Clinical study of the effectiveness and safety of an autologous stem cell product (Neuro-Cells) in patients with a (sub) acute spinal cord injury.
- Conditions
- Traumatic Spinal cord injuryTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000805-22-ES
- Lead Sponsor
- europlast BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
1. Age range: 18 - 65 years
2. Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of
enrolment
3. Randomization can be done within 36-56 days (6-8 weeks) after the TSCI incident
4. Level of injury between C6 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
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 C6 or below T12
4. Positive HIV, hepatitis B or C serology
5. Positive Lues test
6. Total Nuclear Cell (TNC) count <1x109 TNC in bone marrow sample
7. 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
8. 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)
9. Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g., heroin, cocaine, XTC)
10. Individuals that belong to vulnerable population groups
11. 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
12. 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
13. Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
14. Patients who are unable to comply with the requirements of this clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method