Stem Cells in Spinal Cord Injury

NCT03935724 | Unknown Phase 2 DMC

• 1 other identifier: A2017SCI03
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled and delayed-start phase II/III clinical study.

Conditions

Spinal Cord Injuries; Acute Spinal Cord Injury; Paraplegia, Spinal; Paraplegia; Traumatic

Outcome Measures

Primary Outcomes (2)

• Physical changes after intrathecal intervention with Neuro-Cells

  At approx. 3 months after intrathecal intervention with Neuro-Cells (day 90 for the patients treated 6-10 weeks after the TSCI incident and day 270 for the patients treated at 32-34 weeks after the TSCI incident) a physical examination (checklist) will be done

  9 months

• Increase of motor scores after intrathecal invervention with Neuro-Cells

  Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 2) at 6 months after the intrathecal intervention (day 180) in patients treated with Neuro-Cells

  6 months

Secondary Outcomes (2)

• Increase of motor scores after late administration of Neuro-Cells

  12 months

• Change in autonomic and sensoric neurological dysfunctionafter intrathecal invervention with Neuro-Cells

  12 months

Study Arms (4)

1A Intervention group 8 patients

EXPERIMENTAL

Neuro-Cells treatment at day 1-2 (= 6-10 weeks after TSCI incident). N=8

Biological: Neuro-Cells

1B Placebo group 8 patients

PLACEBO COMPARATOR

Placebo treatment at day 1-2 (= 6-10 weeks after TSCI incident) Neuro-Cells treatment at day 181-182 (= 32-34 weeks after TSCI incident) N=8

Biological: Neuro-Cells

2A Intervention group 27 patients

EXPERIMENTAL

Neuro-Cells treatment at day 1-2 (= 6-10 weeks after TSCI incident) N=27

Biological: Neuro-Cells

2B Placebo group 27 patients

PLACEBO COMPARATOR

Placebo treatment at day 1-2 (= 6-10 weeks after TSCI incident) Neuro-Cells treatment at day 181-182 (= 32-34 weeks after TSCI incident) N=27

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.

1A Intervention group 8 patients; 1B Placebo group 8 patients; 2A Intervention group 27 patients; 2B Placebo group 27 patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 18 - 65 years
• Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization
• Randomization can be done within 6-10 weeks after the TSCI incident
• Level of injury between C4 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
• Level of SCI above C4 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
• Patients suffering from respiratory issues that cannot breathe on their own 24/7
• 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, 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 (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hospital Nacional de Parapléjicos

Toledo, 45004, Spain

Location

Related Links

• Website Neuroplast

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Oliviero, MD

  Hospital Nacional de Parapléjicos de Toledo

  PRINCIPAL INVESTIGATOR

• Fin Biering-Soerensen, MD

  Righospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties are masked (except for the care provider administering placebo of Neuro-cells). Unmasking will occur after six months when the placebo group receives Neuro-cells.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are randomized into two groups. First groups receives Neuro-cells, second group receives placebo. After six months second group also receives Neuro-cells. This happens in phase 2 and is repeated in phase 3. Therefore there are 4 groups.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 2, 2019
• Study Start: January 18, 2022
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); ES (1)