Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
Overview
- Phase
- Phase 1
- Intervention
- Decitabine
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Sclnow Biotechnology Co., Ltd.
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Treatment related-adverse events counting
- Status
- Suspended
- Last Updated
- 9 days ago
Overview
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.
Investigators
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
Arms & Interventions
Experimental group
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
Intervention: Decitabine
Experimental group
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
Intervention: Allogeneic umbilical cord mesenchymal stem cells
Control group
Basic medication: Decitabine; placebo: saline.
Intervention: Decitabine
Outcomes
Primary Outcomes
Treatment related-adverse events counting
Time Frame: 16 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Secondary Outcomes
- Improvement in clinical function(16 weeks)