Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn’s Disease

Scott, Lesley J.

doi:10.1007/s40259-018-0311-4

Cited by 42 publications

(24 citation statements)

References 25 publications

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“…This is described in the label of the commercially approved product available in Europe (Alofisel TM , Darvadstrocel, Takeda Pharma A/S, Taastrup, Denmark). According to the label, the product is indicated for treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal CD, when fistulas have shown an inadequate response to at least one conventional or biologic therapy [62,63]. Alofisel TM is composed of human allogeneic mesenchymal adult stem cells from adipose tissue (expanded adipose stem cells—eASCs).…”

Section: Application and Results Of Mscs In Perianal Fistulizing Cmentioning

confidence: 99%

“…Alofisel TM is composed of human allogeneic mesenchymal adult stem cells from adipose tissue (expanded adipose stem cells—eASCs). Cells are extracted from subdermal adipose tissue by liposuction, from healthy adult donors, and are subsequently expanded in laboratory facilities [62]. The adipose tissue obtained is then digested with type 1 collagenase to extract the MSCs, which are then separated by centrifuge.…”

Section: Application and Results Of Mscs In Perianal Fistulizing Cmentioning

confidence: 99%

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Mesenchymal Stem Cells for Perianal Crohn’s Disease

Carvello

Lightner

Yamamoto

et al. 2019

Cells

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Perianal fistulizing Crohn’s disease (PFCD) is associated with significant morbidity and might negatively impact the quality of life of CD patients. In the last two decades, the management of PFCD has evolved in terms of the multidisciplinary approach involving gastroenterologists and colorectal surgeons. However, the highest fistula healing rates, even combining surgical and anti-TNF agents, reaches 50% of treated patients. More recently, the administration of mesenchymal stem cells (MSCs) have shown notable promising results in the treatment of PFCD. The aim of this review is to describe the rationale and the possible mechanism of action of MSC application for PFCD and the most recent results of randomized clinical trials. Furthermore, the unmet needs of the current administration process and the expected next steps to improve the outcomes will be addressed.

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Section: Application and Results Of Mscs In Perianal Fistulizing Cmentioning

confidence: 99%

Section: Application and Results Of Mscs In Perianal Fistulizing Cmentioning

confidence: 99%

Mesenchymal Stem Cells for Perianal Crohn’s Disease

Carvello

Lightner

Yamamoto

et al. 2019

Cells

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“…Alofisel®, an allogeneic MSC therapy for complex perianal fistula in Crohn's disease, is the only MSC product approved by the EMA. Its mechanism of action seems to involve MSCs' ability to inhibit the proliferation of activated lymphocytes and thereby reduce pro‐inflammatory cytokine production 49 . A similar product, Cupistem®, is an autologous adipose‐derived MSC product that received approval from the KFDA in 2012 to treat patients with Crohn's fistula.…”

Section: Clinically Approved Productsmentioning

confidence: 99%

Cell therapies in the clinic

Wang

Janes

Kumbhojkar

et al. 2021

Bioengineering & Transla Med

105

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Cell therapies have emerged as a promising therapeutic modality with the potential to treat and even cure a diverse array of diseases. Cell therapies offer unique clinical and therapeutic advantages over conventional small molecules and the growing number of biologics. Particularly, living cells can simultaneously and dynamically perform complex biological functions in ways that conventional drugs cannot; cell therapies have expanded the spectrum of available therapeutic options to include key cellular functions and processes. As such, cell therapies are currently one of the most investigated therapeutic modalities in both preclinical and clinical settings, with many products having been approved and many more under active clinical investigation. Here, we highlight the diversity and key advantages of cell therapies and discuss their current clinical advances. In particular, we review 28 globally approved cell therapy products and their clinical use. We also analyze >1700 current active clinical trials of cell therapies, with an emphasis on discussing their therapeutic applications. Finally, we critically discuss the major biological, manufacturing, and regulatory challenges associated with the clinical translation of cell therapies.

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“…Darvadstrocel (named Cx601 during drug development, and now commercially known as Alofisel) is the tenth ATMP approved in the EU under this definition (Table 1) and the first cell therapy based on allogeneic cells [10,11]. This product is based on adipose tissue derived mesenchymal stromal cells (MSCs) and its labeled therapeutic indication is for the treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy [12].…”

Section: Tercel and A Case Of Successful Public-private Collaborationmentioning

confidence: 99%

Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research

et al. 2020

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In the current article we summarize the 15-year experience of the Spanish Cell Therapy Network (TerCel), a successful collaborative public initiative funded by the Spanish government for the support of nationwide translational research in this important area. Thirty-two research groups organized in three programs devoted to cardiovascular, neurodegenerative and immune-inflammatory diseases, respectively, currently form the network. Each program has three working packages focused on basic science, pre-clinical studies and clinical application. TerCel has contributed during this period to boost the translational research in cell therapy in Spain, setting up a network of Good Manufacturing PracticeÀcertified cell manufacturing facili-tiesÀ and increasing the number of translational research projects, publications, patents and clinical trials of the participating groups, especially those in collaboration. TerCel pays particular attention to the public-private collaboration, which, for instance, has led to the development of the first allogeneic cell therapy product approved by the European Medicines Agency, Darvadstrocel. The current collaborative work is focused on the development of multicenter phase 2 and 3 trials that could translate these therapies to clinical practice for the benefit of patients.

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Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn’s Disease

Cited by 42 publications

References 25 publications

Mesenchymal Stem Cells for Perianal Crohn’s Disease

Mesenchymal Stem Cells for Perianal Crohn’s Disease

Cell therapies in the clinic

Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research

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