MSC for Severe aGVHD

Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03631589

Enrollment

Registered

2018-08-15

Start date

2017-12-01

Completion date

2021-12-01

Last updated

2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid-resistant Severe aGVHD

Brief summary

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.

Interventions

BIOLOGICALMSCs

mesenchymal stem cells therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
complete and partial response rate	1 year

Secondary

Measure	Time frame
Adverse events that are related to treatment	1 year

Countries

China

Contacts

Primary ContactJianda Hu, Prof.M.D.Ph.D

drjiandahu@163.com86-13959169016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026