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Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis

NCT05116540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-26

Study results available
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Summary

Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.

Conditions

Interventions

BIOLOGICAL

HB-adMSCs

Autologous product

DRUG

Placebo

Normal Saline

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    lead INDUSTRY

Principal Investigators

  • Djamchid Lotfi, MD · Hope Biosciences Stem Cell Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2024-06-04
Completion
2024-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116540 on ClinicalTrials.gov