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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...
ASCs is an investigational cell-based therapy being developed for the treatment of complex perianal fistulas not associated with Crohn's disease. It is designed to be administered to patients with anal fistula, a condition in which an abnormal tunnel forms between the anal canal and the skin near the anus.
ASCs is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating ASCs for complex perianal fistulas.
ASCs is in Phase 3 clinical development. The Phase 3 trial for ASCs has been completed. ASCs is not approved for any indication and remains an investigational therapy.
ASCs has been evaluated in a completed Phase 3 trial, NCT00475410, titled "Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn's Disease." The trial enrolled 214 patients across Germany, Spain, and the United Kingdom.
Yes, ASCs is also known by the company code Cx401. Both names refer to the same investigational therapy being developed by Takeda for complex perianal fistulas not associated with Crohn's disease.