Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

NCT05054803 | Completed Phase 1

• 1 other identifier: BST-SCI-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.

Conditions

Spinal Cord Injury Cervical

Keywords

spinal cord injury; Mesenchymal stromal cells; Wharton jelly; Cell therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Adverse events

  At 12 month follow-up

Secondary Outcomes (15)

• American Spinal Injury Association (ASIA) impairment scale

  At 1, 3, 4, 6 and 12 month follow-up

• Motor evoked potentials

  At 6 and 12 month follow-up

• Somatosensory evoked potentials

  At 6 and 12 month follow-up

• Electrical pain threshold perception

  At 6 and 12 month follow-up

• Handgrip Strength

  At 6 and 12 month follow-up

Study Arms (2)

WJ-MSC (XCEL-UMC-BETA)

EXPERIMENTAL

Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.

Drug: WJ-MSC (XCEL-UMC-BETA)

Placebo

PLACEBO COMPARATOR

Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin

Drug: Placebo

Interventions

WJ-MSC (XCEL-UMC-BETA) DRUG

Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months

Also known as: Tested product

WJ-MSC (XCEL-UMC-BETA)

Placebo DRUG

Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single spinal cord injury lesion caused by trauma
• Affected cord segments between C1 and T1, confirmed by magnetic resonance
• Incomplete lesion (ASIA B, C or D)
• Chronic disease state (between 1 and 5 years after the injury)
• Patients from 18 to 70 years of age, both sexes
• Life expectancy \> 2 years
• Residence near the center during study participation and confidence that the patient will attend the follow-up visits
• Given informed consent in writing
• Patient is able to understand the study and its procedures

You may not qualify if:

• Mechanic ventilation
• Penetrating trauma affecting the spinal cord
• Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
• Planned spinal surgery within subsequent 12 month after entering the trial
• Neurodegenerative diseases
• Significant abnormal laboratory tests that contraindicates patient's participation in the study
• Neoplasia within the previous 5 years, or without complete remission
• Patient with communication difficulties
• Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
• Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
• Contraindication for lumbar punction
• Contraindication or inability to follow a rehabilitation program
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
• The patient does not accept to be followed-up for a period that could exceed the clinical trial length

Sponsors & Collaborators

• Banc de Sang i Teixits: lead
• Institut Guttmann: collaborator
• Academic Research Organization (ARO) - VHIR: collaborator
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (2)

Hospital de Neurorehabilitació Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, 15006, Spain

Location

Related Publications (1)

• Albu S, Kumru H, Coll R, Vives J, Valles M, Benito-Penalva J, Rodriguez L, Codinach M, Hernandez J, Navarro X, Vidal J. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021 Feb;23(2):146-156. doi: 10.1016/j.jcyt.2020.08.008. Epub 2020 Sep 25.

  PMID: 32981857 BACKGROUND

Related Links

• Blood and tissue bank of Catalonia, cell producer and sponsor of the trial
• Hospital specialized in spinal cord injury
• Hospital specialized in spinal cord injury

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

• Joan VIDAL, MD, PhD

  Institut Guttmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active treatment and placebo will be released using the same syringe and blinded in a way that it is no possible to distinguish one to the other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: October 13, 2021
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)