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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03184935
• Other study ID #: SCLnow-IMIMH-03
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: December 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Inner Mongolia International Mongolian Hospital	Hohhot	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in clinical function	According to 'Diagnostic and Curative Criteria of Hematological Diseases' 3rd edition edited by Zhang Zhinan and Shen Di, evaluate the hUC-MSCs efficacy. The result as follow: complete remission (CR); partial remission (PR); stable disease (SD); progressive disease (PD)	16 weeks