Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01586312|
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : November 6, 2014
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Arthritis of Knee Knee Osteoarthritis||Other: Allogenic mesenchymal stromal cells injection Drug: Hyaluronic Acid||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid|
|Study Start Date :||April 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||June 2014|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|