Alofisel® (formerly Cx601 / darvadstrocel) 

TiGenix NV discovered Alofisel® (formerly Cx601 / darvadstrocel) and developed this treatment with Takeda. The European Medicines Agency (EMA) approved this treatment for adult patients with Crohn’s disease and complex perianal fistulas.

Alofisel is among the first allogeneic stem cell therapies for a given medical condition. The FDA is currently doing a review of the clinical data to determine approval.  Crohn’s disease is an inflammatory condition of the intestine.

“Alofisel contains allogeneic (donor-derived) expanded adipose-derived stem cells (eASCs), which show immunomodulatory and anti-inflammatory effects at inflammation sites.”

Perianal fistulas is an abnormal complication between the perianal space and the outside skin surface that impacts people with Crohn’s. The inflammation starts in the bowel wall and tends to affect the perianal fistulas. This condition usually happens to patients between 20 and 40.

Alofisel’s Mechanism of Action

Alofisel contains allogeneic adipose-derived stem cells (eASCs). They render immunomodulatory and anti-inflammatory results at inflammation points.

The treatment hinders activated lymphocytes, and at the same time the immunoregulatory traits lower the inflammatory cytokines.

Clinicians administer the treatment by injection.

Clinical Trials on Alofisel

EC’s approved Alofisel after reviewing data from a phase-three clinical trial named ADMIRE-CD.

That study was a randomised, double-blind, parallel-group, placebo-controlled, multi-centre clinical trial. 212 patients participated, receiving a local intralesional injection of either Alofisel 120 million cells or placebo in a 1:1 ratio.

Patients treated with Alofisel reached the primary endpoint of combined remission at week 24.The study identified clinical remission and response at week 24 as secondary endpoints.

Alofisel brought a 44% greater probability of remission compared to placebo.

The study ADMIRE-CD II on Alofisel started in 2017 in an effort to achieve the US Biologic License Application (BLA), which was presented to the FDA.

ADMIRE-CD II is a randomised, double-blind, placebo-controlled study to assess the efficacy and safety of a single injection of Alofisel as a therapy for complex perianal fistulas in Crohn’s disease patients.                                                  


Perianal Disease Using Adipose-derived Stem Cells

An actively recruiting study being done by the University of California that is going to compare the outcomes of using ASC’s versus traditional treatment for patients with perianal fistulas from Crohn’s Disease. The researchers will analyze past medical records of patients who have undergone surgical procedures and compare with follow-up data of treatment with adipose-derived stem cells compared to treatments without the use of stem cells. They will also be taking in patients who have not received past medical treatment to analyze the efficacy compared to patients who have received both previous treatment and ASC’s.

This is an observational study with an estimated enrollment of 25 participants. The procedure involves a fat graft harvest of the participants that will then be loaded into syringes to be injected into the participants.

The primary outcome of this experiment is to review and compare the healing trends, safety, and efficacy of ASC’s compared to primary treatments for patients with perianal disease. This study is actively recruiting patients at this time.


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