MSC for Severe aGVHD

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)

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50 participants in 1 patient group

MSCs treated

Experimental group

Treatment:

Biological: MSCs