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

Study 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.

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

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Biological: Allogeneic umbilical cord mesenchymal stem cells
* Drug: Decitabine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. | Biological: Allogeneic umbilical cord mesenchymal stem cells<br>* Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)<br>Drug: Decitabine<br>* Decitabine，20mg/m^2/d<br>|
| Placebo Comparator: Control group<br>Basic medication: Decitabine; placebo: saline. | Drug: Decitabine<br>* Decitabine，20mg/m^2/d<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelodysplastic Syndromes, mesenchymal stem cells