hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment to help prevent a serious condition called acute graft-versus-host disease (aGVHD) that can occur after a hematopoietic stem cell transplant (HSCT). In simple terms, aGVHD happens when the donor's immune cells attack the recipient's body. The trial will test a special type of cells, called hAECs, to see if they can safely help reduce the risk of this condition.

If you or someone you know is between 18 and 74 years old and has certain types of blood cancers, you might be eligible to participate. To qualify, you should have a standard or high risk of developing aGVHD, be in good overall health, and not be pregnant or nursing. Participants in this trial will receive close medical care and monitoring to ensure their safety throughout the study. It's important to note that this trial is not yet recruiting participants, so interested individuals will need to wait until it starts.

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Eligibility criteria

• 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.