Multicenter, randomized and controlled clinical trial to evaluate the use of PRGF-Endoret® in the treatment of low back pain

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biotechnology Institue I Mas D S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

26 Dec 2024 → ongoing

Decision date (initial)

2024-09-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The main objective of this clinical trial is to evaluate the efficacy of PRGF in reducing pain and improving quality of life (Oswestry Scale) in patients with disc degeneration in the lumbar spine with chronic clinical manifestation, compared to conventional corticosteroid treatment at six months follow-up.

Secondary objectives 7

1. To evaluate the efficacy of PRGF in reducing pain and improving quality of life (Oswestry Scale) compared to conventional corticosteroid and anesthetic treatment at 1, 3 and 12 months follow-up.
2. To evaluate the efficacy of PRGF in reducing pain and improving quality of life (COMI scale) compared to conventional corticosteroid and anesthetic treatment at 1, 3, 6 and 12 months follow-up.
3. To evaluate the quality of life (SF-12 questionnaire) related to health or perceived health (in its two aspects, physical and mental) of patients treated with PRGF compared to conventional corticosteroid and anesthetic treatment at 1, 3, 6 and 12 months of follow-up.
4. To establish whether there are structural changes (measured by MRI) related to clinical improvement in patients in the PRGF group versus the control group at 12 months after completion of treatment.
5. To assess the safety profile of the application of PRGF infiltrations.
6. To evaluate whether PRGF treatment is cost-effective compared to conventional corticosteroid and anesthetic treatment.
7. To determine if there are biological variables that can explain the efficacy of PRGF treatment and if there are biochemical markers that correlate with the clinical efficacy of the treatments.

Conditions and MedDRA coding

Low back pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients of legal age (≥18 years).
2. Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebral disc degeneration(s) (Pfirrmann Scale > 1).
3. 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.
4. 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.
5. Numerical pain scale (COMI PAIN SCORE): between 6 and 10, average of the last month.
6. Availability of an MRI performed in the last six months to allow the diagnosis.
7. Availability of a complete blood test (hemogram, basic biochemistry and coagulation tests) performed in the last two months.
8. Signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication.
9. Commitment in the informed consent of availability for post-treatment patient follow-up (up to 12 months).

Exclusion criteria 11

1. Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded.
2. Patients with severe discopathies at levels adjacent to L4-L5 and/or L5-S1.
3. Patients who have previously undergone spinal surgery.
4. Patients with neurogenic motor claudication.
5. 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.
6. Patients who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis.
7. Patients with a history of drug use (e.g. alcoholism or others) and mental illness or marked psychological conditions related to pain.
8. Morbidly obese patients (BMI > 40 kg/m2).
9. 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.
10. 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.
11. Patients who present allergy to any component of the sedation or to the corticoid and/or anesthetic.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Evaluation of the Oswestry scale at 6 months follow-up.

Secondary endpoints 9

1. Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7).
2. Assessment of the Oswestry scale at 1, 3, and 12 months of follow-up.
3. Evaluation of the COMI scale at 1, 3, 6, and 12 months of follow-up.
4. Evaluation of the SF-12 scale at 1, 3, 6, and 12 months of follow-up.
5. 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.
6. Incidence and type of adverse events.
7. Cost-utility analysis.
8. Hematological characterization of blood and PRGF.
9. Biochemical characterization of PRGF.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biotechnology Institue I Mas D S.L.

Sponsor organisation

Biotechnology Institue I Mas D S.L.

Address

Calle San Antonio 15 5a

City

Vitoria-Gasteiz

Postcode

01015

Country

Spain

Scientific contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Public contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications