A 3-months open phase I study to assess the safety of the intrathecal application of Neuro-Cells in chronic traumatic spinal cord injury patients
- Conditions
- Paraplegic disordersparalyses10041543
- Registration Number
- NL-OMON46581
- Lead Sponsor
- europlast BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
1. Age range 18-65 years;
2. Signed written informed consent;
3. Complete (AIS grade A) or incomplete (AIS grade B or C) traumatic spinal cord injury * 2 years before;
4. Sufficient number of stem cells isolated from bone marrow (> 4 million CD34+)*;
5. Viability of isolated stem cells >95%*.;
*inclusion criteria 4 and 5 are checked after bone marrow collection at Day 2, in case inclusion criteria 1 to 3 are met, and in the absence of any exclusion criteria;
1.SCI AIS grade D or E at the start of the study;
2.Actual unstable spinal cord or other serious SCI-related (cardiac, respiratory) problems;
3.Trauma-induced SCI event less than 2 years ago;
4.Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder, 5.renal or cardiac insufficiency;
6.Any concomitant treatment or medication, that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (methotrexate, cyclosporine, and corticosteroids) known to interact with the anti-inflammatory and immune-modulation actions of stem cells;
7.Actual abuse of alcohol, medicines or illicit drugs;
8.Legally protected people;
9. Females with childbearing potential without using adequate birth control methods, being pregnant or in the lactation period;
10.Participation in any clinical trial otherwise within the previous 30 days before enrolment in the trial, or simultaneous participation in such trial.;
11.Patients who are unable to comply with the rules of this clinical study;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameters are the by the Pinciple Investigator reported complaints<br /><br>(Adverse events, serious adverse events) and the changes found during the<br /><br>physical and neurological assessments completed with the eventual changes in<br /><br>biochemical parameters.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameters are the changes in ASIA scores, the autonomic<br /><br>functions, the SCIM III and the pain/spasm/bowel/bladder functioning<br /><br>questionnaires, change in medication related to pain and spasm and the<br /><br>experienced qualkity of life. The items mentioned before are compared between<br /><br>day 1 and day 90. (The neurological outcomes, questionnaires inclusive are<br /><br>eventual also compared with the results of day 360).<br /><br>The eventual changes of the spinal canal of MRI results are compared between<br /><br>day 1 and day 90.</p><br>