NCT03180450

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients

Detailed description

This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)	Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.
DRUG	conventional treatment	The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc.

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2017-06-08
• Last updated: 2025-05-14

Locations

1 site across 1 country: China