Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Peking University

Status and phase

Completed

Early Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Riluzole

Biological: Plasma from healthy young people treatment + Riluzole

Study type

Interventional

Funder types

Other

Identifiers

NCT04454840

PUTH2017118

Details and patient eligibility

About

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

Full description

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).

Enrollment

20 patients

Sex

All

Volunteers

No Healthy Volunteers

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.