CELL IMPREGNATED SLEEVE FOR PARACRINE AND OTHER FACTOR PRODUCTION

• US 20160235956A1
• Filed: 10/07/2014
• Published: 08/18/2016
• Est. Priority Date: 10/08/2013
• Status: Active Grant

• Current Assignee: Johns Hopkins University
• Original Assignee: Gorden Tomaselli, Johns Hopkins University, Robert Weiss, SCHULMAN, Steven
• Inventors: Tomaselli, Gordon, Hwang, Chao-Wei, Xia, Zhiyong, Bogdan, Virginia E., Brinker, Jeffrey A., Gerstenblith, Gary, Johnston, Peter V., Schulman, Steven P., Weiss, Robert G.
• Granted Patent: US 10,561,830 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61L 33/08 : Polysaccharides
• CPC Class Codes: A61M 2202/09 : Body tissue
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Certain embodiments according to the present invention provide sleeve devices suitable for a wide range of therapeutic uses. In accordance with certain embodiments, the therapeutic sleeve device includes a nanofiber fabric assembly, which defines a plurality of pores, and at least one layer of cells embedded in the nanofiber fabric assembly.

Claims

1. A therapeutic sleeve device, comprising:

(a) a nonwoven fiber fabric assembly; and

(b) a plurality of cells embedded in the nonwoven fiber fabric assembly, wherein the nonwoven fiber fabric assembly defines a plurality of pores.

2. The therapeutic sleeve device according to claim 1, wherein the nonwoven fiber fabric assembly comprises a first nonwoven fiber fabric layer and a second nonwoven fiber fabric layer and the embedded cells are embedded between the first nonwoven fiber fabric layer and the second nonwoven fiber fabric layer.

3. The therapeutic sleeve device according to claim 1, wherein the nonwoven fiber fabric assembly comprises a nanofiber fabric assembly.

4. The therapeutic sleeve device according to claim 1, wherein the embedded cells are stem cells.

5. The therapeutic sleeve device according to claim 4, wherein the stem cells are mesenchymal stem cells.

6. The therapeutic sleeve device according to claim 1, wherein the sleeve device allows the embedded cells to produce and release paracrine factors.

7. The therapeutic sleeve device according to claim 1, wherein the embedded cells have a cell diameter, the pores have a maximal pore size, and the maximal pore size is less than the embedded cell diameter.

8. The therapeutic sleeve device according to claim 7, wherein the maximal pore size is less than host foreign cell diameters.

9. The therapeutic sleeve device according to claim 8, wherein host foreign cells comprise host immune cells.

10. The therapeutic sleeve device according to claim 7, wherein an average pore size is greater than embedded cell product, nutrient, or waste diameters.

11. The therapeutic sleeve device according to claim 7, wherein the maximal pore size is less than about 15-20 microns and the average pore size is greater than about 100 nanometers, the embedded cell diameter is about 20 microns, and growth factor diameters are less than 100 nanometers.

12. The therapeutic sleeve device according to claim 7, wherein the maximal pore size is less than about 15-20 microns and the average pore size is greater than about 300 nanometers, the embedded cell diameter is about 20 microns, and exosome diameters are about 300 nanometers.

13. The therapeutic sleeve device according to claim 1, wherein the nonwoven fiber fabric assembly comprises at least one of a biodegradable material, a non-biodegradable material, a bioabsorbable material, or a non-bioabsorbable material.

14. The therapeutic sleeve device according to claim 13, wherein the nonwoven fiber fabric assembly comprises at least one synthetic material, biological material, or any combination thereof.

15. The therapeutic sleeve device according to claim 14, wherein the nanofiber fabric assembly comprises at least one of poly(lactic acid), poly(L-lactic acid), poly(lactic-co-glycolic acid) copolymer, polycaprolactone, or polyethylene terephthalate.

16. The therapeutic sleeve device according to claim 14, wherein the nanofiber fabric assembly comprises at least one of collagen, peptides, proteins, nucleic acids, fatty acids, gelatin, chitosan, or hyaluronic acid.

17. The therapeutic sleeve device according to claim 1, further comprising at least one layer of adhesion molecules.

18. The therapeutic sleeve device according to claim 17, wherein the adhesion molecules comprise at least one of fibronectin, fibrinogen, laminins, collagen, vitronectin, proteoglycans, arginyl-glycyl-aspartic (RGD) acid peptides, or cell specific antibodies.

19. The therapeutic sleeve device according to claim 18, wherein the cell specific antibodies comprise anti-CD29 antibody.

20. The therapeutic sleeve device according to claim 1, further comprising at least one layer of an antithrombotic material.

21. The therapeutic sleeve device according to claim 20, wherein the antithrombotic material comprises at least one of an anticoagulant or an anti-platelet agent.

22. The therapeutic sleeve device according to claim 21, wherein the anticoagulant comprises at least one of heparin or enoxaparin.

23. The therapeutic sleeve device according to claim 21, wherein the anti-platelet agent comprises a glycoprotein IIB/IIIA inhibitor.

24. The therapeutic sleeve device according to claim 1, further comprising at least one layer of controlled release polymers and agent-releasing materials.

25. The therapeutic sleeve device according to claim 24, wherein the agent-releasing materials release agents comprising at least one of drugs, proteins, growth factors, cell nutrients, anticoagulants, anti-platelet agents, or anti-inflammatory agents.

26. A method of treatment, comprising:

(a) preparing a therapeutic sleeve device comprising a nonwoven fiber fabric assembly and a plurality of cells embedded in the nonwoven fiber fabric assembly, wherein the nonwoven fiber fabric assembly defines a plurality of pores; and

(b) wrapping the therapeutic sleeve device around an object,

wherein the therapeutic sleeve device prevents embedded cell dilution and washout and protects the embedded cells from the immune system of the subject.

27. The method of treatment according to claim 26, wherein the object comprises a tissue, an organ or portion of an organ, a blood vessel, or a bypass graft.

28. The method of treatment according to claim 26, wherein the object comprises a medical instrument.

29. The method of treatment according to claim 28, wherein the medical instrument comprises stents, pacemakers, implantable cardioverter-defibrillators, pacemaker leads, implantable cardioverter-defibrillator leads, biventricular implantable cardioverter-defibrillator leads, artificial hearts, artificial valves, ventricular assist devices, balloon pumps, catheters, central venous lines, orthopedic implants, wound healing packing, or wound healing gauze.

30. The method of treatment according to claim 28, wherein the medical instrument comprises a stent.

31. The method of treatment according to claim 30, wherein the stent comprises a bare metal stent, a drug-eluting stent, a stent graft, or a biodegradable scaffold.