AUTOLOGOUS BONE MARROW-DERIVED MESENCHYMAL STEM CELLS for Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"- Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis.\n- Chronic painful knee with mechanical features.\n- Absence of local or systemic septic process.\n- Haemacytometric and biochemical analyses without significant alterations contraindicating treatment.\n- Written informed consent obtained from the patient.\n- The patient is able to understand the nature of the study.\n- Body Mass Index between 20 and 35 kg/m2."}

Exclusion criteria

• {"criterion_text":"- Patient < 18 years old, or legally dependent.\n- Patient > 75 years old.\n- Congenital or evolutive diseases that result in malformation and/or significant deformities of the knee (varus<10º; valgus<20º) and cause difficulties in the application and evaluation of the results.\n- Pregnant or breastfeeding women.\n- Neoplastic disease\n- Intra-articular infiltration of any drug within 3 months prior to inclusion in the study.\n- Concurrent participation in another clinical trial or treatment with another investigational product in the 30 days prior to inclusion in the study.\n- Allergy to gentamicin (antibiotic used in the cell culture process).\n- Other illnesses or circumstances that might compromise the patient participation in the study according to medical criteria."}

Primary endpoints

• {"endpoint_text":"- Measurement of pain intensity according to the VAS pain scale at 12 months.","definition_or_measurement_approach":"Pain intensity measured using the Visual Analog Scale (VAS) at 12 months."}
• {"endpoint_text":"- Assessment of functional capacity and pain according to the Lequesne scale at 12 months","definition_or_measurement_approach":"Functional capacity and pain assessed using the Lequesne scale at 12 months."}
• {"endpoint_text":"- Measurement of symptomatology and perceived physical disability according to the WOMAC scale at 12 months.","definition_or_measurement_approach":"Symptoms and perceived physical disability measured using the WOMAC scale at 12 months."}
• {"endpoint_text":"- Estimation of lesion improvement or stabilisation on T2-mapping MR images at 12 months.","definition_or_measurement_approach":"Lesion improvement or stabilization assessed by T2-mapping MRI at 12 months."}

Secondary endpoints

• {"endpoint_text":"- Assessment of perceived quality of life on the SF-12 scale at 6, 12 and 24 months.","definition_or_measurement_approach":"Quality of life measured using the SF-12 questionnaire at 6, 12 and 24 months."}
• {"endpoint_text":"- Rate of products not complying with the validation criteria in each experimental treatment branch.","definition_or_measurement_approach":"Proportion of manufactured products failing validation criteria in each treatment arm."}
• {"endpoint_text":"- Rate of autologous products that could not be manufactured due to alterations in the serological profile of the patients.","definition_or_measurement_approach":"Proportion of autologous products not manufacturable because of patient serological profile alterations."}
• {"endpoint_text":"- Rate of medication-related adverse effects in each of the treatment arms.","definition_or_measurement_approach":"Incidence of treatment-related adverse events in each arm."}

Other endpoints

• {"endpoint_text":"- Cell product studies. In this exploratory objective, genomic studies will be performed by RNA-seq and open array on the advanced therapy drugs manufactured in the study (both autologous and allogeneic), and a correlation will be made with clinical and biological parameters and response, but they are not included in the explicit secondary variables, because they will also require subsequent validation.","definition_or_measurement_approach":"Exploratory genomic studies (RNA-seq and open array) on cell therapy products with correlation to clinical and biological response; results require subsequent validation."}
• {"endpoint_text":"- Biological studies to evaluate the immune system in the patient's blood and serum (days +7 and +30) As these are exploratory objectives, statistical analyses of correlations between the results of the biological variables and the clinical parameters will be carried out, but they are not included among the explicit secondary variables, because they will also require subsequent validation.","definition_or_measurement_approach":"Exploratory immune system assessments in blood and serum at days +7 and +30 with correlation analyses to clinical parameters; results are exploratory and require validation."}

Spain

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

30-04-2025

Processing Time Days

195

Number Of Sites

8

Number Of Participants

120

Primary sponsor

Full Name

Fundacion De Investigacion Biomedica De Salamanca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III","duties_or_roles":"Source of monetary support","organisation_type":""}