MSC for Severe aGVHD

F

Fujian Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Steroid-resistant Severe aGVHD

Treatments

Biological: MSCs

Study type

Interventional

Funder types

Other

Identifiers

NCT03631589
MSC-SCT-01

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

Under 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

MSCs treated
Experimental group
Treatment:
Biological: MSCs

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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