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

NCT03184935 | Suspended Phase 1

• 1 other identifier: SCLnow-IMIMH-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Treatment related-adverse events counting

  patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells

  16 weeks

Secondary Outcomes (1)

• Improvement in clinical function

  16 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Biological: Allogeneic umbilical cord mesenchymal stem cells; Drug: Decitabine

Control group

PLACEBO COMPARATOR

Basic medication: Decitabine; placebo: saline.

Drug: Decitabine

Interventions

Allogeneic umbilical cord mesenchymal stem cells BIOLOGICAL

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

Experimental group

Decitabine DRUG

Decitabine，20mg/m\^2/d

Control group; Experimental group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, 010065, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Shana Chen

  Inner Mongolia International Mongolian Hospital

  STUDY DIRECTOR

• Lei Guo

  China-Japan Union Hospital, Jilin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 14, 2017
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)