NCT03696485

Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS

A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stem Cell Medicine Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS.

Detailed description

Twelve (12) SPMS subjects will be enrolled in this study in two dose cohorts. Each subject will receive SCM- 010 by intrathecal (IT) administration at baseline and will be followed up for 24 weeks for efficacy and 48 weeks for safety.

Conditions

• Secondary Progressive Multiple Sclerosis (SPMS)

Interventions

Type	Name	Description
BIOLOGICAL	SCM-010	SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2018-10-04
• Last updated: 2024-04-18

Locations

1 site across 1 country: Israel