Paraplegic disorders
Conditions
Interventions
None listed
Sponsors
Neuroplast BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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;
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameters are the by the Pinciple Investigator reported complaints (Adverse events, serious adverse events) and the changes found during the physical and neurological assessments completed with the eventual changes in biochemical parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters are the changes in ASIA scores, the autonomic functions, the SCIM III and the pain/spasm/bowel/bladder functioning questionnaires, change in medication related to pain and spasm and the experienced qualkity of life. The items mentioned before are compared between day 1 and day 90. (The neurological outcomes, questionnaires inclusive are eventual also compared with the results of day 360). The eventual changes of the spinal canal of MRI results are compared between day 1 and day 90. | — |
Countries
Netherlands
Outcome results
None listed