hAECs Are Preliminarily Applied in Allogeneic Hematopoiet... | NCT03759899

Studies
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

NCT03759899

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Oct 1, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

Not provided

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 2021Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Nov 19, 2018

First Submission Date that Met QC Criteria

Nov 29, 2018

First Posted Date

Nov 30, 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

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojun Huang,MD, Director of the Hematology Department, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Detailed Description

Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cell counts of T cells, NK cells, B cells and monocytes	proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients	Day 7

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

leukemia patients with allogeneic HSCT
KFS score >90
after transplantation, the patient was implanted (peripheral blood neutrophil absolute value >500/ul for 3 consecutive days)
no uncontrolled infection after transplantation
activity II above aGVHD
patients agreed to participate in the study

Exclusion Criteria:

patients refused to participate in the study
patients have poor compliance
has received hormone therapy
patients had serious heart, lung, liver, kidney and other vital organs damage
researchers believe that patients who are not suitable for observation study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

leukemia patients with allogeneic HSCT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiangyu Zhao	Contact	010-88325949		zhao_xy@bjmu.edu.cn

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided