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Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04454840
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Plasma from healthy young people treatment + Riluzole
  • Drug: Riluzole
 Early Phase 1

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Open Lable
Primary Purpose:
Treatment
Official Title:
A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biological+Riluzole

Plasma from healthy young people treatment + Riluzole

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.
Active Comparator: Riluzole

Riluzole

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

Outcome Measures

Primary Outcome Measures

  1. Amyotrophic lateral sclerosis Functional Rating Scale scores [22 months after intervention]

    Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes

Secondary Outcome Measures

  1. Survival time [22 months after intervention]

    The time of the end event (death, tracheotomy, continuous ventilator dependence);

  2. Forced vital capacity (FVC) [22 months after intervention]

    The change from baseline to the end of follow-up;

  3. Cognitive function evaluation (ECAS score) [22 months after intervention]

    The change from baseline to the end of follow-up;

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Dongsheng Fan, MD.PHD, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04454840
Other Study ID Numbers:
  • PUTH2017118
First Posted:
Jul 2, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Amyotrophic lateral sclerosis; Plasma infusion
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Riluzole

Study Results

No Results Posted as of Jul 7, 2020