Efficacy of intradiscal injection of cells from the bone marrow in subjects with chronic back pain, caused by a degenerative disease affecting the vertebral disc, which does not respond to traditional therapy.

Phase 1

• Conditions: Symptomatic chronic low back pain due to a degenerative disease of the intervertebral disc; MedDRA version: 21.0Level: LLTClassification code 10070241Term: Degenerative disc diseaseSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004476-19-IT
• Lead Sponsor: IVERSITÀ CAMPUS BIO-MEDICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-26
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

- Workers ( it means subject has worked at least 2 months, even if not continuously, in the last 6 months)
- Age between 18 and 65 years.
- Signed informed consent.
- Symptomatic chronic LBP due to moderate-severe IDD [modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)] at max. 4 levels of the lumbar spine unresponsive to
conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments include NSAIDs, paracetamol, opioids and myorelaxant.
- Annulus fibrosus intact, demonstrated by MRI.
- Pain baseline > 40 mm on VAS (0- 100).
- NSAIDs washout of at least 2 days before screening.
- Painkillers washout of at least 24 hours before screening.
- For females of childbearing potential (see definitions in paragraph 6.5), a negative pregnancy test must be documented at Screening.
- Men and women should use effective contraception during treatment and for at least 24 months after BM-MSC discontinuation. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

- Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months)
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis, previous fractures of the lumbar spine).
- Spinal segmental instability assessed by dynamic X-Ray.
- Symptomatic facet joints syndrome on MRI (facet joints iperintensity and ipertrophy evaluated at coronal T2 weighted MRI).
- Prior to the screening visit, has received:
.Oral corticosteroid therapy within the previous 3 months, OR
.Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months.
- Spinal canal stenosis (Schizas score > B).
- History of spinal infection.
- Lumbar disc herniation and sciatica.
- Endplate abnormality such as Schmorl’s Nodes.
- Previous discal puncture or previous spine surgery.
- IDD with Modic IIII changes on MRI images.
- Patients not eligible to the intravertebral disc surgery.
- Patients who have the risk to undergo a surgery in the next 6 months.
- Patients with local infusion device/devices for corticosteroids.
- Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
- Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception will be maintained during treatment and until the end of relevant systemic exposure. Additional pregnancy testing will be performed at the end of relevant systemic exposure. The patients will be required to use contraception from initial treatment administration until 24 months after the last dose of study drug.
- In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5.
- Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.
- Contraindication to MRI assessed by the investigator.
- Intolerance or allergy to local anaesthesia.
- Any history of Cancer or immunodeficiency disease.
- Previous transplantation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified