The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.
None
None
Parallel
INMUNOCEM
Biological/VaccineMesenchymal Stromal Cell suspension intraarticularly injected
PLACEBO COMPARATOR
DrugAdministration of plasmalyte as a vehicle for MSC
Changes in Visual Analogue scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions. Score ranges from 1 to 10, where 1 means lowest pain and 10 relates to highest pain
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS reflects the individual disease burden and overall joint health. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0)
MOCART score was introduced based on 7 pertinent variables that facilitate a standardized, reproducible, semiquantitative approach for the morphological assessment of cartilage repair. Variables assesed in MOCART are: 1. Degree of cartilage defect; 2. integration into adjacent cartilage; 3. surface of the repair tissue; 4. structure of the repair tissue; 5. signal intensity of repaired tissue; 6. bony defect or bony overgrowth; 7. subchondral changes. The score ranges between 0 and 100, being 100 the maximum level of tissue compromise
Click on the lead sponsor to view all of their trials.
GUSTAVO SALGUERO
Lead sponsor
Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
Sponsor institution
Hospital Infantil Universitario de San Jose
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
