This is a multicenter, randomized, double-blind, placebo-controlled and delayed-start phase II/III clinical study.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age range: 18 - 65 years
* Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization
* Randomization can be done within 6-10 weeks after the TSCI incident
* Level of injury between C4 to T12
* Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed
Exclusion Criteria:
* SCI AIS grade D or E at the start of enrolment
* Level of SCI above C4 or below T12
* Positive HIV, hepatitis B or C serology
* Positive Lues test
* Total Nuclear Cell (TNC) count \< 1x109 TNC
* 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
* Patients suffering from respiratory issues that cannot breathe on their own 24/7
* 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)
* Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g. heroin, cocaine, XTC)
* Individuals that belong to…
What they're measuring
1
Physical changes after intrathecal intervention with Neuro-Cells
Timeframe: 9 months
2
Increase of motor scores after intrathecal invervention with Neuro-Cells