Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis

Biocells Medical

Status and phase: Suspended; Early Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: Placebo (Normal Saline); Biological: MSC-Derived Exosomes

Study type: Interventional

Funder types: Industry

Identifiers

NCT07146087

Bio120002

Details and patient eligibility

About

The goal of this clinical trial is to learn if intravenous infusion of allogeneic mesenchymal stem cell (MSC)-derived exosomes can slow disability progression and improve neurological function in adults with progressive multiple sclerosis (MS). The trial will also evaluate the safety and tolerability of repeated exosome infusions.

The main questions it aims to answer are:

Does MSC-derived exosome therapy reduce disability progression as measured by the Expanded Disability Status Scale (EDSS)?

Does MSC-derived exosome therapy decrease neuroinflammation and brain lesion burden compared with placebo?

Researchers will compare participants who receive MSC-derived exosome therapy to those who receive placebo (saline infusion) to see if the treatment improves clinical and biological outcomes.

Participants will:

Receive either MSC-derived exosome infusions or placebo infusions every 3 months for 1 year (4 total infusions)

Undergo clinical assessments (neurological exams, EDSS scoring, neurocognitive testing)

Provide blood and cerebrospinal fluid samples for biomarker analysis

Have MRI scans to evaluate lesion load and brain volume

Complete questionnaires on quality of life and daily functioning

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years.
2. Diagnosis of progressive multiple sclerosis (primary or secondary) confirmed
3. EDSS score 3.0-6.5.

Exclusion criteria

1. Relapse or corticosteroid treatment within 3 months before screening.
2. Other significant neurological or autoimmune disorders.
3. Active infection, malignancy, or uncontrolled systemic disease.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

MSC-Derived Exosomes

Experimental group

Description:

Participants receive intravenous infusions of allogeneic mesenchymal stem cell (MSC)-derived exosomes every 12 weeks for 48 weeks (total of 4 infusions) in addition to their stable background MS therapy (if any).

Treatment:

Biological: MSC-Derived Exosomes

Normal Saline

Placebo Comparator group

Description:

Participants receive intravenous infusions of 0.9% sodium chloride (saline) matched in volume, appearance, and schedule to the experimental arm, in addition to their stable background MS therapy (if any).

Treatment:

Biological: Placebo (Normal Saline)