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Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

NCT05054803 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-01-24

No results posted yet for this study

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

Interventions

DRUG

WJ-MSC (XCEL-UMC-BETA)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Institut Guttmann

    collaborator OTHER

  • Academic Research Organization (ARO) - VHIR

    collaborator UNKNOWN

  • Complexo Hospitalario Universitario de A Coruña

    collaborator OTHER

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Joan VIDAL, MD, PhD · Institut Guttmann

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2024-01-20
Completion
2024-01-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05054803 on ClinicalTrials.gov