Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.

Detailed Description
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This is a single-center, open-label clinical study to evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis. The main outcome indicators are the record of adverse reactions and the rate of change of amyotrophic lateral sclerosisFunctional Rating Scale score. The secondary outcome indicators include survival time-time to the end event (death, tracheotomy, continuous ventilator dependence), forced vital capacity (FVC), recognition Knowledge function evaluation (ECAS score).

Official Title
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A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Biological: Plasma from healthy young people treatment + Riluzole
* Drug: Riluzole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis; Age 50-70 years old ; 3-18 months course of disease; Forced vital capacity (FVC) ≥70% predicted value; Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, scores of respiratory related items ≥10; Take Riluzole regularly before participate in this trial (25 50mg twice a day for at least 30 days continuously) without obvious side effects and can continue to take for 22 months; Participants of childbearing age take reasonable and effective contraceptive measures from the time of enrollment to the end of follow-up; Signed informed consent. Exclusion Criteria: Familial amyotrophic lateral sclerosis; Female during pregnancy and lactation; Positive hepatitis B, hepatitis C or HIV in screening History of cytomegalovirus and malaria infection; After tracheotomy and ventilator-dependent state (daily use of non-invasive ventilator ≥ 22 hours for 7 consecutive days); After percutaneous gastrostomy (PEG) operation; Has had allergic reactions and other adverse reactions during blood transfusion; Have diseases of the blood system (including Immunoglobulin A deficiency); alanine transaminase, Aspartate transaminase≥ 3 times the upper limit of normal; Abnormal renal function (Cr, BUN); History of malignant tumors; Combining severe cardiopulmonary diseases, autoimmune diseases, mental diseases, substance abuse history, etc; Currently participating in other clinical studies or using other drugs in researching.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological+Riluzole<br>Plasma from healthy young people treatment + Riluzole | Biological: Plasma from healthy young people treatment + Riluzole<br>* Intravenous injection: the subjects received 400ml of intravenous plasma infusion every 2 weeks, with a continuous course of 2 treatments and a course of treatment every 3 months. The course of treatment lasted 10 months, with a total of 3200ml of plasma infusion.<br>|
| Active Comparator: Riluzole<br>Riluzole | Drug: Riluzole<br>* The basic treatment is Riluzole 25 50mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyotrophic lateral sclerosis Functional Rating Scale scores | Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes | 22 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time | The time of the end event (death, tracheotomy, continuous ventilator dependence); | 22 months after intervention | 
| Forced vital capacity (FVC) | The change from baseline to the end of follow-up; | 22 months after intervention | 
| Cognitive function evaluation (ECAS score) | The change from baseline to the end of follow-up; | 22 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic lateral sclerosis; Plasma infusion