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

Acute Graft Versus Host Disease Clinical Trial

Official title:

Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444022
• Other study ID #: NFEC-2019-128
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Xiaojun Huang, MD
• Phone: 13701389625
• Email: huangxiaojun[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Biological:
• Human amniotic epithelial stem cells(hAESCs)
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)
• placebo (cell preservation solution)
Same dose placebo (cell preservation solution) injections as control group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of acute graft-versus-host disease in patients	Occurrence and severity (grade) of Graft-versus-host disease after hAECs infusion	1 year
Secondary	Immune reconstitution 6 months before and after hematopoietic stem cell transplantation	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	6 months
Secondary	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	The amount of cytokines in plasma was measured: TGF-b	1 month
Secondary	Incidence of CMV and EBV infection	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;	1 year