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

NCT ID: NCT06444022

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Graft Versus Host Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human amniotic epithelial stem cells（hAESCs）

Intervention Type: BIOLOGICAL

Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)

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.

Group Type: PLACEBO_COMPARATOR

placebo (cell preservation solution)

Intervention Type: BIOLOGICAL

Same dose placebo (cell preservation solution) injections as control group

Interventions

Human amniotic epithelial stem cells（hAESCs）

Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)

Intervention Type: BIOLOGICAL

placebo (cell preservation solution)

Same dose placebo (cell preservation solution) injections as control group

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojun Huang

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Central Contacts

Xiaojun Huang, MD

Role: CONTACT

huangxiaojun@bjmu.edu.cn

13701389625

Other Identifiers

NFEC-2019-128

Identifier Type: -

Identifier Source: org_study_id