Clinical trial NCT05086939: 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.
Official title: Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Spanish Clinical Research Network - SCReN
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Hospital Universitari de Bellvitge
First posted: 2021-10-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Open-label, Clinical Trial comparing 3 active treatments.
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Range of motion.
timeFrame: 12 months
measure: Pain self-assessment.
timeFrame: 12 months
measure: Knee Osteoarthritis.
timeFrame: 12 months
measure: Functional response.
timeFrame: 12 months
measure: X-ray changes of osteoarthritis.
timeFrame: 12 months
measure: Radiological response using nuclear magnetic resonance imaging.
timeFrame: 12 months
Secondary outcomes:
measure: Perceived general well-being.
timeFrame: 6, 12 and 24 months
measure: Feasibility assessment of a multicentre strategy production of both cell types with several Cell Production Units
timeFrame: 24 months
measure: Evaluation of presence of adverse events related with investigational medical product (IMP).
timeFrame: 24 months
measure: Evaluation of products obtained by genomic study and potency studies of the final products of all cell types (exploratory objective)
timeFrame: 30 days
measure: Evaluate induced changes in circulating cells of the immune system after cell treatment (exploratory objetive)
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
Study officials:
affiliation: IBSAL - University Hospital of Salamanca
name: Fermín Sánchez-Guijo
role: PRINCIPAL_INVESTIGATOR
References: