CDEK
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autologous adipose-derived mesenchymal stem cells

Cell therapyexperimental

Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy. It contains mesenchymal stem cells from fat tissue of adult donors. — Wikipedia

Clinical trial activity

103 trials · 139 clinical orgs · 0 marketing orgs

Phase 1
55
Phase 2
55
Phase 3
13
Phase 4
2

Earliest trial started Jul 31, 2009 (NCT01274975)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Anal fistulas display inflammation and release cytokines. Expanded adipose stem cells have immunomodulatory and anti-inflammatory effects that may promote healing.

  • Unspecified targetTissue restoration

    tissue restoration

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ad-msc transdifferentiated hscs
  • darvadstrocel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07077746Phase 2Jan 31, 2026Hope Biosciences
NCT07230600Phase 1Nov 30, 2025Nanjing University
NCT07205601Phase 2Nov 30, 2025Regeneration Biomedical, Inc.
NCT06956807Phase 1Sep 1, 2025Clinica Universidad de Navarra, Hospital General Universitario Gregorio Marañon, Silesian University of Medicine, Viscofan
NCT06869252Phase 1/Phase 2 (Phase 2)Aug 1, 2025University of Milan
NCT06882811Early Phase 1 (Phase 1)May 22, 2025People's Liberation Army of China
NCT06775964Phase 1/Phase 2 (Phase 2)Feb 28, 2025University of Texas at Houston, Weston Brain Institute
NCT06649864Phase 1Jan 31, 2025Mayo Clinic
NCT06636032Phase 1/Phase 2 (Phase 2)Nov 30, 2024University of Toulouse
NCT06592703Phase 1Oct 31, 2024Etablissement Français du Sang, University of Rennes
NCT06574581Phase 1/Phase 2 (Phase 2)Aug 20, 2024China Medical University
NCT06564740N/AJun 1, 2024Esenyurt State Hospital, Necmi Kadıoğlu Hospital
NCT06391307N/AMay 11, 2024Esenyurt State Hospital, Necmi Kadıoğlu Hospital
NCT06841861Phase 1/Phase 2 (Phase 2)Mar 28, 2024CellARTs Inc., University of California, San Francisco
NCT06156241Phase 1Jan 31, 2024Cord Blood Registry, Inc., University of Texas at Houston
NCT05857371Phase 2Nov 30, 2023Aix-University of Marseille
NCT06726538Phase 1/Phase 2 (Phase 2)Oct 1, 2023Vinmec International Hospital
NCT05669261Phase 1Apr 1, 2023American CryoStem Corporation
NCT05667649Phase 1Jan 31, 2023Regeneration Biomedical, Inc.
NCT05703607Phase 2Jan 25, 2023Pfizer
Showing 20 of 103 trials
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Organizations

Research & Development (139)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mayo ClinicAcademic/Hospital8832017
Hope BiosciencesFor profit5522026
Belarusian State Medical UniversityAcademic/Hospital4012009
Celltex Therapeutics CorporationFor profit4412020
Guangdong Provincial Hospital of Traditional Chinese MedicineAcademic/Hospital4422017
National Academy of Sciences of BelarusAcademic/Hospital4412009
Root Causes MedicineAcademic/Hospital4012020
University of ToulouseAcademic/Hospital4322016
Etablissement Français du SangAcademic/Hospital3032016
Medical University of WarsawAcademic/Hospital3312018
TakedaFor profit3222019
Universidad Autonoma de MadridAcademic/Hospital3122011
University of Texas at HoustonAcademic/Hospital3222021
Aix-University of MarseilleAcademic/Hospital2122012
American CryoStem CorporationFor profit2212021
Anupam HospitalAcademic/Hospital2212016
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2122016
Assiut UniversityAcademic/Hospital2222016
Cha Medical UniversityAcademic/Hospital2222015
Esenyurt State HospitalAcademic/Hospital2012024
139 organizations
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