Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
MSC-Derived Exosomes
+ Placebo (Normal Saline)
Autoimmune Diseases+7
+ Demyelinating Diseases
+ Immune System Diseases
Other Study
Summary
Study start date: July 1, 2020
Actual date on which the first participant was enrolled.This clinical trial aims to determine if a new treatment using special particles called exosomes, derived from mesenchymal stem cells (MSC), can help people with progressive multiple sclerosis (MS). The study focuses on whether these exosomes can slow down the worsening of disabilities and enhance nerve function. It will also assess how safe and tolerable these exosome infusions are for participants. The trial targets adults living with progressive MS, a condition where symptoms gradually get worse, and aims to find ways to improve their quality of life and manage symptoms more effectively. Participants in the study will receive either the exosome treatment or a placebo, which is a harmless saline solution, through an intravenous infusion every three months for one year. The study will involve a series of assessments to track any changes in their condition. These include neurological exams, scoring of disability levels, and cognitive tests. Blood and spinal fluid samples will be collected to look for biological indicators of treatment effect. MRI scans will be used to check for changes in brain lesions and volume. Additionally, participants will fill out questionnaires about their quality of life and daily activities, providing a comprehensive view of how the treatment impacts their lives.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location