Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04590118
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2020-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)
Sponsor:
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Organization:
Study Overview
Official Title:
A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Multicenter, Blind, Randomized, Placebo Controlled Single Injection of It-hMSC in Patients With Ischemic Stroke
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of single injection of it-hMSC in patients with ischemic stroke in a multicenter, blind, randomized, placebo controlled trial
Detailed Description:
Stroke is a leading cause of disability. According to the comprehensive standardized prevalence estimation in 2016, 12.42 million people older than 40 years in China are currently suffering from stroke or have ever suffered from stroke. The overall prevalence rate of stroke in China was 1,596 per 100,000 people in 2016, 4.6 times higher than the rate of 345.1 per 100,000 people in 2013 and 70% of the survivors have disabilities in varying degrees. In addition to rehabilitation therapy, there is no therapeutic drugs of remarkable curative effect for the treatment of ischemic stroke patients. The latest data show that the annual recurrence rate of ischemic stroke in China is as high as 17.7%.
Allogeneic mesenchymal stem cells have been used in many clinical studies for different diseases. In addition to differentiating into multiple cell types and promoting the recovery and repair of the brain by replacing damaged cells, mesenchymal stem cells also secrete cytokines and neurotrophic factors to support and stimulate the growth of other endogenous cells. Meanwhile, mesenchymal stem cells also have anti-inflammatory and immunomodulatory functions. These characteristics of mesenchymal stem cells provide a new therapy for the treatment of stroke.
Allogeneic mesenchymal stem cells have been used in many clinical studies for different diseases. In addition to differentiating into multiple cell types and promoting the recovery and repair of the brain by replacing damaged cells, mesenchymal stem cells also secrete cytokines and neurotrophic factors to support and stimulate the growth of other endogenous cells. Meanwhile, mesenchymal stem cells also have anti-inflammatory and immunomodulatory functions. These characteristics of mesenchymal stem cells provide a new therapy for the treatment of stroke.
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?: