Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184935
Recruitment Status : Unknown
Verified May 2017 by Sclnow Biotechnology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 6, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Estimated Study Start Date  ICMJE July 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2017)
Security evaluation [ Time Frame: 16 weeks ]
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Change History Complete list of historical versions of study NCT03184935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2017)
Efficacy evaluation [ 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
Official Title  ICMJE Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndromes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Experimental group
    Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.
    Interventions:
    • Biological: Allogeneic umbilical cord mesenchymal stem cells
    • Drug: Decitabine
  • Placebo Comparator: Control group
    Basic medication: Decitabine; placebo: saline.
    Intervention: Drug: Decitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184935
Other Study ID Numbers  ICMJE SCLnow-IMIMH-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sclnow Biotechnology Co., Ltd.
Study Sponsor  ICMJE Sclnow Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shana Chen Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo China-Japan Union Hospital, Jilin University
PRS Account Sclnow Biotechnology Co., Ltd.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP