Systems for isolating and using clinically safe adipose derived regenerative cells

• US 10,119,113 B2
• Filed: 10/12/2015
• Issued: 11/06/2018
• Est. Priority Date: 12/07/2001
• Status: Expired due to Fees

• Current Assignee: Lorem Vascular Pte. Ltd.
• Original Assignee: Cytori Therapeutics Incorporated
• Inventors: Hedrick, Marc H., Fraser, John K., Schulzki, Michael J., Byrnes, Bobby, Carlson, Grace, Schreiber, Ronda Elizabeth, Wulur, Isabella
• Primary Examiner(s): Lankford, Blaine
• Application Number:
  US14/880,891
• Publication Number:
  US 20160137970A1
• Time in Patent Office: 1,121 Days
• Field of Search: None
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: C12M 29/04 Filters; Permeable or porous membranes or plates, e.g. dialysis
• CPC Class Codes: C12M 45/00 Means for pre-treatment of biological substances
• CPC Class Codes: C12M 47/04 Cell isolation or sorting purging biological preparations of unwanted cells C12N5/0081, determining the presence or kind of microorganism C12Q1/04
• CPC Class Codes: C12N 5/0667 Adipose-derived stem cells [ADSC]; Adipose stromal stem cells

Abstract

Systems and methods are described that are used to separate cells from a wide variety of tissues. In particular, automated systems and methods are described that separate regenerative cells, e.g., stem and/or progenitor cells, from adipose tissue. The systems and methods described herein provide rapid and reliable methods of separating and concentrating regenerative cells suitable for re-infusion into a subject.

Claims

1. An automated system for separating and concentrating regenerative cells from tissue comprising:

a collection chamber, which is configured to receive;

(1) tissue removed from a subject; and

(2) disaggregation agents, such that said disaggregation agents may be added to said tissue in an aseptic manner, and configured to separate said regenerative cells from the tissue;

a processing chamber connected to the collection chamber to receive disaggregated tissue from the collection chamber, wherein the processing chamber is coupled to the collection chamber via a conduit;

a centrifugation device which can connect to the processing chamber, wherein the centrifugation device is configured to concentrate regenerative cells from the disaggregated tissue present in the processing chamber;

a programmable processing device capable of communication with and controlling the collection chamber, the processing chamber, the centrifugation device and associated connections; and

an optical sensor along the conduit leading out of the collection chamber.

2. The automated system of claim 1, wherein the processing chamber comprises one or more centrifuge chambers.

3. The automated system of claim 1, wherein the processing chamber is constructed of disposable material that meets biocompatibility requirements for intravascular contact as described in an ISO 10993 standard.

4. The automated system of claim 1, wherein the centrifuge device and the programmable processing device are re-usable.

5. The automated system of claim 1, wherein the collection chamber comprises one or more rigid canisters.

6. The automated system of claim 1, wherein the collection chamber comprises one or more flexible bags.

7. The automated system of claim 1, wherein the collection chamber is constructed of disposable material that meets biocompatibility requirements for intravascular contact as defined in an ISO 10993 standard.

8. The automated system of claim 1, comprising automated valves and pumps for collecting said tissue, wherein the processing device is configured to introduce a pre-programmed amount of a washing agent based on the volume of tissue.

9. The automated system of claim 1, further comprising a waste chamber.

10. The automated system of claim 1, wherein the processing device further comprises a user interface for a user to input parameters into the system.

11. The automated system of claim 1, wherein the processing device further comprises a display screen to display instructions that guide a user to input parameters, confirm pre-programmed steps, warn of errors, or combinations thereof.

12. The automated system of claim 1, wherein the collection chamber includes one or more ports for permitting a washing solution to be delivered to the interior of the chamber, and none or more ports for permitting waste and other materials to be directed out from the collection chamber.

13. The automated system of claim 1, wherein the collection chamber is constructed of biocompatible material that can be sterilized.

14. The automated system of claim 1, wherein the processing chamber is constructed of biocompatible material that can be sterilized.

15. The automated system of claim 1, wherein the optical sensor determines that effluent liquid from the tissue collection chamber is clear and devoid of unwanted material.

16. The automated system of claim 1, further comprising a pressure sensor.

17. The automated system of claim 1, further comprising a temperature control device.

18. The automated system of claim 1, further comprising a bar code reading system.

19. A method of separating and concentrating regenerative cells from adipose tissue comprising introducing adipose tissue into the system of claim 1, and processing said adipose tissue so as to obtain a concentrated population of regenerative cells.

20. The method of claim 17, further comprising cryopreserving at least a portion of the separated and concentrated regenerative cells.