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ASCs · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ASCs | EXPERIMENTAL | - |
| ASCs+fibrin glue | EXPERIMENTAL | - |
| Fibrin glue | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ASCs (Cx401, company code) | DRUG | Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then. Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then. |
| Fibrin adhesive | DRUG | Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then. |
Inclusion Criteria: 1. Patient with a complex perianal fistula. A complex perianal fistula must meet one of the following: * No fistula tract is palpated under the perianal skin or tract parallel to the rectum on examination with a stylet. * Associated anal incontinence in transsphincteric f...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE4 | Undisclosed |
| Medtronic Plc | MDT | 1 | PHASE4 | IN.PACT AV Drug Coated Balloon - Primary Cohort, IN.PACT AV Drug Coated Balloon - Extended Cohort |
ASCs are used to treat complex perianal fistulas not associated with Crohn's disease. The therapy is being developed as a treatment for anal fistula, a condition involving an abnormal tract between the anal canal and the perianal skin. ASCs are administered to promote healing and closure of the fistula tract.
ASCs, or adipose-derived stem cells, are a cell-based therapy that targets the local inflammatory and tissue repair processes in anal fistula. The stem cells are derived from adipose tissue and are intended to modulate the immune response and promote tissue regeneration at the fistula site, aiding in closure and healing.
ASCs are being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company headquartered in Japan. Takeda's stock is traded under the ticker symbol TAK on the New York Stock Exchange. The company is conducting clinical development of ASCs for the treatment of anal fistula.
ASCs are in Phase 3 clinical development for the treatment of anal fistula. The therapy is investigational and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate the efficacy and safety of ASCs in patients with complex perianal fistulas not associated with Crohn's disease.
ASCs have been studied in one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT00475410. The trial, titled 'Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease,' enrolled 214 participants across Germany, Spain, and the United Kingdom. The study was randomized, double-blind, and active-controlled.
Yes, ASCs is an abbreviation for adipose-derived stem cells. In the context of this therapy, ASCs refer to stem cells derived from adipose tissue that are being investigated for the treatment of anal fistula. The clinical trial NCT00475410 specifically evaluates the efficacy and safety of adipose stem cells for complex perianal fistulas.