Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)
|Osteoarthritis, Knee Arthritis of Knee Knee Osteoarthritis||Other: Allogenic mesenchymal stromal cells injection Drug: Hyaluronic Acid||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid|
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to one year ]Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
- Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores) [ Time Frame: up to one year ]
Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.
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.
SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.
The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.
LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).
All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.
Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.
- Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram) [ Time Frame: up to one year ]
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 number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.
|Study Start Date:||April 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Allogenic mesenchymal stromal cells injection
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Other: Allogenic mesenchymal stromal cells injection
Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency
Active Comparator: Hyaluronic acid (Durolane)
Intraarticular injection of hyaluronic acid (60 mg)
Drug: Hyaluronic Acid
Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
Other Name: Hyaluronic acid, durolane, CE mark:516407
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586312
|Centro Medico Teknon|
|Barcelona, Spain, 08022|
|Hospital Clinico Universitario|
|Valladolid, Spain, 47003|
|Study Chair:||Javier García-Sancho, MD, PhD||University of Valladolid, Scientific Park|
|Study Director:||Aurelio Vega, MD,PhD||Hospital Clinico Universitario, Valladolid|
|Study Director:||Luis Orozco, MD, PhD||Centro Médico Teknon, Barcelona|
|Study Director:||Ana Sanchez, MD, PhD||Director, Cell Production Unit, Parque Científico UVa|
|Study Director:||Jose M Moraleda, MD. PhD||Virgen de la Arrixaca University Hospital, Murcia, Spain|