In short
Clinical trials are studying ALLOGENEIC VIABLE WHARTON'S JELLY-DERIVED MESENCHYMAL STEM CELLS, EX-VIVO EXPANDED in people with chronic traumatic spinal cord injury. The trial looks at safety, feasibility, and early signs of benefit when the cells are used with neurorehabilitation and transcutaneous spinal cord stimulation. The main goal is to see whether this combined approach can be delivered safely and practically.
Key points
- Clinical trials are studying ALLOGENEIC VIABLE WHARTON'S JELLY-DERIVED MESENCHYMAL STEM CELLS, EX-VIVO EXPANDED in people with chronic traumatic spinal cord injury. The available trial is a small Phase 1 pilot study with 10 participants and is authorised. It is designed to assess safety and feasibility, not to give final proof of benefit. Researchers are tracking adverse events, physical exams, vital signs, laboratory data, and possible immune reactions in cerebrospinal fluid. The study also checks motor, sensory, and autonomic function and looks at how well the combined treatment can be carried out in real life.
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. It is an interventional study and has the status Authorised.
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. The trial is small and plans to include 10 participants.
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. The cell treatment is combined with intensive neurorehabilitation and transcutaneous spinal cord stimulation (tSCS), a stimulation method delivered through the skin over the spine.
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. With only 10 planned participants, this is a very small early study rather than a large confirmatory trial.
Outcomes and endpoints
The main outcome is safety, measured through adverse events, physical examination, vital signs, and laboratory data. Adverse events are unwanted medical problems that happen during the study, and serious adverse events are highlighted separately.
The study also tracks possible changes in motor, sensory, and autonomic function using validated tools such as the ASIA Scale and specific neurophysiological tests. These measures help show whether movement, feeling, or automatic body functions change during the study.
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. They will also monitor the whole procedure for complications linked to the combined treatment.
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. In this trial, feasibility is just as important as safety because the treatment combines several complex steps.