None listed
Conditions
Brief summary
Low back pain (LBP) is a major health problem affecting approximately 60-80% of the adult population at some stage. LBP is the second most common reason for physician visits, and for work disability and is associated with substantial health care costs. The intervertebral disc (IVD) is the most common source of LBP, being the prime source in about 40% of complex chronic LBP presentations. Non-invasive options, such as pharmacological manipulation, exercise, physical therapy and pain management programs have limited evidence. Further, surgical interventions such as discectomy and fusion for disc degeneration have similarly limited success. Cell based therapies may offer possibilities to regenerate the IVD, restore or improve its function, leading to clinical success. Mesenchymal stem cells (MSCs) are a very attractive cell source for use in restoring the normal cellular constitution of the degenerated disc. A recent pre-clinical animal study showed that implantation of bone marrow derived MSCs to degenerative discs inhibits fibrosis/scarring, preserving mechanical properties and overall spinal function. Furthermore, a study of 10 patients with confirmed disc related LBP and injected with autologous MSCs, described rapid improvement in pain and disability at 3 months, followed by a modest improvement within 6 and 12 months after injection. Importantly, based upon current clinical trial outcomes, MSC therapy is low-risk. A recent meta-analysis of trials involving a total of 1012 participants receiving MSC therapy for various conditions , did not identify any significant adverse events other than transient fever. The primary aim of this prospective case series pilot study is to evaluate the safety, tolerability and dose efficacy of autologous mesenchymal stem cells in the treatment of internal disc disruption (IDD) resulting in LBP. A secondary aim is to determine whether MSC therapy offers disease modifying potential through the examination of structural changes using MRI. Follow-up will be conducted over 12-months.
Interventions
This study will look to prospectively assess the response of discogenic lower back pain to mesenchymal stem cell therapy using the following protocol :
- Intra-discal injection of 10million stem cells at commencement of treatment and a further injection at 6months if clinically indicated (i.e. persistent pain).
This will be a single treatment group uncontrolled case series.
Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety. The
This study will look to prospectively assess the response of discogenic lower back pain to mesenchymal stem cell therapy using the following protocol : - Intra-discal injection of 10million stem cells at commencement of treatment and a further injection at 6months if clinically indicated (i.e. persistent pain). This will be a single treatment group uncontrolled case series. Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety. The small abdominal liposuction will be performed by an appropriately qualified medical clinician. This will be a day procedure and will take up to 1 hour. Isolation and expansion of mesenchymal stem cells will be performed in a suitable certified clean room facility operated by Magellan Stem Cells. Commencement of therapy will be performed no earlier than 8 weeks after liposuction due to time taken to isolate and expand the mesenchymal stem cells. Intra-discal injections will be performed by a suitably qualified procedural clinician with a medical degree equivalent of Bachelor of Medicine & Bachelor of Surgery (MBBS). These injections will be performed under radiological guidance. The chosen disc for treatment will be determined by MRI analysis. A decision to undergo a second injection at 6months will be determined after a clinical assessment by a study doctor at 6months. Any repeat injections will use mesenchymal stem cells previously isolated, expanded and stored from the initial harvest procedure. Mesenchymal stem cell will be cryopreserved in clinical grade qualified MSC cryoprotectant media using a validated control rate freezing method and stored in liquid nitrogen until use.
Sponsors
Magellan Stem Cells
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) 18 years or older 2) Severe low back pain 3) Failure with 3 months of conservative back pain care.
Exclusion criteria
1. Age <18yrs 2. Breastfeeding (accepted contra-indication as no safety data on this population). 3. Blood disorder (accepted contra-indication as no safety data on this population) 4. Anti-coagulant therapy that cannot safely be ceased. 5. History of malignancy within 10years.
Outcome results
None listed