Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: Riluzole

Criteria

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.