MSC for Severe aGVHD

NCT ID: NCT03631589

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-12-01

Brief Summary

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Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.

Detailed Description

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Conditions

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Steroid-resistant Severe aGVHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MSCs treated

Group Type EXPERIMENTAL

MSCs

Intervention Type BIOLOGICAL

mesenchymal stem cells therapy

Interventions

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MSCs

mesenchymal stem cells therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Aged \<65 years
* Patients with steroid-resistant severe aGVHD
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianda Hu

Director of the department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianda Hu, Prof.M.D.Ph.D

Role: CONTACT

86-13959169016

Facility Contacts

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Jianda Hu, Prof.

Role: primary

86-13959169016

Ting Yang, Prof.

Role: backup

86-13950210357

Other Identifiers

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MSC-SCT-01

Identifier Type: -

Identifier Source: org_study_id

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