hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
- Conditions
- Acute Graft Versus Host Disease
- Interventions
- Biological: Human amniotic epithelial stem cells（hAESCs）Biological: placebo (cell preservation solution)
- Registration Number
- NCT06444022
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
- Detailed Description
This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10\^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hAESCs Human amniotic epithelial stem cells（hAESCs） Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10\^6 cell/kg. placebo (cell preservation solution) placebo (cell preservation solution) Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT.
- Primary Outcome Measures
Name Time Method Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE) 1 year AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study.
hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE.
- Secondary Outcome Measures
Name Time Method Immune reconstitution 6 months before and after hematopoietic stem cell transplantation 6 months 10 days(d) before hematopoietic stem cell transplantation and 1d, 7d±2, 14d±2, 21d±2, 28d±2, 3 month(m) ± 2 days , 6 m ± 2 days, testing expression of immune cells
Incidence of CMV and EBV infection 1 year Hematopoietic stem cell transplantation after 7 days ±2, 14 days ±2, 21 days±2, 28d±2, 2M±2 days, 3M±2 days, 6M±2 days, 12M±2 days;
Rate of acute graft-versus-host disease in patients 1 year Occurrence and severity (grade) of Graft-versus-host disease after hAECs infusion
Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured 1 month The amount of cytokines in plasma was measured: TGF-b