Safety Stem Cells in Spinal Cord Injury (SSCiSCI)

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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Biological: Neuro-Cells

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45004
      • Hospital Nacional de Parapléjicos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age range: 18 - 40 years
2. Complete (AIS grade A) or incomplete (AIS grade B) TSCI (ISNCSCI-assessed) at time of recruitment
3. Level of injury between C5 to T12
4. Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed

Exclusion Criteria:

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 C5 or below T12
4. Positive HIV, hepatitis B or C serology
5. Positive Lues test
6. Total Nuclear Cell (TNC) count < 1x109 TNC
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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuro-Cell group; Patient receives treatment once at start of study and followed up for safety.	Biological: Neuro-Cells; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Neuroplast
• Investigators: Study Director: Johannes P de Munter, MSc, CEO Neuroplast

Publications and helpful links

Helpful Links

• Neuroplast Press Release Primary Safety Results

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2020
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stem Cells; Traumatic Spinal Cord Injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: A2019SCI04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No