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NCT06949267

EARLY_PHASE1

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-01

Completion Date

2028-03-31

Last Updated

2025-04-29

Healthy Volunteers

Conditions

Acute Graft-versus-Host Disease

Interventions

BIOLOGICAL

iMSC

1× 10\^6/kg each time, twice a week

COMBINATION_PRODUCT

conventional aGVHD prophylaxis

Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin（ATG）

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; * Those who are judged by the investigator to be unsuitable for participation in this clinical trial.