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Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells

NCT01183728 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-01-15

Study results available
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Summary

In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.

Conditions

Interventions

OTHER

Autologous bone marrow mesenchymal stem cells (MSV)

Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.

Sponsors & Collaborators

  • Fundacion Teknon, Centro Medico Teknon, Barcelona

    collaborator UNKNOWN

  • University of Valladolid

    collaborator OTHER

  • Centro en Red de Medicina Regenerativa de Castilla y Leon

    collaborator OTHER

  • Institut de Terapia Regenerativa Tissular

    collaborator OTHER

  • EGARSAT Suma Intermutual, Barcelona, Spain

    collaborator UNKNOWN

  • Cetir Sant Jordi, S.a..

    collaborator INDIV

  • Red de Terapia Celular

    lead INDUSTRY

Principal Investigators

  • Luis Orozco, MD, PhD · Fundacion Teknon

  • Ana Sanchez, MD, PhD · IBGM, University of Valladolid

  • Robert Soler, MD · Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon

  • Javier Garcia-Sancho, MD, PhD · IBGM, University of Valladolid

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-08-31
Completion
2014-09-30

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 NCT01183728 on ClinicalTrials.gov