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Multicenter Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis.

NCT05086939 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-11-29

No results posted yet for this study

Summary

Phase III, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.

Conditions

Interventions

DRUG

Autologous MSCs

Intra-articular injection 40 million/4 ml.

DRUG

Allogenic MSCs

Intra-articular injection 40 million/4 ml.

DRUG

Hyaluronic Acid

Intra-articular injection 60mg / 3 ml .

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

    lead OTHER

Principal Investigators

  • Fermín Sánchez-Guijo · IBSAL - University Hospital of Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05086939 on ClinicalTrials.gov