CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Autologous bone marrow mesenchymal stem cells (MSV)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01183728
NCT01183728Phase 2Completed
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Regeneration of Articular Cartilage in Grade II, III and IV Knee Osteoarthritis by Intraarticular Injection of Autologous Bone Marrow Stem Cells Expanded ex Vivo With a GMP Procedure Developed by IBGM-Valladolid (MSV)

Red de Terapia Celular·interventional·Posted Aug 18, 2010·Updated Jan 15, 2015

In Brief

A Phase 2 clinical trial evaluating Autologous bone marrow mesenchymal stem cells (MSV) for Osteoarthritis, Knee and 2 related conditions. Completed, enrolled 12 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee, Knee Degenerative Disease, Knee Osteoarthritis
CountriesSpain
CollaboratorsFundacion Teknon, Centro Medico Teknon, Barcelona, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Institut de Terapia Regenerativa Tissular, EGARSAT Suma Intermutual, Barcelona, Spain, Cetir Sant Jordi, S.a..

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2010
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.9 years ago

Interventions

Autologous bone marrow mesenchymal stem cells (MSV)other

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.