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

NCT ID: NCT03184935

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.

Group Type: EXPERIMENTAL

Allogeneic umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Decitabine

Intervention Type: DRUG

Decitabine，20mg/m\^2/d

Control group

Basic medication: Decitabine; placebo: saline.

Group Type: PLACEBO_COMPARATOR

Decitabine

Intervention Type: DRUG

Decitabine，20mg/m\^2/d

Interventions

Allogeneic umbilical cord mesenchymal stem cells

Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Intervention Type: BIOLOGICAL

Decitabine

Decitabine，20mg/m\^2/d

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• MDS patients with international prostate symptom score is moderate or severe symptoms

Exclusion Criteria

• with serious renal function impaired
• with other organ function abnormal: acute hepatitis B, ejection fraction < 40%, serum bilirubin > 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
• bad physical condition (Karmofsky < 60%)
• without signing informed consent form
• under other therapy that possibly influence MSC security or efficacy
• HIV or other serious disease infection
• Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
• Donor/ participants: alcoholism, drug addicted, mental disease

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shana Chen

Role: STUDY_DIRECTOR

Inner Mongolia International Mongolian Hospital

Lei Guo

Role: STUDY_CHAIR

China-Japan Union Hospital, Jilin University

Locations

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Countries

China

Other Identifiers

SCLnow-IMIMH-03

Identifier Type: -

Identifier Source: org_study_id