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- |||| Alofisel (darvadstrocel) / Takeda
Enrollment closed: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (clinicaltrials.gov) - Apr 12, 2022
P3, N=151, Active, not recruiting, Sponsor: Takeda
Recruiting --> Active, not recruiting
- | Alofisel (darvadstrocel) / Takeda
New trial: Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease (clinicaltrials.gov) - Apr 10, 2022
P=N/A, N=14, Completed, Sponsor: Medical University of Vienna
- || Alofisel (darvadstrocel) / Takeda
Review, Journal: Regenerative medicine for digestive fistulae therapy: benefits, challenges and promises of stem/stromal cells and emergent perspectives via their extracellular vesicles. (Pubmed Central) - Mar 17, 2022
The optimal formulation and administration protocol of SC therapy products for gastrointestinal fistula treatment and the challenges for a widespread use of darvadstrocel (Alofisel) in clinical practice will be discussed. Finally, the potential advantages of EV therapy and the obstacles towards their clinical translation will be introduced.
- | Alofisel (darvadstrocel) / Takeda
Journal: Stem Cell Injection for Complex Refractory Perianal Fistulas in Crohn's Disease: A Single Center Initial Experience. (Pubmed Central) - Feb 25, 2022
Although our experience is limited to 3 patients and a short follow-up, our results confirm that darvadstrocel injection is a safe procedure, with a good clinical response in most of the patients, but that it apparently had no effect on the anatomical modification of the fistula tracts. Long-term results, with a rigorous assessment of anatomical lesions, are still needed to support the promising data of the literature.
- |||| Alofisel (darvadstrocel) / Takeda
Clinical: A 9/6 #ADMIRE #Darvadstrocel Long term outcomes (effect and safety) looks promising https://t.co/NGkHVhD44M (Twitter) - Feb 1, 2022
- ||| Alofisel (darvadstrocel) / Takeda
Clinical: A 9/6 #ADMIRE study led by Julian Panes from 🇪🇸 ▶️Cx601 #Darvadstrocel ▶️on ITT analysis 50% vs 36% combined clinical and #MRI remission But 🤔 high placebo rates . ❓#ADMIRE cohort represents practice #MondayNightIBD https://t.co/00hT09toD8 (Twitter) - Feb 1, 2022
- | Alofisel (darvadstrocel) / Takeda
New trial: National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) (clinicaltrials.gov) - Jan 27, 2022
P=N/A, N=150, Recruiting, Sponsor: Universidad de Zaragoza
- Alofisel (darvadstrocel) / Takeda
INSPIRE: 6-month interim analysis from an observational post-marketing registry on the effectiveness and safety of darvadstrocel in patients with Crohn’s disease and complex perianal fistulas (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1321;
These interim analysis data are consistent with the pivotal ADMIRE-CD study in terms of effectiveness and safety. The ongoing status of the registry and small number of evaluable patients mean these data should be interpreted with caution, pending future analyses in larger numbers of patients with longer follow-up times.
- Alofisel (darvadstrocel) / Takeda, Entyvio (vedolizumab) / Takeda
Efficacy and safety of mesenchymal stem cell therapy with darvadstrocel for complex perianal fistulizing Crohn´s disease: multicentric experience in the Basque Country and Navarre (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1111;
Conclusion The initial experience with mesenchymal stem cell therapy show promising results in terms of effectiveness and safety in the short term in complex perianal disease. A longer follow-up period is still needed to confirm these promising data.
- Alofisel (darvadstrocel) / Takeda
Czech experience with treatment of Crohn´s disease perianal fistulas by allogenic mesenchymal stem cell (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1077;
Administration of allogenic, adipose-derived mesenchymal stem cells (darvadstrocel) was studied in a prospective randomised trial (PRS) with a success rate of more than 50%...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 AF, but it can also be used in difficult conditions such as anorectal stenosis or chronic changes in the rectal mucosa.
- Alofisel (darvadstrocel) / Takeda
Allogenic adipose-derived mesenchymal stem cells (darvadstrocel) in Japanese patients with complex perianal fistulas in Crohn’s disease (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1072;
These findings are consistent with the pivotal study ADMIRE-CD, and real-world case-series reported from Europe. Furthermore, no new safety concerns were identified.
- Alofisel (darvadstrocel) / Takeda
Treatment of patients with complex perianal Crohn's disease with darvadstrocel: a single-institution real life experience. (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1019;
Regarding safety, no relevant adverse effects have been observed: 2 patients presented abscesses in the immediate postoperative period (self-drained without subsequent recurrence). Conclusion In real-life clinical practice, treatment with Darvadstrocel can be an effective and safe therapy in patients with CD and complex perianal disease refractory to biological treatment.
- ||| Alofisel (darvadstrocel) / Takeda
Enrollment open: J-INSPIRE: A Survey of Darvadstrocel in People With Crohn's Disease (clinicaltrials.gov) - Dec 5, 2021
P=N/A, N=275, Recruiting, Sponsor: Takeda
Conclusion In real-life clinical practice, treatment with Darvadstrocel can be an effective and safe therapy in patients with CD and complex perianal disease refractory to biological treatment. Not yet recruiting --> Recruiting
- Alofisel (darvadstrocel) / Takeda
S-ECCO IBD Masterclass Lunch Satellite Symposium: Cell-mediated closure in complex Crohn's perianal fistulas: Learning from the real-world evidence! (Virtual Room 4) - Dec 1, 2021 - Abstract #ECCOIBD2022ECCO_IBD_350;
Not yet recruiting --> Recruiting Sponsored by Takeda Programme Invitation Product characteristics: The Summary of Product Characteristics for Alofisel (darvadstrocel) in English is available via: https://www.ema.europa.eu/en/documents/product-information/alofisel-epar-product-information_en.pdf For alternative languages please go to: https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel#product-information-section
- |||||| Alofisel (darvadstrocel) / Takeda
New trial: J-INSPIRE: A Survey of Darvadstrocel in People With Crohn's Disease (clinicaltrials.gov) - Nov 8, 2021
P=N/A, N=275, Not yet recruiting, Sponsor: Takeda
- || mesenchymal stem cells - Cell / Easy, CHU Toulouse, Alofisel (darvadstrocel) / Takeda
Clinical, Review, Journal: Adipose-Derived Stem Cells in the Treatment of Perianal Fistulas in Crohn's Disease: Rationale, Clinical Results and Perspectives. (Pubmed Central) - Oct 22, 2021
A pivotal phase III-controlled trial using allogenic ADSCs (Alofisel) demonstrated that prolonged clinical and radiological remission can be obtained in nearly 60% of cases with a good safety profile. Future studies should be conducted for a better knowledge of the local effect of ADSCs as well as for a standardization in terms of the number of injections and associated procedures.
- || Alofisel (darvadstrocel) / Takeda
Clinical, Journal: Allogeneic expanded adipose-derived mesenchymal stem cell therapy for perianal fistulas in Crohn's disease: A case series. (Pubmed Central) - Sep 5, 2021
This case series demonstrates that the efficacy and safety of Darvadstrocel in the ADMIRE trial can be replicated outside a clinical trial. This new modality in the treatment of perianal complex fistula appears to be a promising therapeutic option for a challenging patient population.
- || NICE, Reimbursement, Review, Journal: Evaluation of Advanced Therapy Medicinal Products by the National Institute for Health and Care Excellence (NICE): An Updated Review. (Pubmed Central) - Aug 21, 2021
There were ten gene therapy products (talimogene laherparepvec [TA410], strimvelis [HST7], tisagenlecleucel [TA554 and TA567], axicabtagene ciloleucel [TA559], voretigene neparvovec [HST11], autologous anti-CD19-transduced CD3+ cells [TA677], betibeglogene autotemcel [ID968], onasemnogene abeparvovec [HST15] and OTL-200 [ID1666]), one tissue engineered product (holoclar [TA467]) and three somatic cell therapy products (darvadstrocel [TA556] and autologous chondrocyte implantation [ACI] [TA477 and TA508])...In conclusion, the challenges raised by the economic appraisal of ATMPs, albeit not unique, may be exacerbated by the uncertainty related to the often scant evidence base. Adaptations of the conventional decision-making process rather than completely new methods may improve appraisals of ATMPs.
- |||||| Alofisel (darvadstrocel) / Takeda
New trial: A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer (clinicaltrials.gov) - Jul 20, 2021
P, N=13080, Not yet recruiting, Sponsor: Takeda
- || Alofisel (darvadstrocel) / Takeda
Clinical, Retrospective data, Journal: Stem cell injection for complex anal fistula in Crohn's disease: A single-center experience. (Pubmed Central) - Jul 17, 2021
Adaptations of the conventional decision-making process rather than completely new methods may improve appraisals of ATMPs. Data of this single-center experience are promising but limited due to the small number of patients and the retrospective analysis.
- || Alofisel (darvadstrocel) / Takeda
Enrollment open: A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease (clinicaltrials.gov) - Jul 16, 2021
P3, N=20, Recruiting, Sponsor: Takeda
Data of this single-center experience are promising but limited due to the small number of patients and the retrospective analysis. Not yet recruiting --> Recruiting
- || Alofisel (darvadstrocel) / Takeda
Retrospective data, Review, Journal: Efficacy of stem cells therapy for Crohn's fistula: a meta-analysis and systematic review. (Pubmed Central) - Jul 7, 2021
Our study has highlighted that stem cells was a promising method in the treatment of Crohn's fistula based on its higher efficacy and lower incidence of adverse events, especially ADSCs and Cx601. While it also needs more clinical and pre-clinical studies to strengthen evidences in the future.
- | Alofisel (darvadstrocel) / Takeda
Journal: Human adipose mesenchymal stem cells modulate myeloid cells toward an anti-inflammatory and reparative phenotype: role of IL-6 and PGE2. (Pubmed Central) - Jun 22, 2021
The results demonstrate that ASCs are able to modulate the in vitro differentiation of myeloid cells toward an anti-inflammatory and reparative profile. This modulatory effect was mediated mainly by PGE2 and, to a lesser extent, IL-6.
- | Alofisel (darvadstrocel) / Takeda
Alofisel. Funciona ? (Twitter) - Jun 4, 2021
- Alofisel (darvadstrocel) / Takeda
[VIRTUAL] Predictive modelling to examine long term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn’s Disease (Virtual Room 1) - Jun 3, 2021 - Abstract #ECCOIBD2021ECCO_IBD_1339;
Conclusion In this pooled analysis, we used predictive modelling to examine the effectiveness of DVS vs. SoC over a longer time. Inclusion of RWE to the model indicates possible maintenance of the disease-modifying effect of DVS over a longer time period.
- |||| Alofisel (darvadstrocel) / Takeda
Trial completion date, Trial primary completion date: ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (clinicaltrials.gov) - May 12, 2021
P3, N=554, Recruiting, Sponsor: Tigenix S.A.U.
Inclusion of RWE to the model indicates possible maintenance of the disease-modifying effect of DVS over a longer time period. Trial completion date: Sep 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Aug 2022
- ||| Alofisel (darvadstrocel) / Takeda
Trial completion date, Trial primary completion date: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (clinicaltrials.gov) - May 12, 2021
P3, N=150, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial completion date: Sep 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Aug 2022 Trial completion date: Dec 2024 --> Feb 2024 | Trial primary completion date: Dec 2024 --> Feb 2024
- | Alofisel (darvadstrocel) / Takeda
Journal: Darvadstrocel for the treatment of perianal fistulas in Crohn's disease. (Pubmed Central) - Apr 27, 2021
This drug profile educates the reader with this novel treatment approach.Areas covered: A literature search was performed on PubMed with focus on perianal fistulizing Crohn's disease and mesenchymal stem (stromal) cells. This review summarizes evidence of the current standard of care and discusses the mechanism of action, manufacturing, and application and safety of darvadstrocel.Expert Opinion: Darvadstrocel is a safe and effective therapy for complex perianal fistulizing Crohn's disease.
- [VIRTUAL] Advanced Therapy Medicinal Products Treatments- Key Drivers from Initial Health Technology Assessment Decisions in Germany, France and the UK () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_788;
CONCLUSIONS Reimbursement is depending on the effect size of benefit and durability of response and could be limited to some subpopulations and not the fully approved indication. Agreements are also in place for economic affordability.
- Alofisel (darvadstrocel) / Takeda
[VIRTUAL] LOCAL MESENCHYMAL STEM/STROMAL CELL THERAPY IS MORE COST-EFFECTIVE THAN FECAL DIVERSION FOR THE TREATMENT OF PERIANAL CROHN’S DISEASE FISTULAS (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_3266;
Autologous MSC therapy is also more effective and less costly than FD, with an expected total cost of $7,455, which is $10,188 less than FD. Costs for expected complications are $584 less for MSC than FD.
- |||| Alofisel (darvadstrocel) / Takeda
New P3 trial: A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease (clinicaltrials.gov) - Jan 7, 2021
P3, N=20, Not yet recruiting, Sponsor: Takeda
- || Alofisel (darvadstrocel) / Takeda
Clinical, Journal, IO Biomarker: Dissecting Allo-Sensitization After Local Administration of Human Allogeneic Adipose Mesenchymal Stem Cells in Perianal Fistulas of Crohn's Disease Patients. (Pubmed Central) - Nov 12, 2020
The present study aims to assess allo-immune responses in a cohort of Crohn's disease patients administered with allogeneic ASC (darvadstrocel formerly Cx601) for the treatment of complex perianal fistulas...It is still unknown whether DSA generation could potentially be the consequence of donor-to-patient interaction and, therefore, subsequently link to efficacy or biological activity. Lastly, we propose that CDC modulators such as CD46 could be used to ultimately link CDC specificity with allogeneic cell therapy efficacy.
- | Alofisel (darvadstrocel) / Takeda
Trial primary completion date: Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease (clinicaltrials.gov) - Oct 4, 2020
P3, N=22, Active, not recruiting, Sponsor: Takeda
Lastly, we propose that CDC modulators such as CD46 could be used to ultimately link CDC specificity with allogeneic cell therapy efficacy. Trial primary completion date: Feb 2021 --> Jul 2020
- Alofisel (darvadstrocel) / Takeda
Enrollment open: ASPIRE: A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (clinicaltrials.gov) - Oct 4, 2020
P4, N=50, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial primary completion date: Feb 2021 --> Jul 2020 Not yet recruiting --> Recruiting
- [VIRTUAL] Market Access Landscape for Advanced Therapy Medicinal Products in the EU-5 () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1648;
Two ATMPs, Zynteglo and Zolgensma are currently being evaluated by NICE. CONCLUSIONS Most ATMPs are granted patient access in EU5 even though HTA bodies have imposed monitoring requirements to ensure the value reflects the price.
- Strimvelis (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) / Orchard Therap, Alofisel (darvadstrocel) / Takeda, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
[VIRTUAL] Advanced Therapies- New Challenge for the Italian Pricing and Reimbursement System. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_525;
Rate of approvals and variability in time to reimbursement underline the complexity, both from a clinical and economic point of view, of assessing those therapies by AIFA; the uncertainty on efficacy in the long term is mainly managed through performance based agreements but is not impacting the overall value recognition once reimbursement is granted (60% innovative status). Treatment costs needs to be put in the context of rare disease and small eligible patient populations.
- | Alofisel (darvadstrocel) / Takeda
Journal: Alofisel® gegen Perianalfisteln bei M. Crohn : Chronisch entzündliche Darmerkrankungen. (Pubmed Central) - Jul 15, 2020
Treatment costs needs to be put in the context of rare disease and small eligible patient populations. No abstract available
- |||||| Alofisel (darvadstrocel) / Takeda
Enrollment open: ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (clinicaltrials.gov) - Jun 9, 2020
P3, N=554, Recruiting, Sponsor: Tigenix S.A.U.
No abstract available Active, not recruiting --> Recruiting
- Alofisel (darvadstrocel) / Takeda
Trial initiation date: ASPIRE: A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (clinicaltrials.gov) - May 10, 2020
P4, N=50, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Initiation date: May 2020 --> Aug 2020
- ||||| Alofisel (darvadstrocel) / Takeda
Enrollment closed: ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (clinicaltrials.gov) - Apr 21, 2020
P3, N=554, Active, not recruiting, Sponsor: Tigenix S.A.U.
Initiation date: May 2020 --> Aug 2020 Recruiting --> Active, not recruiting
- | Alofisel (darvadstrocel) / Takeda
Journal: Cx601 (darvadstrocel) for the treatment of perianal fistulizing Crohn's disease. (Pubmed Central) - Apr 14, 2020
Whether MSCs have benefit in non-complex fistula in biological naïve patients, in complex fistula with many tracts and/or in rectovaginal fistulas, are unexplored fields that need further investigation. A central registry of pCD patients undergoing treatment with MSC should be created in order to elucidate the efficacy, safety and costs of stem cells treatment on long term follow up.
- [VIRTUAL] MANAGED ENTRY AGREEMENTS FOR ATMPS DESPITE ACCESS ALREADY GRANTED? THE CASE OF GERMANY () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_78;
Some of them are intended to support product adoption, others as part of the official pricing. This indicates that MEA more applications beyond the abovementioned definition.
- || Alofisel (darvadstrocel) / Takeda
Enrollment closed, Trial completion date, Trial primary completion date: Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease (clinicaltrials.gov) - Mar 3, 2020
P3, N=22, Active, not recruiting, Sponsor: Takeda
This indicates that MEA more applications beyond the abovementioned definition. Recruiting --> Active, not recruiting | Trial completion date: Nov 2020 --> Jan 2023 | Trial primary completion date: May 2020 --> Feb 2021
- Alofisel (darvadstrocel) / Takeda
Trial initiation date: ASPIRE: A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (clinicaltrials.gov) - Jan 21, 2020
P4, N=50, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Nov 2020 --> Jan 2023 | Trial primary completion date: May 2020 --> Feb 2021 Initiation date: Jan 2020 --> May 2020
- |||| Alofisel (darvadstrocel) / Takeda
Trial completion date, Trial primary completion date: ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (clinicaltrials.gov) - Jan 18, 2020
P3, N=554, Recruiting, Sponsor: Tigenix S.A.U.
Initiation date: Jan 2020 --> May 2020 Trial completion date: Oct 2021 --> Sep 2022 | Trial primary completion date: Oct 2021 --> Mar 2022
- ||| Alofisel (darvadstrocel) / Takeda
#CelulasMadre #Darvadstrocel #Alofisel #EnfermedadDeCrohn #Patentes @TakedaPharma @UAM_Madrid @ipbln_csic (Twitter) - Dec 3, 2019
- ||||||| Alofisel (darvadstrocel) / Takeda
Trial completion: ADMIRE-CD: Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease (clinicaltrials.gov) - Nov 29, 2019
P3, N=278, Completed, Sponsor: Tigenix S.A.U.
Trial completion date: Oct 2021 --> Sep 2022 | Trial primary completion date: Oct 2021 --> Mar 2022 Active, not recruiting --> Completed
- |||| Alofisel (darvadstrocel) / Takeda
Enrollment open: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula (clinicaltrials.gov) - Nov 28, 2019
P3, N=150, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | Alofisel (darvadstrocel) / Takeda
New P4 trial: ASPIRE: A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula (clinicaltrials.gov) - Oct 7, 2019
P4, N=50, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- | Alofisel (darvadstrocel) / Takeda
Enrollment change: ADMIRE-CD-II: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (clinicaltrials.gov) - Sep 26, 2019
P3, N=600, Recruiting, Sponsor: Tigenix S.A.U.
Not yet recruiting --> Recruiting N=326 --> 600