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MSCs for Poor Graft Function After Allo-HSCT

NCT06171906Phase 4

Key facts

Status: Not yet recruiting
Start: Jan 2024
Primary completion: Oct 2025
Countries: 1
Sponsor: ShiCang Yu
Modality: Mesenchymal Stem Cells

Drugs: Provacel
Conditions: poor graft function (PGF)

Overview

Phase 4, open-label, single-arm trial of Provacel in poor graft function (PGF), sponsored by ShiCang Yu. Primary endpoint: Hemogram recovery of patients with poor graft function after treatment. Planned start Jan 2024; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

MSCs treatment group
Mesenchymal stromal cells + Standard of Care

Who it enrols

Adult patients (18-60 years) with poor graft function after allogeneic hematopoietic stem cell transplantation, KPS > 60, and life expectancy > 3 months. Excludes patients with severe organ dysfunction, uncontrolled infection, or other malignant tumors requiring treatment.

Endpoints

Primary

Hemogram recovery of patients with poor graft function after treatment20-40 days post-transplantation

Secondary

Infection rate20-40 days post-transplantation
graft-versus-host disease30-60 days post-transplantation
survival rate1 year post-transplantation

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