Evaluation of mesenchymal stem cells for the treatment of lower back pai
Not Applicable
Completed
- Conditions
- ower Back PainLower Back PainMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12617000636358
- Lead Sponsor
- Magellan Stem Cells
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ower Back Pain : assessed using a Numeric Pain Rating Scale[ Follow-up will be conducted at baseline, 1, 3, 6, 9, 12 and 24 months.<br> - trial was extended to 24 months of follow-up with HREC approval after all participants were recruited.];Safety and Tolerability of Treatment : assessed using an Adverse Event Registry<br>Previous studies using mesenchymal stem cells have noted an initial flare up in pain. Other studies using intra-venous administration of mesenchymal stem cells have observed a self limiting fever. <br>[ Adverse events documented at 1 week, 1 month, 3month, 6month, 9month and 12month time points.<br>]
- Secondary Outcome Measures
Name Time Method Disc Structural Changes - assessed by MRI[ MRI will be conducted prior to commencement of therapy and again at 12months post therapy.]