Human Amniotic Epithelial Cells Prevent Acute Graft-versu... | NCT03764228

Studies
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

NCT03764228

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Oct 1, 2020Actual

Enrollment

27Estimated

Phase

Not Applicable

Conditions

Acute-graft-versus-host Disease

Interventions

hAECs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 1, 2021Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Nov 29, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2020

Last Update Posted Date

Oct 1, 2020Actual

Name	Class
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hAECs	Experimental	Infusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10^6, 2×10^6, 5×10^6 cell/kg, successively.	Biological: hAECs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hAECs	Biological	Human amniotic epithelial cells（hAECs）	hAECs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of adverse events	Safety of HSCT combined with hAECs infusion;	1 year

Secondary Outcomes

Measure	Description	Time Frame
GVHD	Occurrence of Graft-versus-host disease after hAECs infusion	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Standard risk GVHD patients with hematological malignancies;
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;

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangyu Zhao	Contact	010-88325949		13520122292@126.com

Overall Officials

Name	Affiliation	Role
Xiaojun Huang	Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Institute of Hematology	Recruiting	Beijing	Beijing Municipality	100044	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38802569	Derived	Yang PJ, Zhao XY, Kou YH, Liu J, Ren XY, Zhang YY, Wang ZD, Ge Z, Yuan WX, Qiu C, Tan B, Liu Q, Shi YN, Jiang YQ, Qiu C, Guo LH, Li JY, Huang XJ, Yu LY. Human amniotic epithelial stem cell is a cell therapy candidate for preventing acute graft-versus-host disease. Acta Pharmacol Sin. 2024 Nov;45(11):2339-2353. doi: 10.1038/s41401-024-01283-y. Epub 2024 May 27.