Darvadstrocel

Overview

Darvadstrocel is a suspension of expanded human allogeneic adipose-derived mesenchymal stem cells extracted from the subdermal adipose tissue of healthy donors via liposuction. Darvadstrocel was first approved by the European Commission on March 23, 2018, under the brand name Alofisel. It is indicated for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn’s disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy. It is the first mesenchymal stem cell therapy approved in Europe for this therapeutic indication. Perianal fistula is a common manifestation of Crohn’s disease and is often difficult to manage, as it may be associated with complex presentations and symptoms. Darvadstrocel exhibits immunomodulatory and anti-inflammatory effects: it aims to reduce local inflammation and enhance tissue repair in perianal fistulas.

Indication

Darvadstrocel is indicated for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Darvadstrocel should be used only after conditioning of the fistulas.

Associated Conditions

Complex Perianal Fistula

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells	2023/08/03	NCT05974280	N/A	Recruiting	Nantes University Hospital
Darvadstrocel for Crohn's Fistula in the Realworld	2023/02/23	NCT05742100	N/A	Completed	Dolores Herreros Marcos
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease	2022/04/11	NCT05322057	N/A	Completed	Medical University of Vienna
A Survey of Darvadstrocel in People with Crohn's Disease	2021/11/09	NCT05113095	N/A	Recruiting	Takeda
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease	2021/01/08	NCT04701411	Phase 3	Terminated	Takeda
A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula	2019/10/08	NCT04118088	Phase 4	Terminated	Takeda
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula	2019/09/03	NCT04075825	Phase 3	Completed	Takeda
Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)	2017/09/12	NCT03279081	Phase 3	Completed	Tigenix S.A.U.
Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.	2011/06/14	NCT01372969	Phase 1	Completed	Tigenix S.A.U.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Alofisel	Takeda Pharma A/S,Delta Park 45,2665 Vallensbaek Strand,Denmark	Withdrawn	3/23/2018

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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