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. 2023 Oct 5;14:1241068. doi: 10.3389/fimmu.2023.1241068

Table 1.

Overview of current clinical studies using MSCs for the treatment of GVHD.

Sponsor, Country Product Phase
Status
Planned Participants Study Title (ClinicalTrials.gov Clinical Trial Number)
EudraCT Number (if available)
Medac GmbH, Germany MC0518 Phase 3 Recruiting 210 A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial) (NCT04629833) EudraCT Number: 2019-001462-15
University of Liege, Belgium MSCs Phase 2 Recruiting 100 Infusion of Mesenchymal Stem Cells as Treatment for Steroid-Resistant Grade II to IV Acute GVHD or Poor Graft Function: a Multicenter Phase II Study (NCT00603330) EudraCT Number: 2007-004310-14
Andalusian Initiative for Advanced Therapies, Spain Adult Allogeneic MSCs from adipose tissue Phase 1/2
Active, not recruiting
16 Clinical Trial Phase I/II Graft Versus Host Disease Treatment Refractory to First-line Therapy with Sequential Infusion of Mesenchymal Cells Allogeneic Expanded Adipose Tissue in Vitro (NCT02687646) EudraCT Number: 2014-005533-32
MD Anderson Cancer Center, USA Cord blood tissue-derived MSCs Pilot study Recruiting 24 A Randomized Controlled Pilot Study of Two Doses of Cord Blood Tissue-Derived Mesenchymal Stromal Cells Combined with Ruxolitinib Versus Ruxolitinib Alone for Therapy of Steroid-Refractory Acute Graft Versus Host Disease (NCT04744116)
Edwin Horwitz, Emory University, USA IFNγ-primed human BM-derived MSCs Phase 1
Recruiting
45 Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease After Allogeneic Hematopoietic Cell Transplantation for Patients with Hematologic Malignancies and Myelodysplasia (NCT04328714)
University of Kansas Medical Center, USA MSCTC-0010 UC Wharton’s jelly MSCs Phase 1
Recruiting
10 A Phase I Study to Evaluate the Safety of Umbilical Cord - Derived, Ex-Vivo Cultured and Expanded Wharton’s Jelly Mesenchymal Stem Cells for the Treatment of De Novo High Risk Acute or Steroid Refractory Acute Graft Versus Host Disease (NCT03158896)
Peking University People’s Hospital, China Umbilical cord MSCs and anti-CD25 mAb Phase 3
Not yet recruiting
130 Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial (NCT04738981)
Nanfang Hospital of Southern Medical University, China MSCs Phase 2 Recruiting 152 Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation (NCT04692376)
Shenzhen University General Hospital, China UC MSCs Phase 1/2 Recruiting 10 Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate/Severe Chronic Graft-versus-host Disease (NCT05152160)
Cytopeutics Sdn. Bhd., Malaysia Cytopeutics® UC-derived MSCs Phase 1/2 Recruiting 40 Cytopeutics® Umbilical Cord Mesenchymal Stem Cells (Cyto-MSC) for Patients with Grade II-IV Acute Graft-Versus-Host Disease: A Phase I/II Clinical Study (NCT03847844)
SCM Lifescience Co., LTD., Korea SCM-CGH (BM MSCs) Phase 2 Recruiting 77 A Multicenter, Randomized, Parallel Group, Double-blind, Phase 2 Trial to Evaluate Efficacy and Safety of SCM-CGH in Patients with Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease (NCT04189432)

Source: www.clinicaltrials.gov (date accessed: 14 February 2022).