Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518902
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating Acute Ischemic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Arm Open Label Exploratory Clinical Study on the Safety Tolerability and Preliminary Efficacy of Mesenchymal Stem Cells Umbilical Cord Injection in the Treatment of Acute Ischemic Stroke AIS Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UMERIS
Brief Summary:
The goal of this clinical trial is to learn if drug mesenchymal stem cells umbilical cord injection works to treat acute ischemic stroke in adults It will also learn about the safety and efficacy of drug mesenchymal stem cells umbilical cord injection The main questions it aims to answer are
Identify the dose-limiting toxicity DLT of drug mesenchymal stem cells umbilical cord injection in acute ischemic stroke patients
Dose the drug mesenchymal stem cells umbilical cord injection improves the mRS score NIHSS score Fugl-Meyer score and and Barthel index of acute ischemic stroke patients What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells umbilical cord injection in the treatment of acute ischemic stroke patients
What is the the possible molecular mechanisms of mesenchymal stem cells umbilical cord injection in the treatment of acute ischemic stroke patients
Participants will
Take drug drug mesenchymal stem cells umbilical cord injection once or once a week for three consecutive weeks
After receiving the corresponding dose of mesenchymal stem cells umbilical cord injection the subjects entered a 6-month safety efficacy observation and further safety evaluation period Long term efficacy and survival follow-up up to 2 years
Identify the dose-limiting toxicity DLT of drug mesenchymal stem cells umbilical cord injection in acute ischemic stroke patients
Dose the drug mesenchymal stem cells umbilical cord injection improves the mRS score NIHSS score Fugl-Meyer score and and Barthel index of acute ischemic stroke patients What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells umbilical cord injection in the treatment of acute ischemic stroke patients
What is the the possible molecular mechanisms of mesenchymal stem cells umbilical cord injection in the treatment of acute ischemic stroke patients
Participants will
Take drug drug mesenchymal stem cells umbilical cord injection once or once a week for three consecutive weeks
After receiving the corresponding dose of mesenchymal stem cells umbilical cord injection the subjects entered a 6-month safety efficacy observation and further safety evaluation period Long term efficacy and survival follow-up up to 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None