Clinical Trials in Spain / NCT05086939
Active, not recruiting
Phase 3
Multicenter Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis.
NCT05086939 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Knee Osteoarthritis
Investigational drug(s) / intervention(s)
Autologous MSCs: Intra-articular injection 40 million/4 ml.
Allogenic MSCs: Intra-articular injection 40 million/4 ml.
Hyaluronic Acid: Intra-articular injection 60mg / 3 ml .
Study summary
Phase III, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.
Eligibility
Inclusion Criteria:
1. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren \& Lawrence, 1957) assessed by two observers.
2. Chronic painful knee of mechanical characteristics.
3. Absence of local or systemic septic process.
4. Hemat imetric and biochemical analysis without significant alterations that contraindicate the treatment.
5. Written informed consent of the patient.
6. The patient is able to understand the nature of the study.
7. Body Mass Index 20-35 Kg/m2.
Exclusion Criteria:
1. Patient \< 18 years old, or legally dependent.
2. Patient \> 75 years old.
3. Congenital or developmental diseases that translate malformation and / or significant deformations of the knee (varus\>10º; valgus\>20º) and condition difficulties of application and evaluation of the results.
4. Pregnant or breastfeeding women.
5. Neoplastic disease.
6. Intra-articular infiltration of any drug in the 3 months prior to study inclusion.
7. Concurrent participation in another clinical trial or treatment with another investigational product within 30 days prior to study enrollment.
8. Allergy to gentamicin (antibiotic used in the cell culture process ).
9. Other diseases or circumstances that compromise participation in the study according to medical criteria.
Primary outcome measure(s)
- Range of motion. — 12 months
Evaluation of clinical-functional response using Joint range-of-motion evaluation (Flexion score 0º-140º / Extension score -140º-0º / Hyperextension: positive degrees from 0). - Pain self-assessment. — 12 months
Evaluation of pain using Visual Analogue Scale (VAS) (Pain self-assessment score range from 0 -no pain- to 10 -maximum-). - Knee Osteoarthritis. — 12 months
Evaluation of Knee Osteoarthritis using Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) \[measures five items for pain (score range from 0 -no pain- to 20 -maximum-), two for stiffness (score range from 0-no stiffness- to 8 -maximum-), and 17 for functional limitation (score range from 0 -no limitation- to 68 -maximum-)\] - Functional response. — 12 months
Evaluation of functional response using Lequesne Algofunctional Index (score range from 0 to 24). It includes measures of pain (5 questions), walking distance (1 question) and activities of daily living (4 questions) with separate versions for the hip and knee. The scores for each question are summed to obtain a combined score of disease severity. Scores 1 to 4 are classified as mild osteoarthrosis; 5 to 7, moderate; 8 to 10, severe; 11 to 13, very severe; and 14 and above, extremely severe. - X-ray changes of osteoarthritis. — 12 months
Radiological response using Kellgren and Lawrence classification system (grade from 0 to 4): * grade 0 (none): definite absence of x-ray changes of osteoarthritis. * grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping. * grade 2 (minimal): definite osteophytes and possible joint space narrowing. * grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends. * grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends. - Radiological response using nuclear magnetic resonance imaging. — 12 months
Evaluation of radiological response using T2 mapping nuclear magnetic resonance imaging (screening visit global mean of T2 values versus 12 months visit global mean of T2 values).
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Clinic | Barcelona | Spain | |
| Hospital Clínico Universitario San Carlos | Madrid | Spain | |
| Hospital Fundación Jiménez Díaz | Madrid | Spain | |
| Hospital Gregorio Marañón | Madrid | Spain | |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Spain | |
| Clínica Universidad de Navarra | Pamplona | Spain | |
| Complejo Asistencial Universitario de Salamanca | Salamanca | Spain |
More Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León trials in Spain
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05086939 on ClinicalTrials.gov ↗ ← All trials in Spain