Status:
COMPLETED
Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Peking University Third Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
Phase:
EARLY_PHASE1
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 scleros...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04454840
Start Date
May 1 2016
End Date
May 1 2019
Last Update
July 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, China