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

Graft Vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738981
• Other study ID #: GVHD-PKU2021
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) = 0.5 x 10^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.

Exclusion Criteria:

• 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.

6. Patients who are deemed unsuitable for the study by the investigator.

Related Conditions & MeSH terms

• Graft Vs Host Disease

Intervention

Drug:
• UC-MSC
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.
• Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg,twice in first week and once a week thereafter, for 4 weeks.

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University People's Hospital	Southern Medical University, China, Sun Yat-sen University, Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete remission	Complete remission of aGVHD related symptoms and indicators	4 weeks after treatment
Secondary	Overall survival	The time from randomization to death for any reason ( the last follow-up time for missing patients; end date of follow-up for patients who are live at the end of the study).	At the end of Week 4 / 8 / 12 / 24 / 52.
Secondary	Rate of partial remission	improvement of aGVHD staging in one or more organs without progression in other organs	4 weeks after treatment
Secondary	Infusion toxicity	Acute toxicity responses include impaired function of heart, kidney and liver	From the beginning of to four hours after every infusion of UC-MSC