Back to resultsSafety Stem Cells in Spinal Cord Injury (SSCiSCI)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Neuro-Cells
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Traumatic Spinal Cord Injury, Stem Cells
Eligibility Criteria
Inclusion Criteria:
- Age range: 18 - 40 years
- Complete (AIS grade A) or incomplete (AIS grade B) TSCI (ISNCSCI-assessed) at time of recruitment
- Level of injury between C5 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
- Allergic to mice antibodies and/or iron-dextran
- Level of SCI above C5 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
- 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 vulnerable population groups
- 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
- 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
- Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
- Patients who are unable to comply with the requirements of this clinical trial
Sites / Locations
- Hospital Nacional de Parapléjicos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neuro-Cell group
Arm Description
Patient receives treatment once at start of study and followed up for safety.
Outcomes
Primary Outcome Measures
Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist
checklist in which the physician focusses on the spinal cord
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood
Measuring biochemical blood variables
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by urine
Measuring biochemical urine variables
Characterize and confirm safety of intrathecal administration of Neuro-Cells by adverse events
Severity of adverse events (if applicable)
Secondary Outcome Measures
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.
The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score
Change in the ASIAss from baseline at 3 months, 12 months and 24 months. Higher score means more change.
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
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04205019
Brief Title
Safety Stem Cells in Spinal Cord Injury
Acronym
SSCiSCI
Official Title
A 3 Months Open Phase I Study to Assess the Safety of the Intrathecal Application of Neuro-Cells in End Stage (Chronic) Traumatic Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 14, 2020 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuroplast
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Traumatic Spinal Cord Injury, Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuro-Cell group
Arm Type
Experimental
Arm Description
Patient receives treatment once at start of study and followed up for safety.
Intervention Type
Biological
Intervention Name(s)
Neuro-Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist
Description
checklist in which the physician focusses on the spinal cord
Time Frame
3 months
Title
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood
Description
Measuring biochemical blood variables
Time Frame
3 months
Title
Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by urine
Description
Measuring biochemical urine variables
Time Frame
3 months
Title
Characterize and confirm safety of intrathecal administration of Neuro-Cells by adverse events
Description
Severity of adverse events (if applicable)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The effect of late administration of Neuro-Cells by change in American Spinal Injury Association motor scale score
Description
Change in the ASIAms score from baseline at 3 months, 12 months and 24 months. Higher score means more change.
Time Frame
24 months
Title
The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score
Description
Change in the ASIAss from baseline at 3 months, 12 months and 24 months. Higher score means more change.
Time Frame
24 months
Title
Investigate the effect of Neuro-Cells on the autonomic neurological dysfunction
Description
International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement
Time Frame
24 months
Title
The effect of Neuro-Cells on the sensory neurological dysfunction
Description
International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement
Time Frame
24 months
Title
The effect of Neuro-Cells on the daily activity level as measured by the Pain basic data set
Description
Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician.
Time Frame
24 months
Title
The effect of Neuro-Cells on change in pain assessed by the pain basic data set scale.
Description
Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician.
Time Frame
24 months
Title
The effect of Neuro-Cells on pain-reducing medication by looking at change in prescribed medication
Description
Documentation of concomitant medication and the change in prescriptions. Lower dose, less medication is bigger effect.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range: 18 - 40 years
Complete (AIS grade A) or incomplete (AIS grade B) TSCI (ISNCSCI-assessed) at time of recruitment
Level of injury between C5 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
Allergic to mice antibodies and/or iron-dextran
Level of SCI above C5 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
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 vulnerable population groups
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
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
Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
Patients who are unable to comply with the requirements of this clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes P de Munter, MSc
Organizational Affiliation
CEO Neuroplast
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Nacional de Parapléjicos
City
Toledo
State/Province
Castilla La Mancha
ZIP/Postal Code
45004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://062a517c-8890-4012-ae04-9f771a08c58d.filesusr.com/ugd/6064f5_f22feb9cc2d9412596823d092a3b119c.pdf
Description
Neuroplast Press Release Primary Safety Results
Learn more about this trial
Safety Stem Cells in Spinal Cord Injury
We'll reach out to this number within 24 hrs