US2022072058A1PendingUtilityA1

Methods and compositions to facilitate repair of avascular tissue

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Assignee: REGENERATIVE SCIENCES LLCPriority: Dec 5, 2008Filed: Nov 16, 2021Published: Mar 10, 2022
Est. expiryDec 5, 2028(~2.4 yrs left)· nominal 20-yr term from priority
Inventors:Christopher J. Centeno
A61P 19/00A61K 38/18A61P 19/08A61K 38/19A61P 19/02A61K 35/28A61K 35/19A61K 35/12A61P 7/00
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Claims

Abstract

Compositions and methods are provided for repairing damaged avascular zones, including intervertebral disc, in a patient in need thereof.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treating a degenerative intervertebral disc in a patient in need thereof comprising:
 culturing harvested nucleated cells in a culture medium at an osmolarity of about 350 mOsm to about 600 mOsm for 1-28 days;   obtaining viable mesenchymal stem cells capable of growth in the culture medium at an osmolarity of about 350 mOsm to about 600 mOsm;   implanting the viable mesenchymal stem cells in a posterior disc annulus of the degenerative intervertebral disc; and   implanting autologous platelets or platelet lysate in the posterior disc annulus, either separately or in combination with the viable mesenchymal stem cells.   
     
     
         2 . The method of  claim 1  further comprising harvesting autologous platelets from the patient in need thereof. 
     
     
         3 . The method of  claim 1 , wherein the autologous platelets are implanted prior to, during or after implanting the viable mesenchymal stem cells. 
     
     
         4 . The method of  claim 2  wherein the autologous platelets are treated with thrombin and calcium chloride 1-7 days prior to implanting in the posterior disc annulus. 
     
     
         5 . The method of  claim 4  wherein the amount of thrombin is 28.56 U/ml and the amount of calcium chloride is 2.86 mg/ml. 
     
     
         6 . The method of  claim 2  wherein the autologous platelets are treated with thrombin, calcium chloride or its salts, thromboxane A2, adenosine triphosphate and arachidonate. 
     
     
         7 . The method of  claim 1  further comprising administering a compound selected from the group consisting of growth factors, cytokines, integrins, cadherins, molecules or drugs that promote angiogenesis, molecules or drugs that promote vasculogenesis, and molecules or drugs that promote arteriogenesis. 
     
     
         8 . The method of  claim 7  wherein the compound is selected from a group consisting of VEGF-A, PIGF, VEGF-B, VEGF-C, VEGF-D, TGF-β, Ang-1, Ang-2, IGF, HGF, FGF, Tie2, PDGF, CCL2, Alpha-V Beta-5, Alpha-5 Beta-1, VE-cadherin, PECAM-1, plasminogen activator, nitrogen oxide synthase, and combinations thereof. 
     
     
         9 . The method of  claim 1  further comprising administering one or more growth factors before, during or after implanting the viable mesenchymal stem cells in the posterior disc annulus. 
     
     
         10 . The method of  claim 9  wherein the one or more growth factor is selected from the group consisting of TGF-β, FGF, PDGF, and IGF. 
     
     
         11 . The method of  claim 1  wherein the culturing of harvested nucleated cells is performed in a basal culture media made from a D-MEM base. 
     
     
         12 . A method for treating an avascular zone in a patient in need thereof comprising:
 culturing harvested nucleated cells in a culture medium at an osmolarity of about 350 mOsm to about 600 mOsm for 1-28 days;   obtaining viable mesenchymal stem cells capable of growth in the culture medium at an osmolarity of about 350 mOsm to about 600 mOsm;   implanting the viable mesenchymal stem cells in the avascular zone; and   implanting autologous platelets or platelet lysate in the avascular zone, either separately or in combination with the viable mesenchymal stem cells.   
     
     
         13 . The method of  claim 12  further comprising harvesting autologous platelets from the patient in need thereof. 
     
     
         14 . The method of  claim 12 , wherein the autologous platelets are implanted prior to, during or after implanting the viable mesenchymal stem cells. 
     
     
         15 . The method of  claim 14  wherein the autologous platelets are treated with thrombin and calcium chloride 1-7 days prior to implanting in the avascular zone. 
     
     
         16 . The method of  claim 14  wherein the autologous platelets are treated with thrombin, calcium chloride or its salts, thromboxane A2, adenosine triphosphate and arachidonate. 
     
     
         17 . The method of  claim 12  further comprising administering a compound selected from the group consisting of growth factors, cytokines, integrins, cadherins, molecules or drugs that promote angiogenesis, molecules or drugs that promote vasculogenesis, and molecules or drugs that promote arteriogenesis. 
     
     
         18 . The method of  claim 17  wherein the compound is selected from a group consisting of VEGF-A, PIGF, VEGF-B, VEGF-C, VEGF-D, TGF-β, Ang-1, Ang-2, IGF, HGF, FGF, Tie2, PDGF, CCL2, Alpha-V Beta-5, Alpha-5 Beta-1, VE-cadherin, PECAM-1, plasminogen activator, nitrogen oxide synthase, and combinations thereof. 
     
     
         19 . The method of  claim 12  further comprising administering one or more growth factors before, during or after implanting the viable mesenchymal stem cells in the avascular zone. 
     
     
         20 . The method of  claim 19  wherein the one or more growth factor is selected from the group consisting of TGF-β, FGF, PDGF, and IGF.

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