The Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Chronic Spinal Cord Injury (SCI) Receiving Rehabilitation

NCT02354625 Phase 1 COMPLETED

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) transplantation in participants with chronic SCI. This trial design is phase I, open label, unblinded, non-randomized, and non-placebo controlled multiple injury cohorts.

Details

Lead sponsor	W. Dalton Dietrich
Phase	Phase 1
Status	COMPLETED
Enrolment	8
Start date	2015-01
Completion	2019-08-12

Conditions

• Spinal Cord Injury
• Paraplegia
• Quadriplegia
• Tetraplegia

Interventions

• Autologous human Schwann cells

Primary outcomes

• International Standards of Neurological Classification of Spinal Cord Injury — Change from Baseline at 6 months
• Magnetic Resonance Imaging of spinal cord — Change from Baseline at 6 months
• Neuropathic Pain Symptoms Inventory — Change from Baseline at 6 months
• ISCI Basic Pain dataset version2 — Change from Baseline at 6 months
• Pain Diagram — Change from Baseline at 6 months
• Quantitative Sensory Testing — Change from Baseline at 6 months

Countries

United States