NCT05116540

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

A Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each eligible study subject will receive a total of 6 intravenous infusions of HB-adMSCs or placebo. Study infusions will be administered with the following regimen, Week 0, 4, 8, 16, 24, and 32. There will be one follow-up visit and end of study at week 52.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	HB-adMSCs	Autologous product
DRUG	Placebo	Normal Saline

Timeline

• Start date: 2021-11-24
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2021-11-11
• Last updated: 2025-09-26
• Results posted: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study