Back to resultsResearch for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
Primary Purpose
Myelodysplastic Syndromes
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic umbilical cord mesenchymal stem cells
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplastic Syndromes, mesenchymal stem cells
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
Sites / Locations
- Inner Mongolia International Mongolian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
Basic medication: Decitabine; placebo: saline.
Outcomes
Primary Outcome Measures
Treatment related-adverse events counting
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
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)
Full Information
NCT ID
NCT03184935
First Posted
June 6, 2017
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03184935
Brief Title
Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
Official Title
Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Others
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Myelodysplastic Syndromes, mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Basic medication: Decitabine; placebo: saline.
Intervention Type
Biological
Intervention Name(s)
Allogeneic umbilical cord mesenchymal stem cells
Intervention Description
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
Decitabine，20mg/m^2/d
Primary Outcome Measure Information:
Title
Treatment related-adverse events counting
Description
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Improvement in clinical function
Description
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)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shana Chen
Organizational Affiliation
Inner Mongolia International Mongolian Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Guo
Organizational Affiliation
China-Japan Union Hospital, Jilin University
Official's Role
Study Chair
Facility Information:
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010065
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
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