Preparation of compositions to treat and treatment of osteoarthritis using adipose-derived stromal vascular fraction cells

Abstract

A method for preparing a treatment composition for treatment of osteoarthritis including un-cultured stromal vascular fraction cells from adipose tissue includes direct aspiration of material of a centrifugally-formed pellet phase including stromal vascular fraction cells from enzymatically-digested adipose tissue from an internal containment volume of a portable apparatus through an aspiration tube inserted into the pellet phase and into a fluid receptacle located outside of the internal containment volume. The treatment composition may be administered into or in the vicinity of a patient's joint to be treated for osteoarthritis.

What is claimed is: 
     
         1 . A method for preparing a treatment composition for treatment of osteoarthritis including un-cultured stromal vascular fraction cells from adipose tissue, the method comprising:
 direct aspiration of material of a centrifugally-formed pellet phase from an internal containment volume of a container of a portable apparatus, the material of the pellet phase including stromal vascular fraction cells from enzymatically-digested adipose tissue, the direct aspiration comprising aspiration of at least a majority of the material of the pellet phase through an aspiration tube inserted into the pellet phase and into a fluid receptacle in fluid communication with the aspiration tube and located outside of the container.   
     
     
         2 . A method according to  claim 1 , wherein the fluid receptacle is pre-loaded prior to the direct aspiration with dispersion medium that mixes with the pellet phase material introduced into the fluid receptacle during the direct aspiration. 
     
     
         3 . A method according to  claim 2 , wherein the dispersion medium pre-loaded in the fluid receptacle has a volume in a range of from 1 milliliter to 10 milliliters. 
     
     
         4 . A method according to  claim 3 , wherein a volume ratio of the volume of the dispersion medium pre-loaded in the fluid receptacle to a volume of the pellet phase material introduced into the fluid receptacle during the direct aspiration is in a range of from 1:1 to 10:1. 
     
     
         5 . A method according to  claim 2 , wherein the dispersion medium comprises one or more than one member selected from the group consisting of saline solution, crystalloid solution, hyaluronic acid and hyaluronic acid-based materials. 
     
     
         6 . A method according to  claim 1 , wherein:
 during the direct aspiration, the portable apparatus is oriented in an access orientation;   the internal containment volume includes a pellet well located in a bottom portion of the internal containment volume and accessible only from above when the portable apparatus is in the access orientation;   during the direct aspiration, the at least a majority of the pellet phase material is aspirated from the pellet phase disposed in the pellet well with the aspiration tube inserted from above the pellet well into the pellet phase in the pellet well.   
     
     
         7 . A method according to  claim 6 , wherein during the direct aspiration, the aspiration tube is inserted into the internal containment volume from above the container and the aspiration tube extends downward through the internal containment volume into the pellet well. 
     
     
         8 . A method according to  claim 7 , wherein:
 the pellet well has a volume in a range of from 0.3 cubic centimeter to 3 cubic centimeters;   when the portable apparatus is in the access orientation, the pellet well has a vertical height dimension in a range of from 1 centimeter to 10 centimeters;   when the portable apparatus is in the access orientation, the pellet well has at least one portion with a vertical length of 1 centimeter, a maximum horizontal dimension along the vertical length of no larger than 5 millimeters and a minimum horizontal dimension along the vertical length of no smaller than 1.5 millimeters; and   during the direct aspiration, the aspiration tube extends into a said portion of the pellet well.   
     
     
         9 . A method according to  claim 8 , wherein:
 the portable apparatus comprises a filter disposed within the internal containment volume and wherein the internal containment volume includes a tissue retention volume on one side of the filter and a filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter and with the pellet well disposed in a bottom portion of the filtrate volume;   during the direct aspiration the aspiration tube passes through the tissue retention volume and the filtrate volume and pierces the filter.   
     
     
         10 . A method according to  claim 9 , wherein;
 the internal containment volume includes a first tapered portion below a bottom elevation of the filter and above the pellet well when the portable apparatus is in the access orientation, the first tapered portion being defined at least in part by a first internal wall surface at a first angle relative to horizontal when the apparatus is in the access orientation in a range of from 20° to 65°;   the internal containment volume includes a second tapered portion in the pellet well below the first tapered portion, wherein the second tapered portion is defined at least in part by a second internal wall surface having a second angle relative to horizontal when the apparatus is in the access orientation in a range of from 70° to 89°;   the internal containment volume includes an available processing volume with a portion of the available processing volume disposed in the tissue retention volume and another portion of the available processing volume in the filtrate volume; and   the second tapered portion of the internal containment volume in the pellet well has a volume in a range of from 0.2 percent to 2.5 percent of the portion of the available processing volume in the tissue retention volume.   
     
     
         11 . A method according to  claim 10 , wherein the available processing volume is in a range of from 75 cubic centimeters to 1300 cubic centimeters. 
     
     
         12 . A method according to  claim 9 , wherein the portable apparatus comprises a tissue collector disposed in the tissue retention volume and rotatable relative to the container in at least a first direction of rotation about an axis of rotation of a rotatable shaft, the tissue collector including at least one toothed member that sweeps through a portion of the tissue retention volume when the tissue collector is rotated in the first direction, the toothed member being configured with a plurality of teeth to collect and retain stringy tissue when the tissue collector is rotated in the first direction in contact with human biological material containing stringy tissue disposed in the tissue retention volume. 
     
     
         13 . A method according to  claim 1 , comprising prior to the direct aspiration:
 washing adipose tissue within the container to remove contaminants from the adipose tissue;   after the washing, digesting adipose tissue within the container, the digesting adipose tissue comprising adding to the container a volume of enzyme-containing digestion medium to contact washed adipose tissue in the container;   after permitting enzymatic digestion in the container for a retention time following adding the digestion medium, disposing the container in a centrifuge and centrifuging the container in the centrifuge to form density-separated phases within the container, the density-separated phases including the pellet phase; and   inserting the aspiration tube from outside of to inside of the container to contact the pellet phase in the internal containment volume within the container.   
     
     
         14 . A method for treating a patient for osteoarthritis of a joint, the method comprising:
 preparing a treatment composition according to the method of  claim 1 , wherein the treatment composition comprises material of the pellet phase dispersed in a dispersion medium;   administering into the joint or to a vicinity of the joint an administration volume of the treatment composition, wherein the administration volume is in a range of from 0.5 milliliter to 5 milliliters and includes from 0.25 millimeter to 2.5 milliliters of the pellet phase material dispersed in the dispersion medium.   
     
     
         15 . A method according to  claim 14 , wherein the administering comprises injecting the treatment composition into the joint or to the vicinity of the joint from the fluid receptacle into which the pellet phase material is introduced during the direct aspiration. 
     
     
         16 . A method according to  claim 15 , wherein the dispersion medium of the treatment composition comprises dispersion medium pre-loaded into the fluid receptacle prior to the direct aspiration. 
     
     
         17 . A method according to  claim 15 , wherein the dispersion medium comprises one or more than one member selected from the group consisting of saline solution, crystalloid solution, hyaluronic acid and hyaluronic acid-based materials. 
     
     
         18 . A method according to  claim 14 , wherein:
 during the direct aspiration, the portable apparatus is oriented in an access orientation;   the internal containment volume includes a pellet well located in a bottom portion of the internal containment volume and accessible only from above when the portable apparatus is in the access orientation; and   during the direct aspiration, the at least a majority of the pellet phase material is aspirated from the pellet phase disposed in the pellet well with the aspiration tube inserted from above the pellet well into the pellet phase in the pellet well.   
     
     
         19 . A method according to  claim 18 , wherein the portable apparatus comprises a filter disposed within the internal containment volume and wherein the internal containment volume includes a tissue retention volume on one side of the filter and a filtrate volume on another side of the filter with the tissue retention volume and the filtrate volume being in fluid communication through the filter and with the pellet well disposed in a bottom portion of the filtrate volume;
 the internal containment volume includes a first tapered portion below a bottom elevation of the filter and above the pellet well when the portable apparatus is in the access orientation, the first tapered portion being defined at least in part by a first internal wall surface at a first angle relative to horizontal when the apparatus is in the access orientation in a range of from 20° to 65°;   the internal containment volume includes a second tapered portion in the pellet well below the first tapered portion, wherein the second tapered portion is defined at least in part by a second internal wall surface having a second angle relative to horizontal when the apparatus is in the access orientation in a range of from 70° to 89°;   the internal containment volume includes an available processing volume with a portion of the available processing volume disposed in the tissue retention volume and another portion of the available processing volume in the filtrate volume; and   the second tapered portion of the internal containment volume in the pellet well has a volume in a range of from 0.2 percent to 2.5 percent of the portion of the available processing volume in the tissue retention volume.   
     
     
         20 . A method according to  claim 19 , wherein during the direct aspiration the aspiration tube is inserted into the internal containment volume from above and passes through the tissue retention volume and the filtrate volume and pierces the filter.