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

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Acute Graft Versus Host Disease

Treatments: Biological: placebo (cell preservation solution); Biological: Human amniotic epithelial stem cells（hAESCs）

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06444022

NFEC-2019-128

Details and patient eligibility

About

This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

hAESCs

Experimental group

Description:

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.

Treatment:

Biological: Human amniotic epithelial stem cells（hAESCs）

placebo (cell preservation solution)

Placebo Comparator group

Description:

Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT.

Treatment:

Biological: placebo (cell preservation solution)