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

• ClinicalTrials.gov Identifier: NCT03184935
• Recruitment Status: Unknown
• First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Sponsor: Sclnow Biotechnology Co., Ltd.
• Information provided by (Responsible Party): Sclnow Biotechnology Co., Ltd.

Tracking Information

• First Submitted Date: June 6, 2017
• First Posted Date: June 14, 2017
• Last Update Posted Date: June 14, 2017
• Estimated Study Start Date: July 2017
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Myelodysplastic Syndromes

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 11, 2017): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2018
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03184935
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Sclnow Biotechnology Co., Ltd.
• Study Sponsor: Sclnow Biotechnology Co., Ltd.
• Collaborators: Not Provided

Investigators

• 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