Skip to main content
OpenTrials
Completed

NCT Number: NCT04738981

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graft vs Host Disease Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UC-MSC

Drug

UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.

Other names: Umbilical cord-derived mesenchymal stem cells

Anti-CD25 mAb

Drug

Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.

Other names: Basiliximab

Primary outcomes

  1. Rate of complete remission

    Time frame: 4 weeks after treatment

    Complete remission of aGVHD related symptoms and indicators

Secondary outcomes

  1. Overall survival

    Time frame: At the end of Week 4 / 8 / 12 / 24 / 52.

    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).

  2. Rate of partial remission

    Time frame: 4 weeks after treatment

    improvement of aGVHD staging in one or more organs without progression in other organs

  3. Infusion toxicity

    Time frame: From the beginning of to four hours after every infusion of UC-MSC

    Acute toxicity responses include impaired function of heart, kidney and liver

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Southern Medical University, China
  • Sun Yat-sen University
  • Third Military Medical University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 4, 2021
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.