Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex

perianal The anus ( Latin, 'ring' or 'circle') is an opening at the opposite end of an animal's digestive tract from the mouth. Its function is to control the expulsion of feces, the residual semi-solid waste that remains after food digestion, which, ...

fistula A fistula (plural: fistulas or fistulae ; from Latin ''fistula'', "tube, pipe") in anatomy is an abnormal connection between two hollow spaces (technically, two epithelialized surfaces), such as blood vessels, intestines, or other hollow or ...

s in adults with non-active/mildly active luminal

Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, abdominal distension, ...

when

s have shown an inadequate response to at least one conventional or biologic therapy. It contains

mesenchymal stem cell Mesenchymal stem cells (MSCs) also known as mesenchymal stromal cells or medicinal signaling cells are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage ...

s from fat tissue of adult donors. It was approved for use in the European Union in March 2018. The approval was spearheaded by data published in the ADMIRE-CD trial. Darvadstrocel was withdrawn from the EU market in December 2024. It was approved for use in Japan by Japan's

Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...

(MHLW) in September 2021.

Medical use

Darvadstrocel has been approved by the European Union for the treatment of adults with complex Crohn's perianal fistulas after conventional or biological medications have not worked.

Mechanism of action

Darvadstrocel works by reducing

inflammation Inflammation (from la, wikt:en:inflammatio#Latin, inflammatio) is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or Irritation, irritants, and is a protective response involving im ...

and facilitating the growth of tissue in the

tract.

History

ADMIRE-CD

The ADMIRE-CD trial was a phase III trial that assessed the safety and efficacy of darvadstrocel vs. placebo in adults with complex perianal fistulas with Crohn's disease. The study randomized a total of 212 patients. 107 patients were given darvadstrocel and 105 patients were given

placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...

. After one year, the study found darvadstrocel to be effective in closing external fistula openings, compared to

. Patients taking darvadstrocel had a combined remission of 56.3% and clinical remission of 59.2%. The placebo controls had a combined remission of 38.6% and clinical remission of 41.6%.

INSPECT

Published in 2022, the INSPECT study is a retrospective study that evaluated the long-term effectiveness and safety of darvadstrocel in patients with perianal fistulas in

that were treated in the ADMIRE-CD trial. The study data showed that darvadstrocel or the maintenance treatment used can have long term clinical remission in patients.

ADMIRE-CD II

Society and culture

Legal status

Darvadstrocel is approved for medical use in the European Union, Israel, Switzerland, Serbia, the United Kingdom, and Japan. Darvadstrocel was withdrawn from the European Union market in December 2024.

References

External links

* Orphan drugs Stem cells Withdrawn drugs {{antineoplastic-drug-stub