Bioengineered Allogeneic Valve
AssigneeNovahep AB
InventorsSuchitra Sumitran-Holgersson, Antonio Rosales, Jonny Hisdal
Life of this patent
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Abstract
The present disclosure relates to methods for recellularization of valves in valve-bearing veins. This method is useful for producing an allogeneic venous valve, wherein a donor valve-bearing vein is decellularized and then recelluiarized using whole blood or bone marrow stem cells. The allogeneic valves produced by the methods disclosed herein are advantageous for implantation, transplantation, or grafting into patients with vascular diseases.
Claims26
A method of recellularization of a valve in a vein, comprising introducing blood comprising progenitor cells for endothelial cells and progenitor cells for smooth muscle cells to the lumen of a decellularized vein, and culturing the cells in the lumen of the decellularized vein, thereby recellularizing the valve in the vein.
The method of one of the above claims, wherein the recellularized valve is CD31 positive, vWF positive, smooth muscle actin positive, and has nuclei.
The method of one of the above claims, wherein the recellularized valve has mechanical properties of withstanding force at first peak at or above 0.8 N.
The method of one of the above claims, wherein the recellularized valve has a closure time of equal to or less than 0.5 seconds.
A method of treating chronic venous insufficiency (CVI), deep vein thrombosis (DVT), and/or leg ulceration in a subject in need thereof, comprising introducing a recellularized valve-bearing segment of a vein to the subject, wherein the valve is recellularized by a method comprising:
- a) decellularizing a valve-bearing segment of a vein, wherein the vein is allogeneic to the subject;
- b) collecting blood from the subject, wherein the blood comprises progenitor cells for endothelial cells and progenitor cells for smooth muscle cells;
- c) perfusing the decellularized valve-bearing with the collected blood;
- d) culturing the cells in the lumen of the decellularized valve-bearing vein;
- thereby recellularizing the decellularized valve of the vein;
- and
- e) grafting the recellularized valve-bearing vein to the subject;
- wherein the grafting treats CVI and/or leg ulceration in the subject.
A method of recellularization of a valve in a valve-bearing vein, wherein the recellularized valve is a functional valve, the method comprising:
- a) harvesting a segment of a vein from a subject in need of the recellularized valve in a vein;
- b) decellularizing the valve-bearing vein;
- c) collecting blood from the subject, wherein the blood comprises progenitor cells for endothelial cells and progenitor cells for smooth muscle cells;
- d) perfusing the decellularized valve-bearing vein with the collected blood;
- and
- e) culturing the cells in the decellularized valve-bearing vein, thereby recellularizing the decellularized valve in the vein.
Dependencies are inferred from the claim text.