Stem Cells in Spinal Cord Injury

NCT ID: NCT03935724

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2024-08-01

Brief Summary

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

Detailed Description

Phase II of the study focuses on establishing the safety and efficacy of the fist-in-human administration of Neuro-Cells. In phase III efficacy and safety will be further investigated. Enrollment in phase III of the study will automatically start once all patients have been enrolled and treated in phase II. The recruitment period is estimated at respectively 6 months for both the Phase II and Phase III.

Phase II starts with the enrollment of 16 evaluable patients, randomly divided in two groups of 8 evaluable patients each. After an interim intervention analysis, the phase II study expands into a phase III study, requiring the recruitment of 54 additional evaluable patients. Patients recruited for the phase III part will be randomly divided in two groups of 27 evaluable patients each. Details on the planned analyses can be found in section 8 'Statistical Analysis'.

Both the phase II and phase III part of the trial have a similar setup which includes a screening period (1 - 2 days), a randomization, a treatment period of 1 or 2 days and a total follow-up period of 1 year.

All patients undergo a BM harvesting at the start of their participation in the study and will undergo three LPs, performed to administer Neuro-Cells or placebo and/or to collect CSF for research purposes. Neuro-Cells and placebo are both administered as a single dose by an 'unblinded physician'. This physician is different from the 'blinded Investigators and study nurses' responsible for patient selection and follow-up. This study set-up allows to maintain a double-blind status of the patients and the Investigators responsible for the patients' evaluation throughout the first six months of both studies. This is because, approximately six months after the time of inclusion, the patients assigned to the placebo group will undergo a second BM harvesting and will also receive Neuro-Cells. All patients are followed up until approximately one year after the time of inclusion. All patients will have been treated with Neuro-Cells and will have completed follow-up for at least 6 months post-treatment. Patient recruitment, randomization and blinding, and the primary and secondary objectives are identical in the phase II and the phase III part of the study. The study is completed when the last patient finishes his/her last visit, approximately one year after the time of inclusion.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1A Intervention group 8 patients

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

Group Type: EXPERIMENTAL

Neuro-Cells

Intervention Type: 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.

1B Placebo group 8 patients

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

Group Type: PLACEBO_COMPARATOR

Neuro-Cells

Intervention Type: 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.

2A Intervention group 27 patients

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

Group Type: EXPERIMENTAL

Neuro-Cells

Intervention Type: 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.

2B Placebo group 27 patients

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

Group Type: PLACEBO_COMPARATOR

Neuro-Cells

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroplast

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Oliviero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nacional de Parapléjicos de Toledo

Fin Biering-Soerensen, MD

Role: PRINCIPAL_INVESTIGATOR

Righospitalet

Locations

Rigshospitalet

Copenhagen, , Denmark

Hospital Nacional de Parapléjicos

Toledo, , Spain

Countries

Denmark; Spain

Related Links

https://www.neuroplast.com/

Website Neuroplast

Other Identifiers

A2017SCI03

Identifier Type: -

Identifier Source: org_study_id