Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745299
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-01-27
Brief Title:
Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel Neuronata-R Inj Treatment in Patients With ALS
Sponsor:
Corestemchemon Inc
Organization:
Corestemchemon Inc
Study Overview
Official Title:
A Double-blind Randomized Multicenter Placebo-Controlled Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of LenzumestrocelNeuronata-R Inj in Patients With Amyotrophic Lateral Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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:
ALSummit
Brief Summary:
ALSUMMIT is a double-blind randomized placebo-controlled multi-center parallel phase III clinical trial to evaluate and confirm the efficacy and long-term safety of repeated Lenzumestrocel Neuronata-R inj treatment
Detailed Description:
Amyotrophic lateral sclerosis ALS is a neurodegenerative disorder characterized by selective and progressive loss of motor neurons Disease progression leads to death within 2-4 years but there exists no definite treatment so far
Based on phase III clinical trialNCT01363401 twice intrathecal autologous bone marrow-derived mesenchymal stem cells Lenzumestrocel injections showed significant therapeutic benefit lasting at least six months with safety in patients with ALS
Additionally the switch from pro- to anti-inflammatory conditions which was indicated from the inverse correlation between TGF-β1 and MCP-1 levels after Lenzumestrocel injections in the good responder has been considered a plausible beneficial action mechanism
This study is designed to investigate the following First to reconfirm and evaluate the long-term efficacy of twice injections single cycle of Lenzumestrocel group 1 will receive a single cycle injection with a 26-day interval
Second to evaluate the long-term safety and efficacy of Lenzumestrocel repeated injections group 2 will receive a single cycle injection a 26-day apart followed by three times injections every three-month interval
Group 3 will receive comparator injections
Based on phase III clinical trialNCT01363401 twice intrathecal autologous bone marrow-derived mesenchymal stem cells Lenzumestrocel injections showed significant therapeutic benefit lasting at least six months with safety in patients with ALS
Additionally the switch from pro- to anti-inflammatory conditions which was indicated from the inverse correlation between TGF-β1 and MCP-1 levels after Lenzumestrocel injections in the good responder has been considered a plausible beneficial action mechanism
This study is designed to investigate the following First to reconfirm and evaluate the long-term efficacy of twice injections single cycle of Lenzumestrocel group 1 will receive a single cycle injection with a 26-day interval
Second to evaluate the long-term safety and efficacy of Lenzumestrocel repeated injections group 2 will receive a single cycle injection a 26-day apart followed by three times injections every three-month interval
Group 3 will receive comparator injections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None