NCT04738981

Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT

Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.

Detailed description

A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	UC-MSC	UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.
DRUG	Anti-CD25 mAb	Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-05-30
• Completion: 2023-05-02
• First posted: 2021-02-04
• Last updated: 2023-06-01

Locations

1 site across 1 country: China