Status:
NOT_YET_RECRUITING
A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Ruijin Hospital
Conditions:
Acute Graft-versus-Host Disease
Eligibility:
All Genders
14-70 years
Phase:
EARLY_PHASE1
Brief Summary
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allo...
Detailed Description
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to e...
Eligibility Criteria
Inclusion
- Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
- No gender restrictions and age between 14-70 years old；
- Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
- Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP\< 0.14 at +7d, another test was performed at +14d)；
- Estimated survival≥ 24 weeks；
- Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；
- Subjects were be treated within 5 days after enrollment；
- Informed consent and willingness to participate in the study.
Exclusion
- Serious organ dysfunction such as organ failure after allogeneic HSCT;
- Received more than once HSCT (including autologous transplants);
- Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
- Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
- Primary malignant hematologic disease was not remission;
- Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;
- Those who are suffering mental or neurological illnesses, unable to express will correctly;
- Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;
- Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;
- Have participated or are participating in another clinical trial within one month prior to enrollment;
- Those who are judged by the investigator to be unsuitable for participation in this clinical trial.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06949267
Start Date
June 1 2025
End Date
March 31 2028
Last Update
April 29 2025
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