Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454840
• Other study ID #: PUTH2017118
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Biological:
• 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.

Drug:
• Riluzole
The basic treatment is Riluzole 25~50mg twice daily

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyotrophic lateral sclerosis Functional Rating Scale scores	Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes	22 months after intervention
Secondary	Survival time	The time of the end event (death, tracheotomy, continuous ventilator dependence);	22 months after intervention
Secondary	Forced vital capacity (FVC)	The change from baseline to the end of follow-up;	22 months after intervention
Secondary	Cognitive function evaluation (ECAS score)	The change from baseline to the end of follow-up;	22 months after intervention