BridgeMD
Guttmann NeuroRecovery – Feasibility, safety and efficacy of intrathecal Wharton's jelly-derived mesenchymal stem cells and transcutaneous spinal cord stimulation in the rehabilitation of chronic spinal cord injuries: a pilot study
EU CTIS ID: 2025-521877-14-00
What this study is testing
To assess the safety and feasibility of a combined therapeutic intervention involving intrathecal infusion of Wharton's jelly-derived mesenchymal stem cells and intensive neurorehabilitation with transcutaneous spinal cord stimulation (tSCS) in individuals with chronic spinal cord injury. Safety assessment: Adverse events monitoring throughout the entire procedure. To monitor unfavourable changes (worsening) in motor, sensory and autonomic functions using validated tools such as the ASIA Scale and specific neurophysiological tests. To analise cerebrospinal fluid (CSF) samples to detect anti-HLA antibodies and evaluate possible immunological reactions. To identify any complications directly associated with the combined intervention. Feasibility assessment: To assess patient adherence to the protocol in all the phases. To measure retention rates and identifying practical challenges in therapy implementation. To evaluate overall feasibility of combining these interventions in a clinical setting.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •Single spinal cord injury of traumatic aetiology, AIS grade A-C.
- •Confirmed diagnosis of spinal cord injury at cervical or thoracic levels (C1–T12), based on clinical evaluation and previous medical imaging records.
- •Duration of spinal cord injury greater than 1 year post-injury.
- •Age range: 18-70 years.
- •Life expectancy greater than 2 years.
- •Ability to attend follow-up visits and participate in study procedures.
You likely can't join if
- •Severe comorbidities that, based on the criteria of the investigator, prevent the participant from participating in the study.
- •Difficulties in communicating with the evaluators (language barriers, aphasia).
- •Simultaneous participation in other clinical trials or treatment with other investigational products within 30 days prior to inclusion in the study, which may interfere with the study results.
- •Intrathecal medication or immunosuppressive drugs in the last 60 days.
- •Spinal cord injury with injury affecting multiple levels.
- •Contraindications for lumbar puncture.
See the full eligibility criteria
- •Single spinal cord injury of traumatic aetiology, AIS grade A-C.
- •Confirmed diagnosis of spinal cord injury at cervical or thoracic levels (C1–T12), based on clinical evaluation and previous medical imaging records.
- •Duration of spinal cord injury greater than 1 year post-injury.
- •Age range: 18-70 years.
- •Life expectancy greater than 2 years.
- •Ability to attend follow-up visits and participate in study procedures.
- •Written informed consent.
- •Adequate cognitive capacities in order to understand the nature of the study and provide consent.
- •Willingness to comply with all therapeutic protocols and study procedures.
- •Severe comorbidities that, based on the criteria of the investigator, prevent the participant from participating in the study.
- •Difficulties in communicating with the evaluators (language barriers, aphasia).
- •Simultaneous participation in other clinical trials or treatment with other investigational products within 30 days prior to inclusion in the study, which may interfere with the study results.
- •Intrathecal medication or immunosuppressive drugs in the last 60 days.
- •Spinal cord injury with injury affecting multiple levels.
- •Contraindications for lumbar puncture.
- •Planned spinal surgery within 24 months after enrolment in the trial.
- •Injury length exceeding 3 spinal cord segments, as determined by magnetic resonance imaging.
- •Contraindications or inability to follow a rehabilitation programme.
- •Other pathologies or circumstances which might compromise the individual's participation in the study based on medical criteria.
- •Known allergic reactions to components present in stem cell preparations.
- •Individuals receiving mechanical ventilation
- •Contraindications for tSCS ( for instance, implanted devices that may interfere).
- •Pregnant or breastfeeding women.
- •Women with the potential to become pregnant who are not using a highly effective method of contraception, being considered ‘highly effective’ those that can achieve a failure rate of less than 1% per year when used consistently and correctly (*).(*) The effective contraceptive methods considered in the protocol are hormonal methods, intrauterine devices (IUDs), barrier methods, voluntary sterilisation, or the participant having been in menopause for more than one year.
- •Neurodegenerative diseases.
- •Significant haematological and biochemical abnormalities that contraindicate participation in the study.
- •Neoplastic disease detected in the last five years or without complete remission.
- •Positive serology for HIV, HBV, HCV and/or syphilis.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.