- |||||||||| Alofisel (darvadstrocel) / Takeda
Retrospective data, Review, Journal: Darvadstrocel for complex perianal fistulas in Crohn's disease: A systematic review and meta-analysis. (Pubmed Central) - Oct 3, 2024 Evidence from observational studies supports the efficacy and safety of darvadstrocel for complex perianal fistulas in CD. Studies have reported high fistula healing rates that can be sustained long-term in most patients, with negligible between-study heterogeneity, as well as a favorable safety profile.
- |||||||||| Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim, Alofisel (darvadstrocel) / Takeda, Tremfya (guselkumab) / J&J
4435: Immunology, Microbiology & Inflammatory Bowel Diseases (IMIBD) Section Distinguished Abstract Plenary (Ballroom B - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_6013; Description: This session highlights the best of the best in basic and clinical science research submitted to DDW 2024. Learning Objectives: Describe the efficacy and safety of guselkumab, darvadstrocel, and risankizumab for the treatment of IBD
- |||||||||| Alofisel (darvadstrocel) / Takeda
Journal, Real-world evidence, Real-world: Mesenchymal stem cell therapy for Crohn's perianal fistula-a real-world experience. (Pubmed Central) - Jan 29, 2024 Learning Objectives: Describe the efficacy and safety of guselkumab, darvadstrocel, and risankizumab for the treatment of IBD In this real-world experience, treatment of Crohn's disease complex perianal fistulas with darvadstrocel had a 61% success rate for maintained clinical remission.
- |||||||||| Clinical guideline: Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology. (Pubmed Central) - Mar 28, 2023
This document presents recommendations regarding six clinical settings, from the induction to the maintenance of clinical remission, and from optimization and de-escalation of treatments to dealing with perianal CD and post-operative recurrence. The 19 evidence-based statements are supported by information on the quality of the evidence, agreement rate among panel members, and panel comments mainly based on evidence from real world studies.
- |||||||||| Alofisel (darvadstrocel) / Takeda
Trial completion: Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease (clinicaltrials.gov) - Mar 10, 2023 P3, N=22, Completed, The 19 evidence-based statements are supported by information on the quality of the evidence, agreement rate among panel members, and panel comments mainly based on evidence from real world studies. Active, not recruiting --> Completed
- |||||||||| Alofisel (darvadstrocel) / Takeda
Review, Journal: Use of Mesenchymal Stem Cells in Crohn's Disease and Perianal Fistulas: A Narrative Review. (Pubmed Central) - Mar 9, 2023 Finally, darvadstrocel, a cell-based medication to treat complex anal fistulas in adults, as the only European Medicines Agency (EMA)-approved product for the treatment of anal fistulas in CD is addressed...One of the most widely used cell sources administrated in cell therapy is mesenchymal stem cell (MSC). This review article will discuss preclinical and clinical studies about MSCs as a potent and promising therapeutic option in the treatment of CD and anal fistula.
- |||||||||| Alofisel (darvadstrocel) / Takeda
Enrollment change, Trial completion date, Trial primary completion date: A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer (clinicaltrials.gov) - Mar 8, 2023 P=N/A, N=5850, Not yet recruiting, This review article will discuss preclinical and clinical studies about MSCs as a potent and promising therapeutic option in the treatment of CD and anal fistula. N=13080 --> 5850 | Trial completion date: Oct 2027 --> Nov 2026 | Trial primary completion date: Dec 2025 --> Nov 2026
- |||||||||| Alofisel (darvadstrocel) / Takeda
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) (clinicaltrials.gov) - Jan 18, 2023 P=N/A, N=63, Completed, It also shows a positive impact on the quality of life of patients, particularly those for whom a combined clinical-radiological response was achieved. Recruiting --> Completed | N=150 --> 63 | Trial completion date: Dec 2022 --> Apr 2022 | Trial primary completion date: Dec 2022 --> Apr 2022
- |||||||||| Alofisel (darvadstrocel) / Takeda
Review, Journal: Searching for the Optimal Donor for Allogenic Adipose-Derived Stem Cells: A Comprehensive Review. (Pubmed Central) - Nov 15, 2022 After being approved in the European Union, UK, Switzerland, Israel, and Japan, allogeneic adipose-derived stem cells (darvadstrocel) have been recently granted a regenerative medicine advanced therapy (RMAT) designation by US FDA for complex perianal fistulas in adults with Crohn's disease...The current knowledge on adipose stem cell harvest describes quantitative and qualitative differences that could be influenced by different donor conditions and donor sites. In this comprehensive review, we summarize the current knowledge on the topic and propose donor profiles that could provide the optimal initial quality of this living drug, as a starting point for further applications and studies in different pathological conditions.
- |||||||||| Alofisel (darvadstrocel) / Takeda
Journal, Video: Injection of mesenchymal stem cells (darvadstrocel) into Crohn's perianal fistula - a video vignette. (Pubmed Central) - Oct 5, 2022 Real-world follow-up of patients from the ADMIRE-CD trial indicates that clinical remission of complex perianal fistulas can be sustained in the long term irrespective of whether it is achieved through darvadstrocel administration or maintenance treatment regimens and confirms a favorable long-term safety profile of darvadstrocel. No abstract available
- |||||||||| Alofisel (darvadstrocel) / Takeda
P3 data, Journal: Darvadstrocel for complex perianal fistulas in Japanese adults with Crohn's disease: a phase 3 study. (Pubmed Central) - Sep 24, 2022 Stem cell therapy (SCT) shows promise in inducing remission in refractory Crohn's colitis, and perianal fistula, but further research is required before SCT could be applied to clinical practice guidelines. The efficacy and tolerability of darvadstrocel in Japanese adult patients with treatment-refractory complex perianal fistulas in Crohn's disease were similar to those observed in the previous European study.
- |||||||||| Alofisel (darvadstrocel) / Takeda
CZECH EXPERIENCE WITH TREATMENT OF CROHN S DISEASE PERIANAL FISTULAS BY ALLOGENIC MESENCHYMAL STEM CELLS (Science Lounge) - Jul 20, 2022 - Abstract #UEGW2022UEGW_1972; Another reason for better outcome could be proper selection of patients with long term stable conservative treatment, which demonstrates stable CD. In our conditions, this treatment is similarly effective as eradication of the fistula using Advancement Flap, but it can also be used in difficult conditions such as anorectal stenosis or chronic inflammatory changes of rectal mucosa.
- |||||||||| Alofisel (darvadstrocel) / Takeda
Journal, HEOR: Mesenchymal Stem/Stromal Cell Therapy Is More Cost-Effective Than Fecal Diversion for Treatment of Perianal Crohn's Disease Fistulas. (Pubmed Central) - Jul 6, 2022 MSCs locally injected into pCD can lead to healing, and a phase III clinical trial (ADMIRE-CD) showed 66% clinical response, leading to approval of MSCs (Alofisel, Takeda) in the European Union...We therefore developed a decision tree model to determine the cost-effectiveness of MSCs compared to FD for pCD. Our study showed that both autologous and allogeneic MSCs are more cost-effective than FD in an academic medical center and even in a worst-case scenario with 100% chance of all complications for MSCs treatment and 0% chance of complications for FD, both allogeneic and autologous MSCs are still cost saving compared to FD.
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