Placental Membrane Preparations and Methods of Making and Using Same for Regenerating Cartilage and Spinal Intervertebral Discs

Abstract

A method for treating cartilage defects including providing a placental membrane preparation that comprises ground or minced placental membranes and optionally, a ground or minced cartilage and/or biocompatible glue, and introducing the preparation to a cartilage defect within a skeletal joint. The cartilage defect may comprise a hyaline cartilage defect, such as a chondral defect, or meniscal defect. The treatment may be provided in combination with other treatments such as marrow stimulation treatments and surgical repair treatments using sutures or other fixation techniques. The preparation promotes the regeneration of cartilage within the skeletal joint.

What is claimed is: 
     
         1 . A method of generating cartilage in vivo in a skeletal joint comprising,
 applying a preparation to a cartilage defect,   wherein the preparation comprises a placental membrane material selected from the group consisting of a ground placental membrane, a minced placental membrane and combinations thereof.   
     
     
         2 . The method according to  claim 1  wherein the preparation comprises a processed cartilage selected from the group consisting of a ground cartilage, a minced cartilage, a cartilage paste and combinations thereof. 
     
     
         3 . The method according to  claim 2  wherein the processed cartilage is selected from the group consisting of an autograft cartilage, an allograft cartilage and combinations thereof. 
     
     
         4 . The method according to  claim 1  wherein the preparation comprises hyaluronic acid, saline or a combination thereof. 
     
     
         5 . The method according to  claim 1  wherein the preparation comprises a biocompatible glue. 
     
     
         6 . The method according to  claim 1  wherein the preparation comprises amniotic fluid cells. 
     
     
         7 . The method according to  claim 1  wherein the preparation excludes a synthetic matrix material, in vitro cultured cells or a combination thereof. 
     
     
         8 . The method according to  claim 1  wherein the placental membrane material comprises amnion tissue comprising organized amniotic extracellular matrix (ECM), amniotic tissue cells and growth factors contained within the ECM and amniotic tissue cells. 
     
     
         9 . The method according to  claim 8  wherein the ECM comprises amnion-derived collagen, fibronectin, laminin, proteoglycans and glycosaminoglycans. 
     
     
         10 . The method according to  claim 9  wherein the amnion-derived collagen is derived from an epithelium layer, a basement membrane layer, a compact layer, a fibroblast layer, an intermediate layer and a spongy layer of the amnion tissue. 
     
     
         11 . The method according to  claim 1  wherein the placental membrane material comprises intact placental membrane portions. 
     
     
         12 . The method according to  claim 11  wherein the intact placental membrane portions comprise sessile epithelial cells and sessile mesenchymal cells that are native to the placental membrane intact placental membrane portions. 
     
     
         13 . The method according to  claim 1  wherein the cartilage defect is selected from the group consisting of a hyaline articular cartilage defect, a meniscus cartilage defect, and an intervertebral disc defect. 
     
     
         14 . The method according to  claim 1  wherein the preparation is injected into a joint capsule of the skeletal joint after performing a marrow stimulation procedure to stimulate the development of a reparative cartilage in the skeletal joint. 
     
     
         15 . The method according to  claim 14  further comprising, following injecting the preparation into the joint capsule, evaluating the amount of in vivo cartilage generation within the skeletal joint, and based thereon, determining whether additional injections of the preparation into the joint capsule are desired for accomplishing a desired amount of in vivo cartilage generation within the skeletal joint. 
     
     
         16 . The method according to  claim 1  further comprising causing blood to accumulate within the cartilage defect. 
     
     
         17 . The method according to  claim 16 , wherein the preparation is applied to the cartilage defect following accumulation of the blood within the cartilage defect. 
     
     
         18 . The method according to  claim 1  further comprising performing a marrow stimulation technique in the skeletal joint. 
     
     
         19 . The method according to  claim 1  wherein the preparation promotes the in vivo generation of hyaline cartilage within the skeletal joint. 
     
     
         20 . The method according to  claim 1  wherein the preparation promotes the in vivo generation of fibrocartilage within the skeletal joint. 
     
     
         21 . The method according to  claim 1  wherein the preparation promotes the regeneration of cartilage in the cartilage defect in the absence of in vitro cultured cells. 
     
     
         22 . The method according to  claim 1  further comprising removing diseased cartilage from the skeletal joint thereby forming a void into which the preparation is introduced. 
     
     
         23 . The method according to  claim 22  wherein substantially all of a healthy cartilage in the skeletal joint remains in the skeletal joint after the diseased cartilage is removed. 
     
     
         24 . The method according to  claim 1  wherein a plurality of cells contained within and native to the placental membrane material chondrogenically differentiate in vivo within the cartilage defect. 
     
     
         25 . The method according to  claim 24  wherein the plurality of cells comprise mesenchymal cells. 
     
     
         26 . The method according to  claim 1  wherein the placental membrane material comprises sessile cells that are native to the placental membrane sheet. 
     
     
         27 . The method according to  claim 26  further comprising in vivo chondrogenic differentiation of the sessile cells. 
     
     
         28 . A method of generating cartilage in vivo in a skeletal joint comprising,
 identifying diseased cartilage in the skeletal joint,   removing at least a portion of the diseased cartilage thereby forming a void,   performing a marrow stimulation procedure within the skeletal joint and thereby causing blood to accumulate within the void, and   inserting a preparation into the void, the preparation including a minced placental membrane exhibiting an average placental membrane particle size within a range of about 0.1 mm to about 3 mm, the minced placental membrane comprising amnion tissue containing organized amniotic extracellular matrix (ECM), sessile amnion tissue cells that are native to the placental membrane, growth factors contained within the ECM and sessile amnion tissue cells, and sessile amnion tissue-derived collagen, fibronectin, laminin, proteoglycans and glycosaminoglycans, wherein the sessile amnion tissue-derived collagen is derived from an epithelium layer, a basement membrane layer, a compact layer, a fibroblast layer, an intermediate layer and a spongy layer of the sessile amnion tissue,   wherein a portion of the sessile amnion tissue cells chondrogenically differentiate in vivo within the void.   
     
     
         29 . The method according to  claim 28  wherein the preparation comprises amniotic fluid cells. 
     
     
         30 . The method according to  claim 28  wherein the preparation excludes in vitro cultured cells. 
     
     
         31 . The method according to  claim 28  further comprising mincing an intact placental membrane to produce the minced placental membrane. 
     
     
         32 . A method of generating cartilage in vivo in a skeletal joint comprising,
 applying a preparation to cartilage in the skeletal joint, the preparation comprising amniotic fluid cells and placental membrane portions comprising sessile amnion tissue cells that are native to the placental membrane portions, and   differentiating the sessile amnion tissue cells into chondrocytes in vivo within the skeletal joint.   
     
     
         33 . The method according to  claim 32  comprising identifying diseased cartilage in the skeletal joint, removing at least a portion of the diseased cartilage thereby forming a void, performing a marrow stimulation procedure within the skeletal joint and thereby causing blood to accumulate within the void and inserting the preparation into the void.