System and method for delivering umbilical cord-derived tissue-matched stem cells for transplantation

• US 20020132343A1
• Filed: 03/06/2002
• Published: 09/19/2002
• Est. Priority Date: 03/19/2001
• Status: Abandoned Application

• Current Assignee: BioStar, Inc. (Thermo Fisher Scientific Incorporated)
• Original Assignee: BioStar, Inc. (Thermo Fisher Scientific Incorporated)
• Inventors: Lum, Clark
• Application Number:
  US10/090,632
• Publication Number:
  US 20020132343A1
• Time in Patent Office: Days
• US Class Current: 435/372
• CPC Class Codes: A61K 2035/124 the cells being hematopoietic, bone marrow derived or blood cells
• CPC Class Codes: C12N 2500/25 Insulin-transferrin; Insulin-transferrin-selenium
• CPC Class Codes: C12N 2500/90 Serum-free medium, which may still contain naturally-sourced components
• CPC Class Codes: C12N 2501/125 Stem cell factor [SCF], c-kit ligand [KL]
• CPC Class Codes: C12N 2501/145 Thrombopoietin [TPO]
• CPC Class Codes: C12N 2501/23 Interleukins [IL]
• CPC Class Codes: C12N 2501/26 Flt-3 ligand (CD135L, flk-2 ligand)
• CPC Class Codes: C12N 5/0647 Haematopoietic stem cells; Uncommitted or multipotent progenitors

Abstract

The present invention relates to cord blood stem cell systems, methods, and products for delivering tissue-matched stem cells derived from a single cord blood source, for use in transplantation. The cord blood stem cell system standardizes, customizes and integrates cord blood-derived stem cell expansion to produce progenitor cells to treat hematological and other diseases. The system integrates the production of patient-matched stem cells so that the patient'"'"'s physician may order the biological product and receive customized cord blood-derived stem cells as an approved biologic ready for transplantation and capable of long term engraftment.

Claims

1. A stem cell manufacturing system for delivering tissue-matched stem cells, the system comprising:

a delivery system for delivering a biological product comprised of tissue-matched stem cells and a stem cell expansion system that produces a biological product, said stem cell expansion system being coupled to the delivery system.

2. The stem cell manufacturing system of claim 1 wherein said delivery system receives the patient order.

3. The stem cell manufacturing system of claim 1 wherein said delivery system identifies a suitable source of donor blood.

4. The stem cell manufacturing system of claim 3, wherein said donor blood is umbilical cord blood.

5. The stem cell manufacturing system of claim 1, wherein the tissue-matched stem cells are CD34+ cells.

6. The stem cell manufacturing system of claim 1, wherein the tissue-matched stem cells are matched by HLA loci, said HLA loci selected from the group consisting of, HLA-A, HLA-B, and HLA-DR.

7. The stem cell manufacturing system of claim 1, wherein the tissue-matched stem cells are CFU-GM cells.

8. The stem cell manufacturing system of claim 1, wherein said biological product is licensed.

9. The stem cell manufacturing system of claim 1, wherein said delivery system is conducted at a licensed establishment.

10. The stem cell manufacturing system of claim 1, wherein said stem cell expansion system is conducted at a licensed establishment.

11. The stem cell manufacturing system of claim 1, wherein said delivery system and stem cell expansion system are conducted at the same licensed establishment.

12. The stem cell manufacturing system of claim 1, wherein said biological product is ready for administration to the patient.

13. The stem cell manufacturing system of claim 1, wherein said tissue-matched stem cells are CD34+ cells that have been expanded more than 200-fold.

14. The stem cell manufacturing system of claim 1, wherein the tissue-matched stem cells are matched using methods selected from the group consisting of:

DNA-based testing methods and low resolution/split antigen level.

15. The manufacturing system of claim 14, wherein said matching is HLA loci matching using methods selected from the group consisting of:

DNA-based testing methods and low resolution/split antigen level.

16. The manufacturing system of claim 15, wherein the tissue-matched stem cells possess at least three HLA loci identical to the HLA loci of the patient order.