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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut Guttmann

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

11 Mar 2026 → ongoing

Decision date (initial)

2026-01-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

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.

Secondary objectives 5

1. Efficacy assessment: • To measure improvements in motor, sensory, and autonomic functions by using validated tools (ASIA Scale, motor evoked potentials [MEPs], somatosensory evoked potentials [SSEPs], perception thresholds for electrical and painful stimuli, Neurogenic Bowel Dysfunction Score [intestinal dysfunction], Rome IV Criteria [constipation], and forced vital capacity [FVC]).
2. •To assess changes in functional independence, mobility, quality of life, pain levels, spasticity, and psychological well-being through physical examination and appropriate patient-reported outcome measures.
3. Neuroplasticity assessment:•To perform neurophysiological assessments, including MEPs and SSEPs, to evaluate changes in neural pathways and functional recovery.
4. •To assess segmental sensitivity levels by evaluating perception of thermal and electrical stimulation.
5. •To evaluate the extent of neuroplasticity and its role in the functional improvements observed.

Conditions and MedDRA coding

Traumatic spinal cord injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. •Single spinal cord injury of traumatic aetiology, AIS grade A-C.
2. •Confirmed diagnosis of spinal cord injury at cervical or thoracic levels (C1–T12), based on clinical evaluation and previous medical imaging records.
3. •Duration of spinal cord injury greater than 1 year post-injury.
4. •Age range: 18-70 years.
5. •Life expectancy greater than 2 years.
6. •Ability to attend follow-up visits and participate in study procedures.
7. •Written informed consent.
8. •Adequate cognitive capacities in order to understand the nature of the study and provide consent.
9. •Willingness to comply with all therapeutic protocols and study procedures.

Exclusion criteria 19

1. •Severe comorbidities that, based on the criteria of the investigator, prevent the participant from participating in the study.
2. •Individuals receiving mechanical ventilation
3. •Contraindications for tSCS ( for instance, implanted devices that may interfere).
4. •Pregnant or breastfeeding women.
5. •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.
6. •Neurodegenerative diseases.
7. •Significant haematological and biochemical abnormalities that contraindicate participation in the study.
8. •Neoplastic disease detected in the last five years or without complete remission.
9. •Positive serology for HIV, HBV, HCV and/or syphilis.
10. •Difficulties in communicating with the evaluators (language barriers, aphasia).
11. •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.
12. •Intrathecal medication or immunosuppressive drugs in the last 60 days.
13. •Spinal cord injury with injury affecting multiple levels.
14. •Contraindications for lumbar puncture.
15. •Planned spinal surgery within 24 months after enrolment in the trial.
16. •Injury length exceeding 3 spinal cord segments, as determined by magnetic resonance imaging.
17. •Contraindications or inability to follow a rehabilitation programme.
18. •Other pathologies or circumstances which might compromise the individual's participation in the study based on medical criteria.
19. •Known allergic reactions to components present in stem cell preparations.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The safety assessment will take into account adverse events (AEs), physical examination, vital signs, and laboratory data. AEs of special interest will be specifically identified. AEs will be coded using MedDRA™. All AEs will be summarized with the number and percentage of patients with an AE, as well as the number and incidence of AEs by MedDRA™. Serious AEs (SSAs) will be highlighted and listed. Safety will be assessed using descriptive statistics in the safety population.

Secondary endpoints 1

1. Continuous variables assessed repeatedly over time will be analysed using mixed models for repeated measurements (longitudinal Mixed Model for Repeated Measurements (MMRM)), which will include time as a random factor, treatment as a fixed factor, and the interaction between time and treatment. The presence or absence of anti-HLA antibodies in CSF after the first and third infusions of WJ-MSC ( weeks 1 and 9) will be estimated using a logistic regression model.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut Guttmann

Sponsor organisation

Fundacio Institut Guttmann

Address

Cami De Can Ruti S/n

City

Badalona

Postcode

08916

Country

Spain

Scientific contact point

Organisation

Fundacio Institut Guttmann

Contact name

Joan Vidal

Public contact point

Organisation

Fundacio Institut Guttmann

Contact name

Joan Vidal

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications