None listed
Conditions
Brief summary
The purpose of this study is to formally follow up and record the effectiveness of autologous (your own) stem cell injections in the treatment of arthritis. A secondary objective is to determine whether stem cell therapy offers disease modifying potential and therefore whether it can limit, prevent or possibly reverse progression of arthritis.
Interventions
This study will look to prospectively assess the response of symptomatic joint arthritis to mesenchymal stem cell therapy using the following protocol :
- Intra-articular injection of up to 50million stem cells at 0 and 6 months.
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. A small abdominal liposuction will be performed by an appropriately qualified medical cl
This study will look to prospectively assess the response of symptomatic joint arthritis to mesenchymal stem cell therapy using the following protocol : - Intra-articular injection of up to 50million stem cells at 0 and 6 months. 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. A 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 suitably 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-articular (joint) injections will be performed by a suitably qualified procedural clinician with an medical degree equivalent of Bachelor of Medicine & Bachelor of Surgery (MBBS). These injections will be performed under radiological guidance. Dose of mesenchymal stem cells will be dependent on the size of joint treated (ie. Knee - 50Millions MSCs, hip/ankle/shoulder - 20Millions MSCs, small joints of the hand - 10Million MSCs) Only one joint/region will be treated at any given time. The repeat injection at 6months 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
Melbourne Stem Cell Centre
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
Inclusion Criteria : 1. Radiological diagnosis of arthritis using the American College of Rheumatology criteria (Altman, 1986). 2. Primary arthritis treatment already undertaken defined as: analgesia/anti-inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella, 2000), weight loss and nutritional management as prescribed by a dietician or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures as the first line of treatment in osteoarthritis (Thompson, Gordon et al. 2009). 3. Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.
Exclusion criteria
Exclusion Criteria: 1. Age <18yrs. 2. Pregnancy (accepted contra-indication as no safety data on this population). 3. Breastfeeding (accepted contra-indication as no safety data on this population). 4. Have other causes of their symptoms suspected to be due to serious pathology such as tumour or referral from the spine. These conditions are not under investigation within the current project. 5. Current cancer. 6. History of significant organ impairment/failure (ie. renal failure). 7. History of allergy to any substances used within the treatments. 8. Bovine allergy
Outcome results
None listed