Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

NCT ID: NCT05054803

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2024-01-20

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.

Detailed Description

Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.

Conditions

Spinal Cord Injury Cervical

Study Design

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

Study Groups

WJ-MSC (XCEL-UMC-BETA)

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

Group Type: EXPERIMENTAL

WJ-MSC (XCEL-UMC-BETA)

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

WJ-MSC (XCEL-UMC-BETA)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Tested product

Eligibility Criteria

Inclusion Criteria

1. Single spinal cord injury lesion caused by trauma

2. Affected cord segments between C1 and T1, confirmed by magnetic resonance

3. Incomplete lesion (ASIA B, C or D)

4. Chronic disease state (between 1 and 5 years after the injury)

5. Patients from 18 to 70 years of age, both sexes

6. Life expectancy > 2 years

7. Residence near the center during study participation and confidence that the patient will attend the follow-up visits

8. Given informed consent in writing

9. Patient is able to understand the study and its procedures

Exclusion Criteria

1. Mechanic ventilation

2. Penetrating trauma affecting the spinal cord

3. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding

4. Planned spinal surgery within subsequent 12 month after entering the trial

5. Neurodegenerative diseases

6. Significant abnormal laboratory tests that contraindicates patient's participation in the study

7. Neoplasia within the previous 5 years, or without complete remission

8. Patient with communication difficulties

9. 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

10. Previous treatment with and advanced Therapy Medicinal Product (cell therapy)

11. Contraindication for lumbar punction

12. Contraindication or inability to follow a rehabilitation program

13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Guttmann

OTHER

Sponsor Role: collaborator

Academic Research Organization (ARO) - VHIR

UNKNOWN

Sponsor Role: collaborator

Complexo Hospitalario Universitario de A Coruña

OTHER

Sponsor Role: collaborator

Banc de Sang i Teixits

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan VIDAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Guttmann

Locations

Hospital de Neurorehabilitació Institut Guttmann

Badalona, Barcelona, Spain

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 32981857 (View on PubMed)

Related Links

https://www.bancsang.net

Blood and tissue bank of Catalonia, cell producer and sponsor of the trial

https://www.guttmann.com/

Hospital specialized in spinal cord injury

https://xxicoruna.sergas.gal/Paxinas/web.aspx?tipo=paxtxt&idContido=595&idLista=4

Hospital specialized in spinal cord injury

Other Identifiers

BST-SCI-02

Identifier Type: -

Identifier Source: org_study_id