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

NCT06444022 | Withdrawn Phase 1 DMC

• 1 other identifier: NFEC-2019-128
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Graft Versus Host Disease

Keywords

hAESCs

Outcome Measures

Primary Outcomes (1)

• Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)

  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.

  1 year

Secondary Outcomes (4)

• Rate of acute graft-versus-host disease in patients

  1 year

• Immune reconstitution 6 months before and after hematopoietic stem cell transplantation

  6 months

• 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

• Incidence of CMV and EBV infection

  1 year

Study Arms (2)

hAESCs

EXPERIMENTAL

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.

Biological: Human amniotic epithelial stem cells（hAESCs）

placebo (cell preservation solution)

PLACEBO COMPARATOR

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

Biological: placebo (cell preservation solution)

Interventions

Human amniotic epithelial stem cells（hAESCs） BIOLOGICAL

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

hAESCs

placebo (cell preservation solution) BIOLOGICAL

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

placebo (cell preservation solution)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: collaborator

Study Officials

• Xiaojun Huang

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study plans to recruit 18 participants who meet the criteria and is divided into two groups with 9 subjects individually. Infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: June 5, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04