Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

NCT ID: NCT04454840

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2019-05-01

Brief Summary

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

Detailed 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).

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biological+Riluzole

Plasma from healthy young people treatment + Riluzole

Group Type: EXPERIMENTAL

Plasma from healthy young people treatment + Riluzole

Intervention Type: BIOLOGICAL

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.

Riluzole

Riluzole

Group Type: ACTIVE_COMPARATOR

Riluzole

Intervention Type: DRUG

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

Interventions

Plasma from healthy young people treatment + Riluzole

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.

Intervention Type: BIOLOGICAL

Riluzole

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

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongsheng Fan, MD.PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

PUTH2017118

Identifier Type: -

Identifier Source: org_study_id