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Method and composition for treating inflammatory bowel disease without colectomy

一种组合物、结肠的技术，应用在药物组合、人体管状结构的装置、医药配方等方向，能够解决没有描述下肠道组织治疗或再生、不能特异性治疗等问题

Inactive Publication Date: 2016-02-24
REGENTYS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, many of these scaffolds are derived from non-human tissues, none have been described for the treatment or regeneration of lower intestinal tissues such as colon tissue, and are not specific for the treatment of UC

Method used

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  • Method and composition for treating inflammatory bowel disease without colectomy

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Experimental program
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Embodiment approach

[0064] Therefore, one embodiment of the method of the present invention comprises the following steps:

[0065] TS-ECM scaffolds were prepared using tissues selected from the group consisting of: lower intestinal tract, genitalia (except vagina), skin, pancreas, kidney, circulatory tissue, and respiratory tissue; and

[0066] The TS-ECM scaffolds are implanted, transplanted or administered into tissue of patients suffering from diseases or conditions affecting the same lower intestinal tract, genitals (except vagina), skin, pancreas, kidney, lower intestinal tract, circulatory tissue and respiratory tissue.

[0067] Optionally, when treating the colon, the method may further comprise one or more additional steps: (3) creating an ileal incision; and (4) providing the patient with total parenteral nutrition (TPN) via the patient's intravenous feeding while New mucous membranes are formed.

[0068] In a preferred embodiment, the method comprises treating damaged or diseased colo...

Embodiment 1

[0090] Example 1 - Surgical placement of solid ECM for colon tissue replacement

[0091] Small intestinal submucosa extracellular matrix (SIS-ECM) grafts were transplanted into the colon tissue of four (4) live dogs. SIS-ECM grafts of approximately 3-4 cm length were prepared according to known techniques. Grafts were prepared with different numbers of layers - 2-, 4-, 6-, and 8-layer sheets or tubes, and tested for transanal peripheral mucosal resection described below.

[0092] Four (4) healthy adult mongrel female dogs (approximately 20 kg body weight) underwent circumferential colonic mucosal EMR. After the dogs were anesthetized, surgical mucosectomy was performed. Alternatively, mucosal tissue ablation (eg, EMR) can be performed, eg, with a therapeutic endoscope (EG-3430, Pentax Medical, Montvale, NJ) and a commercially available kit (EMRKit, Olympus America, Center Valley, Pa). Fragmentary mucosal resections were performed sequentially until a 4-cm circumferential ...

Embodiment 2

[0110] Example 2 - Application of Gel ECM for Colon Tissue Replacement

[0111] According to the present invention, the feasibility of using an ECM gel composition for the treatment of inflammatory bowel disease (IBD) can be tested in vivo in rats. The rat can be established as a model for human IBD such as ulcerative colitis (UC), whereby UC can be induced in rat colon tissue by administration of dextran sodium sulfate (DSS) in drinking water ad libitum for several days .

[0112] Acute UC can be induced in rats by administering 2% DSS in drinking water provided ad libitum for seven days, followed by a saline flush. Chronic UC can be induced in rats by administering 2% DSS in drinking water provided ad libitum for one or more consecutive 7-day periods, followed by regular water.

[0113] UC can be treated with a gelatinous extracellular matrix (ECM) derived from the small intestinal submucosa (SIS) and introduced into the colon via an enema. The gel SIS-ECM may be administ...

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Abstract

Methods and compositions for treating diseased or damaged tissue, such as Inflammatory Bowel Disease, e.g., Ulcerative Colitis, include tissue regeneration using stem cells or tissue grafts which stimulate stem cell migration to the damaged tissue. The tissue grafts can be extracellular matrix (ECM) material, such as tissue-specific extracellular matrix (TS-ECM). The methods can also include mucosal resection of the damaged or diseased tissue prior to placement of the graft.

Description

Background technique [0001] Inflammatory bowel disease (IBD), consisting of two separate diseases: Crohn's disease (CD) and ulcerative colitis (UC), affects 833,000 Americans. [0002] While CD can appear anywhere along the alimentary canal (from mouth to anus) and usually affects the entire thickness of the alimentary canal wall, UC is limited to the colon and rectum and affects only the mucosa (inner layer) of the wall. [0003] Medical treatment, including the use of anti-inflammatory drugs that can have serious side effects, may not treat the symptoms of UC, and complete removal of the colon (colectomy) is the only known option when the patient is refractory to all other medical treatments. "Cure Therapy" in UC. Colectomy is a well-known and major surgical procedure that usually requires an incision of the ileum to facilitate waste removal. [0004] Alternatives to first line therapy (drug therapy with potentially deleterious side effects) and second line therapy (colect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/04A61F2/00A61K35/12A61L27/38A61L27/40
CPCA61L27/3834A61L27/3629A61L27/3633A61P1/00A61P1/04A61P35/00A61K35/28A61B17/3205A61L27/3679A61L27/52
Inventor 马克·拉墨尔斯蒂芬·F·巴迪拉克蒂莫西·基恩
Owner REGENTYS CORP
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