IP Library › Patent Application 12781451
Patent Application
App. No. 12/781,451

METHOD FOR EX-VIVO EXPANSION OF REGULATORY T CELLS WITH ENHANCED SUPPRESSIVE FUNCTION FOR CLINICAL APPLICATION IN IMMUNE MEDIATED DISEASES

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Patent No.
US None
App. No.
12/781,451
Abstract

The invention provides methods for the ex-vivo expansion of CD4+CD25+ Tregs. The invention provides a method for producing ex vivo expanded Tregs that may be used to inhibit unwanted human immune responses against self-antigens or allergens. Additionally, the ex vivo expanded Tregs may provide treatment for inflammatory/automimmune diseases.

Claims (10)

1 . A method comprising: a) obtaining a population of T cells from an individual with an immune-mediated disease selected from Systemic Lupus Erythematous, Multiple Sclerosis, asthma, Rheumatoid Arthritis, Crohn's Disease, or Ulcerative Colitis; b) isolating and purifying from the T cell population a subpopulation of CD4+CD25+ Tregs; and c) expanding the Treg cells of the subpopulation, wherein the expanded Treg cells exhibit enhanced suppressive activity compared to a population of freshly purified, unexpanded Tregs from the individual.

2 . The method of claim 1 , wherein the expansion is between about 100 to 1,000 fold.

3 . The method of claim 1 , wherein the expansion was carried out for a period of about 3 weeks.

4 . A method of treating an individual with immune-mediated disease, the method comprising: a) obtaining a population of T cells from an individual with an immune-mediated disease selected from Systemic Lupus Erythematous, Multiple Sclerosis, asthma, Rheumatoid Arthritis, Crohn's Disease, or Ulcerative Colitis; b) isolating and purifying from the T cell population a subpopulation of CD4+CD25+ Tregs; c) expanding the Treg cells of the subpopulation; and d) administering a portion of the CD4+CD25+ regulatory T cells to a human being treated for the immune-mediated disease.

5 . The method of claim 4 , wherein the immune-mediated disease is Systemic Lupus Erythematous.

6 . The method of claim 4 , wherein the immune-mediated disease is Multiple Sclerosis.

7 . The method of claim 4 , wherein the immune-mediated disease is asthma, Rheumatoid Arthritis.

8 . The method of claim 4 , wherein the immune-mediated disease is Rheumatoid Arthritis.

9 . The method of claim 4 , wherein the immune-mediated disease is Crohn's Disease.

10 . The method of claim 4 , wherein the immune-mediated disease is Ulcerative Colitis.

Assignments (12)
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 036662, FRAME 0053 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065610/0503 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: THERAKOS, INC.
To: MALLINCKRODT CRITICAL CARE FINANCE INC.
Reel/Frame 038008/0824 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT IP
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 038009/0016 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT PHARMA IP TRADING DAC
To: MALLINCKRODT IP
Reel/Frame 038009/0058 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2016
From: MALLINCKRODT CRITICAL CARE FINANCE INC.
To: MALLINCKRODT PHARMA IP TRADING DAC
Reel/Frame 038038/0009 →
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY COLLATERAL AT REEL/FRAME NO. 29549/0074 Recorded Sep 25, 2015
From: ROYAL BANK OF CANADA
To: THERAKOS, INC.
Reel/Frame 036688/0833 →
SECURITY INTEREST Recorded Sep 25, 2015
From: THERAKOS, INC.
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 036662/0053 →
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY COLLATERAL AT REEL/FRAME NO. 29549/0119 Recorded Sep 25, 2015
From: ROYAL BANK OF CANADA
To: THERAKOS, INC.
Reel/Frame 036688/0863 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (FIRST LIEN) Recorded Dec 28, 2012
From: THERAKOS, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 029549/0074 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (SECOND LIEN) Recorded Dec 28, 2012
From: THERAKOS, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 029549/0119 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2012
From: LI, LILY
To: THERAKOS, INC.
Reel/Frame 029156/0403 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2012
From: CAO, TINGHUA
To: THERAKOS, INC.
Reel/Frame 029156/0534 →