Claims for Patent: 10,014,079

Summary for Patent: 10,014,079

Title:	Business method for collection, processing, cryogenic storage and distribution of a biologic sample material
Abstract:	Methods and systems for collection, processing, cryogenic storage and distribution of a stem cell based biological sample material.
Inventor(s):	Dudzinski; Anthony (Middletown, NJ), Neill; Christopher J. (New Brunswick, NJ), Arnone; John S. (Shrewsbury, NJ)
Assignee:	American Cryostem Corporation (Eatontown, NJ)
Application Number:	13/702,304
Patent Claims:	1. A method for collection, processing, cryogenic storage and distribution of a biological sample material comprising the steps of: a. coordinating the collection of a biological sample of a client comprising supplying a collection system comprising a plurality of components for collection and transportation of the biological sample; b. obtaining the biological sample from a client by standard medical practice removal techniques; c. transporting the biological sample in the collection system to a processing facility wherein the collections system comprises (a) identification material for the obtained biological sample (b) coded labels for use with an encoded program, (c) client sample bags, (d) transportation box and (e) transportation labeling; d. introducing information from the collection system to a processing module of a database having an encoded program, wherein the encoded program of the database is capable to automatically route new or changing information introduced into the database; e. processing the biological sample, wherein the biological sample is disassociated to separate and isolate material for cryopreservation by enzymatic digestion; f. testing for quality control of the isolated material for cryopreservation; g. cryopreserving the isolated material in a freezing apparatus; h. selecting outside facilities for storage of the isolated cryopreserved material; i. storing the cryopreserved isolated material in a liquid nitrogen tank having the ability to have alternate power sources; and k. separating from the isolated material at least three (3) test samples into vials after step (f) for quality and viability testing; l. preparing a certificate of analysis based on the testing in step f; m. (i) distributing the cryopreserved isolated material as directed by a client; and (ii) distributing (1) one of the at least three (3) test samples to a processing facility for quality control testing upon receipt at the processing facility to confirm viability of the cryopreserved isolated material distributed as directed by a client after step j; wherein the client sample bags include a medium comprising human serum which is free of animal albumin and animal serum which will support the survival of the cells of the biological sample; wherein the biological sample is washed with an antibiotic during processing; wherein the collection system components are introduced to a processing module of the database via a log-in port, by scanning a barcode on the client sample bag; wherein the obtained biological sample is an adipose tissue sample; wherein the isolated material is a stromal vascular fraction consisting essentially of a mixture of pre-adipocytes, adipose-derived mesenchymal stem cells, microvascular endothelial cells, endothelial progenitor cells, and monocytes having less than one (1) percent antibiotic; wherein the business method is adapted to process at least 35 cubic centimeters of the adipose tissue into the stromal vascular fraction of at least 1.5 million cells; wherein at least 50 percent of the stromal vascular fraction of at least 1.5 million cells are viable; and wherein each cell of the stromal vascular fraction of at least 1.5 million cells are between 6.0 and 15.0 microns. 2. The method of claim 1, wherein distributing the isolated material is to at least one of (i) client from which biological sample was obtained, (ii) research group or (iii) entity from which biological sample was not obtained. 3. A method for collection, processing, cryogenic storage and distribution of an autologous stem cell biological sample material derived from adipose tissue comprising the steps of: a. coordinating the collection of the autologous stem cell biological sample material derived from adipose tissue of a client comprising supplying a collection system comprising a plurality of components for collection and transportation of the biological sample; b. obtaining an autologous stem cell biological sample material derived from adipose tissue from a client; c. transferring the autologous stem cell biological sample material derived from adipose tissue to a defined container having at least one port, wherein the container contains a medium comprising human serum which is free of animal albumin and animal serum which will support the survival of the cells of the biological sample; d. transporting the autologous stem cell biological sample material derived from adipose tissue in the collection system to a processing facility; e. introducing information from the collection system components to a processing module of a customized database having an encoded program, wherein the encoded program of the database is capable to automatically route new or changing information introduced into the database; f. processing the autologous stem cell biological sample material derived from adipose tissue, wherein the autologous stem cell biological sample material derived from adipose tissue is disassociated to separate and isolate material for cryopreservation; g. testing for quality control of the autologous isolated material for cryopreservation; h. cryopreserving the autologous isolated material in a freezing device; i. selecting facilities for storage of the autologous isolated cryopreserved material; j. storing the cryopreserved autologous isolated material in the selected facility in a liquid nitrogen tank having the ability to have alternate power sources; and k. distributing the cryopreserved isolated material designated by a client; wherein the autologous isolated material is a stromal vascular fraction consisting essentially of a mixture of pre-adipocytes, adipose-derived mesenchymal stem cells, microvascular endothelial cells, endothelial progenitor cells, and monocytes; wherein the method is adapted to process at least 35 cubic centimeters of the adipose tissue into a stromal vascular fraction of at least 1.5 million cells; wherein steps b. through j. are under Good Manufacturing Practices; wherein the autologous isolated material has not contacted non-human serum; wherein at least 50 percent of the stromal vascular fraction of at least 1.5 million cells are viable; wherein each cell of the stromal vascular fraction of at least 1.5 million cells are between 6.0 and 15.0 microns. 4. The method of claim 1, wherein disassociation by enzymatic digestion comprises a combination of collagenase and neutral protease to define yield amounts and cell viability.

Details for Patent 10,014,079

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2030-06-07