Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Early Phase 1CompletedNCT04454840

Peking University Third Hospital20 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Plasma from healthy young people treatment + RiluzoleBIOLOGICAL

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.

RiluzoleDRUG

The basic treatment is Riluzole 25\~50mg twice daily

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Peking University Third Hospital

Beijing, China

Outcomes

Primary Outcomes

Amyotrophic lateral sclerosis Functional Rating Scale scores

Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes

Time frame: 22 months after intervention

Secondary Outcomes

Survival time

The time of the end event (death, tracheotomy, continuous ventilator dependence);

Time frame: 22 months after intervention

Forced vital capacity (FVC)

The change from baseline to the end of follow-up;

Time frame: 22 months after intervention

Cognitive function evaluation (ECAS score)

The change from baseline to the end of follow-up;

Time frame: 22 months after intervention

Data from ClinicalTrials.gov

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