Traumatic spinal cord injury
Conditions
Interventions
Product Name: Neuro-Cells
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intrath
Sponsors
Neuroplast BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 65 years 2. Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization 3. Randomization can be done within 6-10 weeks after the TSCI incident 4. Level of injury between C4 to T12 5. Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. SCI AIS grade D or E at the start of enrolment 2. Allergic to mice antibodies and/or iron-dextran 3. Level of SCI above C4 or below T12 4. Positive HIV, hepatitis B or C serology 5. Positive Lues test 6. Total Nuclear Cell (TNC) count in Bone Marrow sample < 1x109 TNC 7. Patients suffering from respiratory issues that cannot breathe on their own 24/7 8. Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis etc.), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator’s discretion 9. Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti-inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed) (see section 6.8) 10. Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g., heroin, cocaine, XTC) 11. Individuals that belong to vulnerable population groups 12. Females with childbearing potential without using adequate birth control methods (e.g., contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged release), subdermal implantation, vaginal ring or transdermal patches), and/or being pregnant or in the lactation period 13. Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial 14. Participants with extreme comorbidity before or after the TSCI 15. Participants who are unable to comply with the requirements of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to characterize and confirm the safety of intrathecal intervention of Neuro-Cells and to investigate the effect of early administration of Neuro-Cells (between 6 and 10 weeks after the TSCI incident) on the neurological (motor) condition of TSCI patients approx. 6 months after intrathecal intervention. This primary objective is intended to answer the question if an early intervention with Neuro-Cells does improve, and to what level, the neurological (motor) condition induced by a TSCI. ;Secondary Objective: •To investigate the effect of late administration of Neuro-Cells (between 32 and 34 weeks after the TSCI incident) on the neurological (motor) condition of TSCI patients approx. 6 months after intrathecal intervention. This secondary objective is intended to answer the question if a later intrathecal intervention with Neuro-Cells does improve, and to what level, the neurological (motor) condition induced by a TSCI. •The other secondary objectives in this study are intended to investigate the effect of Neuro-Cells on the autonomic and sensoric neurological dysfunction, daily activity level, quality of life, pain perception, spasticity, use of pain-reducing and spasticity-reducing medication of TSCI patients approximately 6 and respectively 12 months after intrathecal intervention depending on initial treatment assignment. ;Primary end point(s): Primary Safety endpoint: •Safety at approx. 3 months after intrathecal intervention with Neuro-Cells (day 90 for the patients treated 6-8 weeks after the TSCI incident and day 270 for the patients treated at 32-34 weeks after the TSCI incident) ?Physical examination status oFollowing an electronic Case Report Form (e-CRF) checklist in which the physician focusses on the spinal cord (International Standards for Neurological Classification of SCI (ISNCSCI)), the upper and lower respiratory tract, the circulation (pulse and blood pressure) and the liver, spleen and kidneys (enlargem | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy: • Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 5) at 6 months after the intrathecal intervention (day 360) in patients treated with Neuro-Cells 32 to 34 weeks after the TSCI incident as compared to placebo treated patients • In patients treated with Neuro-Cells approximately 6-8 weeks after the TSCI, the following secondary endpoints will be studied at days 180 and 360 and compared to the placebo treated patients and the baseline measurements (day 0): ? Increase in ISNCSCI sensory scores (pinprick and light touch) ? Functional outcome using SCIM III assessments (Bluvshtein et al, 2011) ? Pain perception (Widerstrom-Noga et al, 2014) and pain-reducing medication ? Spasticity measurements of the knee and hip flexor and extensor muscles using the modified Ashworth scale (MAS) (Bohannon and Smith, 1987) and actual spasticity-reducing medication ? General wellbeing 3 question items QoL (Charlifue et al, 2012) • In patients treated with Neuro-Cells approximately 32-34 weeks after the TSCI, the following secondary endpoints will be studied at days 360 and compared to the baseline measurements (day 0 and day 180): ? Increase in ISNCSCI sensory scores (pinprick and light touch) ? Functional outcome using SCIM III assessments ? Pain perception and pain-reducing medication ? Spasticity measurements of the knee and hip flexor and extensor muscles using the modified Ashworth scale (MAS) and actual spasticity-reducing medication ? General wellbeing 3 question items QoL ;Timepoint(s) of evaluation of this end point: Secondary measures will be studied at days 0, 180 and 360 of the study. Improvements in urinary and bowel functions will be studied at days 0 and 360. Safety aspects will be studied at study days 90 and 270. | — |
Countries
Denmark, Spain
Contacts
Public ContactClinical Trial Information
Neuroplast BV
Outcome results
None listed