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Regulatory T Cells for Amyotrophic Lateral Sclerosis — REGALS  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05695521
Study type Interventional
Source Cellenkos, Inc.
Contact Clinical Research Manager
Phone 212-305-6788
Email alsresearch@columbia.edu
Status Recruiting
Phase Phase 1
Start date April 3, 2023
Completion date December 2027
View Details
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