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).