Co-transplantation of MSC in the Setting of Allo-HSCT

Fujian Medical University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Biological: Cotransplant with MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT04247945

MSC-SCT-03

Details and patient eligibility

About

Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• Aged <65 years
• Willing to transplant
• 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: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

HSC

No Intervention group

MSC+HSC

Experimental group

Treatment:

Biological: Cotransplant with MSCs