Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
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diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
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routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells. |
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
|
| Placebo Comparator: Control group Basic medication: Decitabine; placebo: saline. |
Drug: Decitabine
Decitabine，20mg/m^2/d
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- MDS patients with international prostate symptom score is moderate or severe symptoms
Exclusion Criteria:
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with serious renal function impaired
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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
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bad physical condition (Karmofsky < 60%)
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without signing informed consent form
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under other therapy that possibly influence MSC security or efficacy
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HIV or other serious disease infection
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Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
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Donor/ participants: alcoholism, drug addicted, mental disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inner Mongolia International Mongolian Hospital | Hohhot | Inner Mongolia | China | 010065 |
Sponsors and Collaborators
- Sclnow Biotechnology Co., Ltd.
Investigators
- Study Director: Shana Chen, Inner Mongolia International Mongolian Hospital
- Study Chair: Lei Guo, China-Japan Union Hospital, Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCLnow-IMIMH-03