Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695521
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-01-03
Brief Title:
Regulatory T Cells for Amyotrophic Lateral Sclerosis
Sponsor:
Cellenkos Inc
Organization:
Cellenkos Inc
Study Overview
Official Title:
Phase 1 Safety Run-in Study and Phase 1b Randomized Double Blinded Placebo Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
REGALS
Brief Summary:
Phase 1 Safety Run-in Study of 6 patients followed by Phase 1b Randomized Double Blind Placebo Control Trial of CK0803 neurotropic allogeneic umbilical cord blood derived T regulatory Treg cells in additional 60 patients with Amyotrophic Lateral Sclerosis
Detailed Description:
CK0803 neurotrophic allogenic T regulatory Cells Treg utilizes Cellenkos proprietary CRANE technology to generate disease specific products The primary objective of the upcoming phase 1 study is to establish safety and tolerability of multiple doses of CK0803 in ALS patients The goal of the phase 1b study is to extend safety and establish efficacy of CK0803 in ALS using the combined assessment of function and survival CAFS that ranks patients clinical outcomes based on survival time and change in the ALS Functional Rating Scale-Revised ALSFRS-R score
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