Products
Darvadstrocel was approved in the EU and many countries in 2018 in the form of an injection suspension (Alofisel). The suspension contains 5 million live cells per milliliter.
Structure and properties
These are expanded, human, allogeneic (from another individual), mesenchymal, adult stem cells derived from adipose tissue. In English, they are referred to as (eASC). The cells are derived from the subdermal adipose tissue of humans and are obtained with the help of liposuction and subsequent processing.
Effects
Darvadstrocel has immunomodulatory and anti-inflammatory properties. Adipose tissue stem cells are activated by cytokines, which are released locally by activated lymphocytes. They then inhibit lymphocyte proliferation and reduce the release of inflammatory mediators.
Indications
For the treatment of complex perianal fistulas in Crohn’s disease, as a second-line agent.
Dosage
According to the SmPC. The drug is injected intralesionally in a surgical setting under anesthesia.
Contraindications
- Hypersensitivity
For complete precautions, see the drug label.
Adverse effects
The most common possible adverse effects include anal abscess, proctalgia, and anal fistulas.
