und Medizinisches Institut an an der Universität Tübingen. (NMI Natural and Medical Sciences Institute at the University TÜBINGEN)
• Inventors: Benz, Karin, Platz, Barbara, Mollenhauer, Juergen, Wurst, Helmut, Stoop, Reinout
• Granted Patent: US 10,500,154 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis

Abstract

The invention relates to an injectable biocompatible composition based on a polymeric support as well as to a method for producing it, which composition which comprises at least one hydrophilic polymer, wherein the polymer is polymerizable in situ to form a gel, and wherein the hydrophilic polymer is crosslinkable serum albumin or crosslinkable serum protein. The composition can be used in the restoration, the reconstruction, and/or the replacement of tissues and/or organs, or as a drug release implant in mammals. The composition is particularly suitable for treating cartilage disorders of a diseased or injured articular site in a mammal.

Claims

1. An injectable biocompatible composition based on a polymeric support which comprises at least one hydrophilic polymer, wherein the polymer is polymerizable in situ to form a gel, wherein the hydrophilic polymer is crosslinkable serum albumin or crosslinkable serum protein and wherein the serum albumin or the serum protein is functionalized by groups which are selected from maleimide, vinyl sulfone, acrylate, alkyl halide, azirine, pyridyl, thionitrobenzoic acid groups, or arylating groups, wherein the serum albumin or the serum protein is crosslinkable via the groups.

2. The composition as claimed in claim 1, wherein it further comprises at least one of the following, namely, mammalian cells, a pharmacological agent, a biologically active agent, or one or more or mixtures thereof.

3. The composition as claimed in claim 1, wherein the serum albumin and the serum protein are human serum albumin and human serum protein.

4. The composition as claimed in claim 1, wherein it further comprises mammalian cells, the mammalian cells being selected from skeletal muscle cells, more particularly chondrocytes, osteocytes, fibrochondrocytes, and also metabolism-regulating glandular cells, islet cells, melatonin-producing cells, progenitor cells and stem cells, more particularly mesenchymal stem cells.

5. The composition as claimed in claim 1, wherein it further comprises a pharmacological agent, the pharmacological agent being selected from at least one of the following:

an antibiotic, an anti-inflammatory, a metabolism hormone, chondroprotectives, agents for gene therapy, growth hormones, differentiation or modulation factors, immunosuppressives, immunostimulatory substances, DMOAs, nucleic acids, apoptosis-inducing actives, adhesion-mediating actives, receptor agonists and receptor antagonists, or mixtures thereof.

6. The composition as claimed in claim 1, wherein the albumin concentration in the gel is from about 5 to about 15 mg/ml gel, more particularly about 10 mg/ml gel.

7. The composition as claimed in claim 1, wherein the biologically active agent is hyaluronic acid.

8. The composition as claimed in claim 1, wherein the hyaluronic acid concentration in the gel is from about 1 to about 10 mg/ml gel, more particularly about 4 mg/ml gel.

9. The composition as claimed in claim 1 for use as a whole or as a component in implantable devices or in implants for use in the restoration, the reconstruction, and/or the replacement of tissues and/or organs, or as a drug release implant in mammals.

10. The composition as claimed in claim 1 for treating cartilage disorders of a diseased or injured articular site in a mammal.

11. A process for preparing an injectable biocompatible composition having at least one hydrophilic polymer which is polymerizable in situ to form a gel, comprising the following steps:

a) providing human serum or human serum albumin;

b) functionalizing the serum or serum albumin with maleimide, vinyl sulfone, acrylate, alkyl halide, azirine, pyridyl, thionitrobenzoic acid, or derivatives thereof, or arylating groups;

c) optionally adding mammalian cells, a pharmacological agent, a biologically active agent, or mixtures thereof; and

d) adding a crosslinker for crosslinking the serum protein or serum albumin functionalized in step b).

12. Method for treating cartilage disorders of a diseased or injured articular site in a mammal, said method comprising the steps of providing an injectable biocompatible composition based on a polymeric support which comprises at least one hydrophilic polymer, wherein the polymer is polymerizable in situ to form a gel, wherein the hydrophilic polymer is crosslinkable serum albumin or crosslinkable serum protein and wherein the serum albumin or the serum protein is functionalized by groups which are selected from maleimide, vinyl sulfone, acrylate, alkyl halide, azirine, pyridyl, thionitrobenzoic acid groups, or arylating groups, wherein the serum albumin or the serum protein is crosslinkable via the groups, and injecting the compositions into the articular site to be treated.

13. The method as claimed in claim 12, wherein the composition is used for replacing and/or for regenerating articular cartilage, intervertebral discs, bone tissue, tissue-building cells, and metabolism-regulating secretory cells.