Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT03184935|
Recruitment Status : Suspended (Others)
First Posted : June 14, 2017
Last Update Posted : September 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Biological: Allogeneic umbilical cord mesenchymal stem cells Drug: Decitabine||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
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#)
Placebo Comparator: Control group
Basic medication: Decitabine; placebo: saline.
- 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
- Improvement in clinical function [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184935
|China, Inner Mongolia|
|Inner Mongolia International Mongolian Hospital|
|Hohhot, Inner Mongolia, China, 010065|
|Study Director:||Shana Chen||Inner Mongolia International Mongolian Hospital|
|Study Chair:||Lei Guo||China-Japan Union Hospital, Jilin University|