Loading clinical trials...

A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

NCT06949267•Ruijin Hospital

View on ClinicalTrials.gov

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 allogeneic hematopoietic stem cell transplantation.

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 experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects.

Eligibility

Age

14 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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;
+1 more criteria

Key Dates

Start Date

June 1, 2025

Primary Completion Date

September 30, 2026

Completion Date

March 31, 2028

Last Updated

April 29, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Graft-versus-Host Disease

Interventions

iMSC

BIOLOGICAL

conventional aGVHD prophylaxis

COMBINATION_PRODUCT

Contacts

Xiaoxia Hu, MD

CONTACT

+86 021-64370045 hu_xiaoxia@126.com

A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

NCT07070674

Acute Graft-versus-Host Disease

View study

RECRUITINGPHASE2

MAGIC Ruxolitinib for aGVHD

NCT06936566

Acute Graft-versus-host DiseaseAllogeneic Bone Marrow Transplantation+1 more

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Inclusion Criteria

Exclusion Criteria

A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

MAGIC Ruxolitinib for aGVHD

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease

Donor Neutrophil Subsets to Predict the Risk of aGVHD

Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease