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New treatment option for Amyotrophic Lateral Sclerosis (ALS)
Official title Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases
ClinicalTrials.gov ID: NCT06671236
What this study is testing
What is Autologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection)?
Autologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for amyotrophic lateral sclerosis (als).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- \- Patients must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female patients aged 18 to 70 years;
- According to current international diagnostic criteria: ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of...
- If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole...
- Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials;
You likely can't join if
- \- people with any of the following cannot be enrolled in this study:
- uncontrolled infection;
- \< 3 drugs do not adequately control hypertension;
- Documented history of pulmonary embolism within 6 months of enrollment;
- Clinically significant cardiology, defined as: myocardial infarction, NYHA-graded class III or IV heart failure, uncontrolled angina, severe...
- Patients with a history of coronary artery bypass grafting or angioplasty will be evaluated by cardiology and considered on a case-by-case basis;
See the full eligibility criteria
- \- Patients must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female patients aged 18 to 70 years;
- According to current international diagnostic criteria: ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed as...
- If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole (Rilutek®) and/or edaravone (Radicava®);
- Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials;
- Patients must have recovered from clinical toxicity (CTCAE [5th Edition] toxicity values have resolved to \< 2);
- Serum creatinine less than or equal to 2.0 mg/dL;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal;
- Bilirubin \< 1.5 (except Gilbert's disease);
- Lung slow vital capacity (SVC) \> 70% of predicted normal;
- No history of abnormal bleeding tendency;
- Informed consent must be obtained prior to performing any study-related procedures that are not part of standard medical care, with the understanding that the participant may withdraw from the study without influence...
- \- people with any of the following cannot be enrolled in this study:
- uncontrolled infection;
- \< 3 drugs do not adequately control hypertension;
- Documented history of pulmonary embolism within 6 months of enrollment;
- Clinically significant cardiology, defined as: myocardial infarction, NYHA-graded class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or ECG evidence of acute ischemia or...
- Patients with a history of coronary artery bypass grafting or angioplasty will be evaluated by cardiology and considered on a case-by-case basis;
- Seropositive for HIV, hepatitis B or hepatitis C;
- Pregnant or lactating patients;
- Patients of childbearing potential or males with partners of childbearing potential who are unwilling to use contraception;
- Participation in any other treatment study;
- Treatment with another investigational drug, biologic, or device within 30 days or 5 half-lives (whichever is longer) of the screening period. Patient participation in observational/non-treatment clinical studies will...
- Prior treatment with ALS gene or cell therapy;
- History of clinically significant tumor, liver or kidney disease, or other uncontrolled disease;
- presence of a feeding tube;
- Current use of antipsychotics, antiepileptic drugs (except benzodiazepines, gabapentin, pre-Bahrain) or class 1 (e.g., flecainide) or class 3 (e.g., amiodarone) antiarrhythmic drugs;
- people who, in the opinion of the investigator, are at significant risk of suicide;
- Other conditions that the investigator considers unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.