hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Stopped: The research content involving the use of hAESCs for the prevention of aGVHD after HSCT has completed the IND application for treating the said condition. Therefore, an application is submitted to terminate this research project.
0Started 2026-06-01
Plain-language summary
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Standard risk GVHD patients with hematological malignancies older than 18 years;
* High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
* Well informed about this study and signed a consent form before the trial;
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
* No evidence of lung infection by X-rays examination;
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
* Normal liver and kidney function: Serum bilirubin≤35µmol/L, AST/ALT was less than 2 times the upper limit of normal value, and serum creatinine ≤130µmol/L
Exclusion Criteria:
* Reduce pretreatment dose or secondary transplantation;
* Participate other clinical trials within 2 months before this study;
* Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
* History of severe allergic disease or is allergic to one or more drugs;
* Patients who are considered unsuitable for the study by the investigator.
What they're measuring
1
Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
Timeframe: 1 year
Trial details
NCT IDNCT06444022
SponsorNanfang Hospital, Southern Medical University