Cytotherapeutics, cytotherapeutic units and methods for treatments using them

• US 8,617,535 B2
• Filed: 11/03/2006
• Issued: 12/31/2013
• Est. Priority Date: 11/26/2002
• Status: Active Grant

• Current Assignee: Celularity, Inc.
• Original Assignee: Anthrogenesis Corporation (Bristol-Myers Squibb Company)
• Inventors: Hariri, Robert J.
• Primary Examiner(s): HIBBERT, CATHERINE S
• Application Number:
  US11/592,544
• Publication Number:
  US 20070092497A1
• Time in Patent Office: 2,615 Days
• Field of Search: None
• US Class Current: 424/93.3
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 35/51 Umbilical cord; Umbilical cord blood; Umbilical stem cells
• CPC Class Codes: A61K 35/54 Ovaries; Ova; Ovules; Embryos; Foetal cells; Germ cells
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 15/14 for lactation disorders, e.g. galactorrhoea
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/06 Antianaemics

Abstract

The present invention provides cytotherapeutic units comprising predetermined numbers of selected types of potent cells. Assurance of the nature and identities of such cells is achieved through assay and certification of said numbers and identities. Therapeutic modalities are provided. Libraries of cell preparations with assayed and preferably certified populations are preferred and the preparation of cell preparations tailored to specific patients or disease states are provided.

Claims

1. A kit comprising a cytotherapeutic unit suitable for treatment of a patient in need of hematopoietic cells, said cytotherapeutic unit comprising at least 1% CD34⁺ cells within a plurality of potent cells, said cytotherapeutic unit comprising cells from a plurality of sources, wherein said plurality of potent cells comprises isolated cells that are CD34⁻

, OCT-4⁺, SSEA3⁻

, CD10⁺, CD29⁺, CD38⁻

, CD44⁺, CD45⁻

, CD54⁺, CD90⁺, SH2⁺, SH3⁺, SH4⁺, SSEA4⁻

, and ABC-p⁺, and wherein one of said plurality of sources is postpartum placental perfusate.

2. The kit of claim 1 wherein said cytotherapeutic unit comprises potent cells obtained from fetal cord blood.

3. The kit of claim 1 wherein said potent cells are obtained from at least two individuals.

4. The kit of claim 1 wherein said potent cells are obtained from at least five individuals.

5. The kit of claim 1 wherein at least one type of cell is excluded from the cytotherapeutic unit.

6. The kit of claim 1 wherein the plurality of potent cells is selected to render the cytotherapeutic unit suitable for therapy for an indicated disease state or condition.

7. The kit of claim 6 wherein at least one type of cell is excluded from the cytotherapeutic unit.

8. A kit comprising a cytotherapeutic unit suitable for the treatment of a patient in need of hematopoietic cells, said cytotherapeutic unit comprising potent cells, wherein at least 1% of said potent cells are CD34⁺, and wherein said cytotherapeutic unit comprises at least two preselected types of potent cells, said cytotherapeutic unit comprising cells from a plurality of sources, wherein at least one of the at least two preselected types of potent cells comprise isolated cells that are CD34−

, OCT-4⁺, SSEA3−

, CD10⁺, CD29⁺, CD38−

, CD44⁺, CD45−

, CD54⁺, CD90⁺, SH2⁺, SH3⁺, SH4⁺, SSEA4−

, and ABC-p⁺, and wherein one of said plurality of sources is postpartum placental perfusate.

9. The kit of claim 8, comprising a certification of the contents of said cytotherapeutic unit.

10. The kit of claim 9 wherein said certification comprises an indication of cells excluded from said cytotherapeutic unit.

11. The kit of claim 9 wherein said certification comprises an indication of cells absent from said cytotherapeutic unit.

12. The kit of claim 9, wherein said certification indicates how the presence, absence, and/or exclusion of certain cell types render or renders the cytotherapeutic unit suitable for therapy for an indicated disease state or condition.