Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03180450
Status:
SUSPENDED
Last Update Posted:
2025-05-14
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
Sponsor:
Sclnow Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Status:
SUSPENDED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Others
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: