Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (KDD&MSV)
|Osteoarthritis, Knee Knee Degenerative Disease Knee Osteoarthritis||Other: Autologous bone marrow mesenchymal stem cells (MSV)||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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)|
- Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee. [ Time Frame: 0, 3, 6, 12 and 24 months ]
Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).
In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.
VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities.
- Indication of Efficacy [ Time Frame: 0, 6, 12, 24 months ]
Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.
Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.
Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100.
|Study Start Date:||May 2010|
|Study Completion Date:||September 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: MSV autologous transplantation
Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection
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.
Other Name: MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183728
|Teknon Medical Center, ITRT|
|Barcelona, Spain, 08022|
|Instituto de Biologia y Genetica Molecular (IBGM), University of Valladolid|
|Valladolid, Spain, 47003|
|Principal Investigator:||Luis Orozco, MD, PhD||Fundacion Teknon|
|Study Director:||Ana Sanchez, MD, PhD||IBGM, University of Valladolid|
|Study Director:||Robert Soler, MD||Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon|
|Study Director:||Javier Garcia-Sancho, MD, PhD||IBGM, University of Valladolid|