RecruitingPhase 1NCT06671236

Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases

An Open, Single-Arm, Multi-Center Clinical Study to Evaluate the Safety and Tolerability of Regulatory T Cells (Tregs) In the Treatment of Neurodegenerative Diseases


Sponsor

Novabio Therapeutics

Enrollment

12 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cell therapy using special immune cells called regulatory T cells (Tregs) to treat neurodegenerative diseases like ALS (Lou Gehrig's disease). These cells may help calm the harmful inflammation that damages the nervous system. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of ALS (amyotrophic lateral sclerosis) or another neurodegenerative disease covered by the study - Any current ALS medications (like riluzole or edaravone) have been at a stable dose for at least one month - It has been at least two weeks since any major surgery **You may NOT be eligible if...** - You have a serious infection or uncontrolled medical condition - You have recently received certain other experimental treatments - You do not meet the specific diagnosis criteria confirmed by international standards Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection)

Regulatory T cell therapy, intrathecal injection


Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06671236


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