Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)

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

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.

Study Overview

• Status: Suspended
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Biological: Allogeneic umbilical cord mesenchymal stem cells; Drug: Decitabine

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
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010065
      • Inner Mongolia International Mongolian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related-adverse events counting	patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	16 weeks

Collaborators and Investigators

• Sponsor: Sclnow Biotechnology Co., Ltd.
• Investigators: Study Director: Shana Chen, Inner Mongolia International Mongolian Hospital; Study Chair: Lei Guo, China-Japan Union Hospital, Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Myelodysplastic Syndromes; mesenchymal stem cells
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: SCLnow-IMIMH-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No