Intradiscal injection of stem cells for chronic low back pain

Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem/Stromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial

This study is testing whether injecting stem cells into the discs of the spine can help people with chronic low back pain feel better and improve their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico (other)
• Locations: 1 site (Roma, Italy)
• Trial ID: NCT05066334 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the efficacy of injecting autologous bone marrow-derived mesenchymal stem cells (BM-MSC) into the intervertebral discs of patients suffering from chronic low back pain due to multilevel lumbar intervertebral disc degeneration. The study is randomized, controlled, and double-blinded, comparing the effects of the stem cell treatment against a sham procedure. Participants will be monitored for 24 months to assess pain relief, functionality, and quality of life using validated scales. The trial aims to provide a potential restorative treatment for a condition that currently lacks effective long-term solutions.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic low back pain due to moderate intervertebral disc degeneration unresponsive to conventional therapies for at least six months.

Not a fit: Patients with intact annulus fibrosus or those who have not experienced chronic low back pain for the required duration may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic low back pain and improve quality of life for patients with intervertebral disc degeneration.

How similar studies have performed: While stem cell therapies for intervertebral disc degeneration are still emerging, preliminary studies have shown promising results, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Signed informed consent.
* Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant.
* Annulus fibrosus intact, demonstrated by MRI.
* Pain baseline \> 40 mm on VAS (0- 100).
* NSAID washout of at least 2 days before screening.
* Painkillers washout of at least 24 hours before screening.
* For females of childbearing potential, 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. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.

Exclusion Criteria:

* Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).
* Spinal segmental instability assessed by dynamic X-Ray.
* Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy 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
* Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) in the lumbar spine.
* 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 II and III 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 m\^2) 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 amino transferase \[ALT\] 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 × 10\^9/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.
* 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.

Where this trial is running

Roma, Italy

• Campus Bio-Medico University of Rome — Roma, Italy, Italy (RECRUITING)

Study contacts

• Principal investigator: Gianluca Vadalà, MD, PhD — Campus Bio-Medico University of Rome
• Study coordinator: Gianluca Vadalà, MD, PhD

Conditions: Intervertebral Disc Degeneration, Chronic Low-back Pain, Low Back Pain, Spine, Mesenchymal Stem Cells, Bone Marrow