Safety Stem Cells in Spinal Cord Injury

NCT04205019 | Completed Phase 1 DMC

• 1 other identifier: A2019SCI04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Keywords

Traumatic Spinal Cord Injury; Stem Cells

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• The effect of late administration of Neuro-Cells by change in American Spinal Injury Association motor scale score

  24 months

• The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score

  24 months

• Investigate the effect of Neuro-Cells on the autonomic neurological dysfunction

  24 months

• The effect of Neuro-Cells on the sensory neurological dysfunction

  24 months

• The effect of Neuro-Cells on the daily activity level as measured by the Pain basic data set

  24 months

Study Arms (1)

Neuro-Cell group

EXPERIMENTAL

Patient receives treatment once at start of study and followed up for safety.

Biological: Neuro-Cells

Interventions

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.

Neuro-Cell group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuroplast: lead

Study Sites (1)

Hospital Nacional de Parapléjicos

Toledo, Castille-La Mancha, 45004, Spain

Location

Related Links

• Neuroplast Press Release Primary Safety Results

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Johannes P de Munter, MSc

  CEO Neuroplast

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 19, 2019
• Study Start: November 14, 2020
• Primary Completion: June 18, 2021
• Study Completion: March 10, 2023
• Last Updated: March 28, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)