Granted Patent
B2
US 12,653,926 · App. 17/692,530 · Granted Jun 16, 2026
Extracellular matrix-derived gels and related methods
A61L27/3633A61K35/12A61L27/34A61L27/3687A61L27/38A61L27/52A61L27/54C12P21/06A61K38/00A61L2300/64A61L2400/06A61L2420/04
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Abstract
Provided are methods for preparing gelled, solubilized extracellular matrix (ECM) compositions useful as cell growth scaffolds. Also provided are compositions prepared according to the methods as well as uses for the compositions. In one embodiment a device, such as a prosthesis, is provided which comprises an inorganic matrix into which the gelled, solubilized ECM is dispersed to facilitate in-growth of cells into the ECM and thus adaptation and/or attachment of the device to a patient.
Claims (20)
1 . A method of preparing an extracellular matrix-derived gel comprising: (i) providing an acidic extracellular matrix (ECM) digest solution comprising solubilized extracellular matrix digested with an acid protease, wherein the extracellular matrix has not been dialyzed, (ii) providing a neutralizing solution comprising a base and/or buffer capable of bringing the acidic ECM digest solution to physiological pH; (iii) mixing the acidic ECM digest solution with the neutralizing solution to produce a neutralized digest solution, and (iv) gelling the neutralized digest solution at a temperature greater than 25° C.
2 . The method of claim 1 , wherein the extracellular matrix in the ECM digest solution has not been subjected to a cross-linking process.
3 . The method of claim 1 , wherein the extracellular matrix is derived from mammalian tissue.
4 . The method of claim 3 , wherein the mammalian tissue is derived from one of urinary bladder, spleen, liver, heart, pancreas, ovary, or small intestine.
5 . The method of claim 3 , wherein the mammalian tissue is derived from a pig, cow, or sheep.
6 . The method of claim 1 , wherein the extracellular matrix comprises urinary bladder matrix (UBM) or small intestinal submucosa (SIS).
7 . The method of claim 1 , wherein the acidic ECM digest solution and the neutralizing solution is maintained at or below 25° C. before mixing.
8 . The method of claim 1 , wherein the acidic ECM digest solution comprises an acid protease.
9 . The method of claim 8 , wherein the protease is pepsin.
10 . The method of claim 9 , wherein the pH of the acidic ECM digest solution is between 2 and 4.
11 . The method of claim 9 , wherein the protease is trypsin.
12 . The method of claim 1 , wherein the neutralizing solution comprises a base.
13 . The method of claim 12 , wherein the base comprises a hydroxyl ion and/or is NaOH.
14 . The method of claim 1 , wherein the neutralized digest solution has a pH of about 7.2 to about 7.8.
15 . The method of claim 1 , wherein the neutralized digest solution comprises an isotonic buffered solution.
16 . The method of claim 1 , wherein the neutralized digest solution comprises a physiological ionic strength.
17 . The method of claim 1 , wherein mixing the acidic ECM digest solution with the neutralizing solution to form a neutralized digest solution occurs during administration at a desired site in a human subject.
18 . The method of claim 1 , wherein mixing the acidic ECM digest solution with the neutralizing solution to form a neutralized digest solution occurs prior to administration to a subject.
19 . The method of claim 17 , wherein gelling the neutralized digest solution occurs at physiological temperature in the human subject.
20 . The method of claim 19 , wherein the gelling occurs at 37° C.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 11, 2022
From: BADYLAK, STEPHEN F.; FREYTES, DONALD
To: UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 059239/0039 →
Continuity (7)
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