Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Registration Number
- NCT03184935
- Lead Sponsor
- Sclnow Biotechnology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 40
- MDS patients with international prostate symptom score is moderate or severe symptoms
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Allogeneic umbilical cord mesenchymal stem cells Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. Experimental group Decitabine Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. Control group Decitabine Basic medication: Decitabine; placebo: saline.
- Primary Outcome Measures
Name Time Method Treatment related-adverse events counting 16 weeks patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
- Secondary Outcome Measures
Name Time Method Improvement in clinical function 16 weeks 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)
Trial Locations
- Locations (1)
Inner Mongolia International Mongolian Hospital
🇨🇳Hohhot, Inner Mongolia, China