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

NCT03003364 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-02-17

No results posted yet for this study

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

Interventions

DRUG

XCEL-UMC-BETA

Intrathecal allogeneic cell therapy in a blinded syringe

DRUG

Placebo

Placebo in a blinded syringe

Sponsors & Collaborators

  • Hospital de Neurorehabilitació Institut Guttmann

    collaborator UNKNOWN

  • Recerca Clínica S.L.

    collaborator INDUSTRY

  • Syntax for Science, S.L

    collaborator INDUSTRY

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Joan Vidal, MD, PhD · Hospital de Neurorehabilitació Institut Guttmann

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-27
Primary Completion
2019-07-25
Completion
2020-02-11

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 NCT03003364 on ClinicalTrials.gov