Status:
COMPLETED
Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Southern Medical University, China
Third Military Medical University
Conditions:
Graft Vs Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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-hos...
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 antibodie...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04738981
Start Date
February 1 2021
End Date
May 2 2023
Last Update
June 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010