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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 : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Biological: Allogeneic umbilical cord mesenchymal stem cells Drug: Decitabine 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

  • 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
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
China, Inner Mongolia
Inner Mongolia International Mongolian Hospital Not yet recruiting
Hohhot, Inner Mongolia, China, 010065
Contact: Wulantuya    864715182155      
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

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03184935     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-03
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:
Myelodysplastic Syndromes
mesenchymal stem cells

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors