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

Sclnow Biotechnology

Status and phase

Suspended

Phase 2

Phase 1

Conditions

Myelodysplastic Syndromes

Treatments

Biological: Allogeneic umbilical cord mesenchymal stem cells

Drug: Decitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03184935

SCLnow-IMIMH-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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