Implantable stent with endothelialization factor

• US 20060085062A1
• Filed: 09/08/2005
• Published: 04/20/2006
• Est. Priority Date: 11/28/2003
• Status: Abandoned Application

• Current Assignee: Medlogics Device Corporation
• Original Assignee: Medlogics Device Corporation
• Inventors: Peacock, James C. III, Lee, Randall J., Colley, Kenneth J.
• Application Number:
  US11/223,741
• Publication Number:
  US 20060085062A1
• Time in Patent Office: Days
• US Class Current: 623/1.390
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A stent is provided in combination with a growth factor, specifically pleiotrophin or an analog or derivative thereof, which promotes endothelialization of the stent and re-endothelialization of the stented region of an injured site in a body lumen. In particular applications, the stent is an endolumenal stent and the growth factor promotes healing via endothelialization and substantially prevents restenosis. The growth factor is delivered from the stent formulated as a protein or peptide, or as a gene transfer vector. Methods for the treatment of vascular injury using pleiotrophin are also disclosed.

Claims

1. An endolumenal stent system for promoting endothelialization of vascular injury sites, comprising:

an endolumenal stent;

a porous surface on the endolumenal stent having a plurality of pores; and

a composite material located within each of the pores and comprising a bioerodable material in combination with a therapeutically effective amount of a bioactive agent.

2. The endolumenal stent system of claim 1, wherein the composite material comprises a plurality of particles.

3. The endolumenal stent system of claim 2, wherein the particles comprise a bioerodable polymer in combination with said bioactive agent.

4. The endolumenal stent system of claim 1, wherein said bioactive agent is a growth factor.

5. The endolumenal stent system of claim 4, wherein said growth factor is a biologically active endothelial growth factor.

6. The endolumenal stent system of claim 4, wherein said growth factor is pleiotrophin, or an analog or derivative thereof.

7. The endolumenal stent system of claim 6 wherein said pleiotrophin has the amino acid sequence of SEQ ID NO. 2 or a portion thereof.

8. The endolumenal stent system of claim 6 wherein said pleiotrophin has the nucleotide sequence of SEQ ID NO. 1 or a portion thereof.

9. The endolumenal stent system of claim 6 wherein said pleiotrophin is formulated as a protein or peptide.

10. The endolumenal stent system of claim 6 wherein said pleiotrophin is formulated as a gene transfer vector encoding a protein or a peptide.

11. The endolumenal stent system of claim 10 wherein said gene transfer vector is a plasmid.

12. A method for promoting vascular wound healing by induction of endothelialization of a vascular lesion comprising:

selecting a patient having a vascular wound; and

administering to said patient an effective amount of a bioactive agent capable of inducing endothelialization to the vascular lesion site.

13. The method of claim 12 wherein said bioactive agent is a growth factor.

14. The method of claim 13 wherein said growth factor is a biologically active endothelial growth factor.

15. The method of claim 13 wherein said growth factor is pleiotrophin, or an analog or derivative thereof.

16. The method of claim 15 wherein said pleiotrophin is formulated as a protein or peptide.

17. The method of claim 15 wherein said pleiotrophin is formulated as a gene transfer vector encoding a protein or a peptide.

18. The method of claim 17 wherein said gene transfer vector is a plasmid.

19. The method of claim 12 wherein said bioactive agent is delivered to said vascular lesion site by a drug-eluting stent.

20. The method of claim 12 wherein said bioactive agent is delivered to said vascular lesion site by a drug-eluting angioplasty balloon.

21. The method of claim 12 wherein said bioactive agent is delivered to said vascular lesion site by an injection catheter.