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AstroRx

Phase 1

ALS (Amyotrophic Lateral Sclerosis) | Monoclonal antibody | Neurology |NewcelX Ltd.|Trials Updated: Jan 15, 2021

AstroRx development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

AstroRx clinical trials

AstroRx · 1 trial · 1 indication

Phase 1 1
NCT03482050A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)
COMPLETED16 Analytics
PHASE1COMPLETED
A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)
ALS (Amyotrophic Lateral Sclerosis)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment emergent adverse events as assessed by CTCAE Version 4.03
11 Months

Safety and tolerability assessment will be based on treatment emerged adverse events

Secondary Endpoints

Change in the ALS functional rating scale
11 Months
Change in predicted slow vital capacity (%SVC)
11 Months
Change in muscle strength grading by JAMAR grip strength
11 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AstroRxEXPERIMENTAL -

Interventions

NameTypeDescription
AstroRxBIOLOGICALAstrocytes derived from human embryonic stem cells
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Main Inclusion Criteria: 1. El Escorial criteria for probable or definite ALS 2. Males and and non pregnant females between 18 and 70 years of age 3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or less 4. No history of active psychiatric disorder. Patients rec...

Countries:Israel
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Frequently asked questions about AstroRx

What is AstroRx?

AstroRx is an investigational cell therapy being developed by NewcelX Ltd. for amyotrophic lateral sclerosis (ALS). It consists of astrocytes derived from human embryonic stem cells and is administered by transplantation. AstroRx has been studied in a single Phase 1 clinical trial conducted in Israel.

What is AstroRx used for in ALS?

AstroRx is being developed as a potential treatment for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. The therapy involves transplantation of astrocytes derived from human embryonic stem cells. It is intended to support motor neurons and slow disease progression, though it remains investigational.

Who is developing AstroRx?

AstroRx is being developed by NewcelX Ltd., a biotechnology company. The company's ticker symbol is NCEL. NewcelX is focused on developing cell-based therapies, with AstroRx as its lead candidate for ALS.

What phase is AstroRx in?

AstroRx is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The trial enrolled 16 patients and was conducted in Israel. AstroRx is not approved by the FDA or any other regulatory agency.

What clinical trials is AstroRx in?

AstroRx has been evaluated in a single completed Phase 1 clinical trial, NCT03482050, titled "A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)." The trial enrolled 16 participants in Israel and was an uncontrolled, non-randomized study.