AI Article Synopsis
- Managing complex perianal fistulizing Crohn's disease is tough, but darvadstrocel, which uses fat-derived stem cells, shows promise in promoting healing and tissue regeneration.
- A literature review identified several studies, including randomized controlled trials, that found darvadstrocel is more effective than a placebo in improving symptoms over time, with similar rates of side effects between the treatment and control groups.
- While darvadstrocel seems to be a safe and effective option for treating complex perianal fistulas, further randomized clinical trials are necessary to confirm its efficacy and safety.
Article Abstract
Background: Managing complex perianal fistulizing Crohn's disease (CD) remains challenging, despite current medical and surgical treatment approaches. Darvadstrocel, a therapy utilizing adipose-derived stem cells, shows promise in promoting tissue regeneration and healing, offering a novel and effective treatment for fistula management.
Method: A systematic literature search was conducted on PubMed and Scopus to identify studies involving patients with complex perianal fistulizing CD treated with darvadstrocel.
Results: In total, 2 randomized controlled trials (RCT), 5 observational studies with retrospective data collection and 2 observational studies with prospective design were included in the final review. Data from the European ADMIRE-CD RCT demonstrated that darvadstrocel is superior to placebo in terms of clinical and imaging improvement over both the short and long term. These findings align with the prospective studies analyzed in this systematic review. The rate of treatment-emergent adverse events in the ADMIRE-CD trial's RCTs was similar in both the darvadstrocel and control groups, with perianal abscess being the most common adverse event up to 52 weeks after drug administration. Retrospective studies indicated no side-effects beyond 52 weeks.
Conclusions: Darvadstrocel appears to be a new, potentially effective and safe treatment option for the management of complex perianal fistulas. However, more randomized clinical trials are needed to evaluate the efficacy and safety profile of the drug.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10785025 | PMC |
| http://dx.doi.org/10.20524/aog.2023.0850 | DOI Listing |
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