Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury

NCT03003364 | Completed Phase 1

• 1 other identifier: XCEL-SCI-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.

Conditions

Spinal Cord Injury, Chronic

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Adverse events

  12 months

Secondary Outcomes (14)

• Extent and severity of a patient's spinal cord injury

  6 months

• Motor electrophysiology assessment

  6 month

• Somatosensory electrophysiology assessment

  6 month

• Electrical nerve stimulation on pain perception

  6 month

• Mictional dysfunction

  6 month

Study Arms (2)

XCEL-UMC-BETA/placebo

EXPERIMENTAL

Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)

Drug: XCEL-UMC-BETA; Drug: Placebo

Placebo/XCEL-UMC-BETA

PLACEBO COMPARATOR

Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)

Drug: XCEL-UMC-BETA; Drug: Placebo

Interventions

XCEL-UMC-BETA DRUG

Intrathecal allogeneic cell therapy in a blinded syringe

Also known as: Expanded MSC from Wharton Jelly

Placebo/XCEL-UMC-BETA; XCEL-UMC-BETA/placebo

Placebo DRUG

Placebo in a blinded syringe

Placebo/XCEL-UMC-BETA; XCEL-UMC-BETA/placebo

Eligibility Criteria

• Age: 18 Years - 65 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 T2 and T11, confirmed by magnetic resonance
• Complete paraplegia (ASIA A)
• Chronic disease state (between 12 months and 5 years after the injury)
• Patients from 18 to 65 years of age, both sexes
• Life expectancy \> 2 years
• 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
• Lesion affecting multiple levels
• Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance
• Penetrating trauma affecting the spinal cord
• Positive serology to HIV, HBV, HCV and or syphilis
• Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
• Use of metal implants that complicates the MRI interpretation
• Planned spinal surgery within subsequent 24 month after entering the trial
• Intrathecal medication or immunosuppressive drugs the previous 60 days.
• 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 difficulty for communicating
• Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days
• Contraindication for lumbar punction

Sponsors & Collaborators

• Banc de Sang i Teixits: lead
• Hospital de Neurorehabilitació Institut Guttmann: collaborator
• Recerca Clínica S.L.: collaborator
• Syntax for Science, S.L: collaborator

Study Sites (1)

Hospital de Neurorehabilitació Institut Guttmann

Badalona, Barcelona, 08916, 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 DERIVED

Related Links

• Hospital de Neurorehabilitació Institut Guttmann
• Marató TV3

MeSH Terms

Conditions

Spinal Cord Injuries; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Joan Vidal, MD, PhD

  Hospital de Neurorehabilitació Institut Guttmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 28, 2016
• Study Start: December 27, 2016
• Primary Completion: July 25, 2019
• Study Completion: February 11, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)