Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke "ACTIsSIMA"

Active, not recruiting

Phase 2 Results N/A

Trial Description

Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke

Detailed Description

This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke. The study will be conducted at approximately 65 sites in the United States.
Two cohorts, Group 1 (2.5 and 5 million SB623 cells combined) and Group 2 (sham placebo), will be included in this study. Subjects who are randomized into this study will receive either 2.5 million SB623 cells, 5 million SB623 cells or sham surgery at a 1:1:1 randomization ratio. Randomization will be performed via an interactive web/voice response system (IXRS), stratified by Screening mRS score (recorded in the IXRS at the clinical site).

Conditions

Interventions

  • SB623 Implant (2.5M) Biological
    Intervention Desc: 2.5 million SB623 cells
    ARM 1: Kind: Experimental
    Label: SB623 Implant (2.5M)
    Description: 2.5 million SB623 cells
  • SB623 Implant (5.0M) Biological
    Intervention Desc: 5 million SB623 cells
    ARM 1: Kind: Experimental
    Label: SB623 Implant (5.0M)
    Description: 5 million SB623 cells
  • Sham surgery Procedure
    ARM 1: Kind: Experimental
    Label: Sham Control
    Description: Sham surgery

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of subjects whose Fugl-Meyer Motor scale (FMMS) improve by ≥10 points at Month 6 from Baseline Month 6 No
Secondary Proportion of subjects whose Modified Rankin Scale (mRS) improve by ≥1 point at Month 6 from Baseline Month 6 No
Secondary Proportion of subjects whose Action Research Arm Test (ARAT) improve by ≥6 points Month 6 No
Secondary Proportion of subjects whose Gait Velocity on standard 10 m walk improve at least one functional level [eg, from < 0.4 m/s to 0.4-0.8 m/s or from 0.4 0.8 m/s to >0.8 m/s]) at Month 6 from Baseline Month 6 No
Secondary Mean change in T scores at Month 6 of NeuroQOL sub-domains Upper Extremity Function (Fine motor ADL) Lower Extremity Function (Mobility) Month 6 No
Secondary Proportion of subjects scoring 7 (much better) or 6 (a little improved) in the Global Rating of Perceived Change scores at Month 6 assessed by subject (may be completed by caregiver) and by clinician Month 6 No
Secondary All adverse events whether or not related to SB623 or surgical procedure using WHO toxicity criteria Month 12 No
Secondary Adverse changes imaged by head MRI Month 12 No
Secondary Serious adverse events (SAEs) using WHO toxicity criteria Month 12 No
Secondary Serum chemistry hematology, vital signs, physical examinations Month 12 No
Secondary Changes in serum antibodies to SB623 over time Month 12 No
Secondary Proportion of subjects whose Gait Velocity on standard 10 m walk improve at least one functional level [eg, from < 0.4 m/s to 0.4-0.8 m/s or from 0.4 0.8 m/s to >0.8 m/s]) at Month 6 from Baseline Month 6 No

Sponsors