NCT03184935

Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)

Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.

Detailed description

This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including * diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.; * routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.; * stem cell-based medicinal products usage, dosage, time, and course of treatment. Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic umbilical cord mesenchymal stem cells	Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
DRUG	Decitabine	Decitabine，20mg/m\^2/d

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2017-06-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: China