PLATELET CONCENTRATE for Low back pain | Intervertebral disc degeneration

Inclusion criteria

• {"criterion_text":"- Patients of legal age (≥18 years)."}
• {"criterion_text":"- Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebral disc degeneration(s) (Pfirrmann Scale > 1)."}
• {"criterion_text":"- Patients with positive signs in MRI at L4-L5 and/or L5-S1 levels, including rupture of the annulus fibrosus, annular fissure, with or without disc herniation in its protrusion form will be included."}
• {"criterion_text":"- Patients with low back pain with symptoms of low back pain for at least 3 months of evolution that has not responded to drug treatment."}
• {"criterion_text":"- Numerical pain scale (COMI PAIN SCORE): between 6 and 10, average of the last month."}
• {"criterion_text":"- Availability of an MRI performed in the last six months to allow the diagnosis."}
• {"criterion_text":"- Availability of a complete blood test (hemogram, basic biochemistry and coagulation tests) performed in the last two months."}
• {"criterion_text":"- Signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication."}
• {"criterion_text":"- Commitment in the informed consent of availability for post-treatment patient follow-up (up to 12 months)."}

Exclusion criteria

• {"criterion_text":"- Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded."}
• {"criterion_text":"- Patients with pathologies that produce marked alterations in the efficacy of PRGF or coagulation, such as, for example: poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemia with Hb < 9), being subjected to immunosuppressive and/or dicoumarinic treatments, or any treatment with systemic corticosteroids during the 6 months prior to inclusion in the study."}
• {"criterion_text":"- Patients who present allergy to any component of the sedation or to the corticoid and/or anesthetic."}
• {"criterion_text":"- Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1."}
• {"criterion_text":"- Patients who have previously undergone spinal surgery."}
• {"criterion_text":"- Patients with neurogenic motor claudication."}
• {"criterion_text":"- Patients with severe cardiovascular diseases, central nervous system diseases, epilepsy, coagulopathies, immunological diseases, infectious diseases (e.g. Hepatitis B and C, HIV, Syphilis), cancer or neurodegenerative pathologies."}
• {"criterion_text":"- Patients who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis."}
• {"criterion_text":"- Patients with a history of drug use (e.g. alcoholism or others) and mental illness or marked psychological conditions related to pain."}
• {"criterion_text":"- Morbidly obese patients (BMI > 40 kg/m2)."}
• {"criterion_text":"- Women who are pregnant or breastfeeding or women of childbearing age who are not taking effective contraceptive measures as outlined in the Clinical Trials Facilitation and Coordination Group (CTFG) \"Recommendations Regarding Contraception and Pregnancy Testing in Clinical Trials\" V 1.1."}

Primary endpoints

• {"endpoint_text":"- Evaluation of the Oswestry scale at 6 months follow-up.","definition_or_measurement_approach":"Measurement: Oswestry scale (Oswestry Disability Index) assessed at 6 months follow-up."}

Secondary endpoints

• {"endpoint_text":"- Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7).","definition_or_measurement_approach":"Percentage of treatment failures at 1, 3, 12 months; specific definition referenced in protocol section 8.7 (not provided here)."}
• {"endpoint_text":"- Assessment of the Oswestry scale at 1, 3, and 12 months of follow-up.","definition_or_measurement_approach":"Oswestry scale (Oswestry Disability Index) measured at 1, 3, and 12 months."}
• {"endpoint_text":"- Evaluation of the COMI scale at 1, 3, 6, and 12 months of follow-up.","definition_or_measurement_approach":"COMI pain/outcome questionnaire measured at 1, 3, 6, and 12 months."}
• {"endpoint_text":"- Evaluation of the SF-12 scale at 1, 3, 6, and 12 months of follow-up.","definition_or_measurement_approach":"SF-12 health-related quality of life questionnaire measured at 1, 3, 6, and 12 months."}
• {"endpoint_text":"- Radiological imaging (MRI) results. Differences at 12 months with respect to baseline determinations of the: Pfirrmann, Size of the disc herniation, Intervertebral space height (endplate to endplate) and Disc volume grade.","definition_or_measurement_approach":"MRI-based radiological outcomes: Pfirrmann grade, size of disc herniation, intervertebral space height, and disc volume grade compared baseline vs 12 months."}
• {"endpoint_text":"- Incidence and type of adverse events.","definition_or_measurement_approach":"Collection and classification of adverse events and their incidence and types during follow-up."}
• {"endpoint_text":"- Cost-utility analysis.","definition_or_measurement_approach":"Economic evaluation measuring costs and utilities (cost-utility) comparing treatments (method details in protocol)."}
• {"endpoint_text":"- Hematological characterization of blood and PRGF.","definition_or_measurement_approach":"Hematological laboratory characterization of blood and PRGF samples (parameters not detailed here)."}
• {"endpoint_text":"- Biochemical characterization of PRGF.","definition_or_measurement_approach":"Biochemical analyses of PRGF composition (details in protocol)."}

Spain

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

617

Number Of Sites

2

Number Of Participants

48

Primary sponsor

Full Name

Biotechnology Institue I Mas D S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain