Table of Contents
- Trial overview
- Who is being studied
- What is being tested
- Study phase and size
- Outcomes and endpoints
- Safety and feasibility focus
Trial overview
The available study is a pilot trial called Guttmann NeuroRecovery, which is designed to assess the feasibility, safety, and early efficacy of a combined rehabilitation approach in chronic spinal cord injury.[1] It is an interventional study and has the status Authorised.[1]
Who is being studied
The target population is people with traumatic spinal cord injury, specifically chronic injury, meaning the injury has been present for a long time.[1] The trial is small and plans to include 10 participants.[1]
What is being tested
The study investigates ALLOGENEIC VIABLE WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS, EX-VIVO EXPANDED for intrathecal use, which means the cells are given into the space around the spinal cord.[1] The cell treatment is combined with intensive neurorehabilitation and transcutaneous spinal cord stimulation (tSCS), a stimulation method delivered through the skin over the spine.[1]
Study phase and size
This is a Phase 1 trial, which usually means the first main goal is to check safety and whether the treatment plan can be done in practice.[1] With only 10 planned participants, this is a very small early study rather than a large confirmatory trial.[1]
Outcomes and endpoints
The main outcome is safety, measured through adverse events, physical examination, vital signs, and laboratory data.[1] Adverse events are unwanted medical problems that happen during the study, and serious adverse events are highlighted separately.[1]
The study also tracks possible changes in motor, sensory, and autonomic function using validated tools such as the ASIA Scale and specific neurophysiological tests.[1] These measures help show whether movement, feeling, or automatic body functions change during the study.[1]
Safety and feasibility focus
Researchers will review cerebrospinal fluid samples to look for anti-HLA antibodies, which may suggest an immune reaction to the donated cells.[1] They will also monitor the whole procedure for complications linked to the combined treatment.[1]
Feasibility means whether the study plan can be carried out well in real life, including patient adherence, retention, and practical challenges in delivering the therapy.[1] In this trial, feasibility is just as important as safety because the treatment combines several complex steps.[1]
