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Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally. TSCI is a rare disease without cure perspectives and Neuro-Cells is an autologous fresh stem cells containing product (one batch / one patient).
This phase I clinical study is an open clinical trial to investigate the safety of the intrathecal application of Neuro-Cells in the treatment of end stage (chronic), traumatic complete (AIS grade A) and incomplete (AIS grade B/C) SCI patients. To that purpose, after inclusion in this study >1 year and less than 5 years after their SCI-event, 10 patients will be included. All patients are invited to visit the trial hospital every month during this 3-months study for appreciation of their possible (S)AEs and/or SUSARs, for physical examination and a biochemical analysis of their blood/urine. Day 0 and day 90 they also undergo a comprehensive neurological examination, the AISIAms, ASIAss and Pain perception.
Finally, the participants are also invited to undergo neurological examinations at day 360 and 720. The purpose of this neurological assessment is to explore in patients if a late administration of Neuro-Cells may have some beneficial effects on the neurological condition of the chronic SCI patient.
All patients undergo a BM harvesting at the start of their participation in the study and will undergo one LP, performed to administer Neuro-Cells. The study is open and descriptive, and no randomization takes place. All patients are followed up until approximately 3 months after the time of administration. After these 3 months, the safety part of this study ends. Patients are invited for a neurological assessment 9 months later (day 360) to explore if Neuro-Cells may have a beneficial effect when given to end stage patients with a traumatic SCI.
The safety part of the study is completed when the last patient finishes his/her visit at day 90. The explorative part of the study ends approximately one year after the time of inclusion at day 720.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuro-Cell group | Experimental | Patient receives treatment once at start of study and followed up for safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro-Cells | Biological | Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist | checklist in which the physician focusses on the spinal cord | 3 months |
| Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood | Measuring biochemical blood variables | 3 months |
| Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by urine | Measuring biochemical urine variables | 3 months |
| Characterize and confirm safety of intrathecal administration of Neuro-Cells by adverse events | Severity of adverse events (if applicable) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of late administration of Neuro-Cells by change in American Spinal Injury Association motor scale score | Change in the ASIAms score from baseline at 3 months, 12 months and 24 months. Higher score means more change. | 24 months |
| The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes P de Munter, MSc | CEO Neuroplast | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional de Parapléjicos | Toledo | Castille-La Mancha | 45004 | Spain |
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| Label | URL |
|---|---|
| Neuroplast Press Release Primary Safety Results | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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TSCI patients are treated once at start of the study and followed up for 3 months to characterize and confirm safety of intrathecal administration of Neuro-Cells.
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|
Change in the ASIAss from baseline at 3 months, 12 months and 24 months. Higher score means more change. |
| 24 months |
| Investigate the effect of Neuro-Cells on the autonomic neurological dysfunction | International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement | 24 months |
| The effect of Neuro-Cells on the sensory neurological dysfunction | International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement | 24 months |
| The effect of Neuro-Cells on the daily activity level as measured by the Pain basic data set | Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician. | 24 months |
| The effect of Neuro-Cells on change in pain assessed by the pain basic data set scale. | Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician. | 24 months |
| The effect of Neuro-Cells on pain-reducing medication by looking at change in prescribed medication | Documentation of concomitant medication and the change in prescriptions. Lower dose, less medication is bigger effect. | 24 months |
| D014947 | Wounds and Injuries |