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Mesenchymal Stromal Cells for Degenerative Meniscus Injury

NCT02033525 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-01-09

No results posted yet for this study

Summary

The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

Conditions

  • Chronic Meniscal Injury

Interventions

DRUG

XCEL-M-ALPHA and standard rehabilitation

Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)

OTHER

Rehabilitation

Standard rehabilitation program

Sponsors & Collaborators

  • Hospital Universitari Quirón Dexeus

    collaborator UNKNOWN

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Joan Carles Monllau, MD, PhD · ICATME-Hospital Quiron Dexeus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-05-02
Completion
2017-05-02

Countries

  • Spain

Study Locations

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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 NCT02033525 on ClinicalTrials.gov