None listed
Conditions
Brief summary
SCUlpTOR is a 24-month research study sponsored by the University of Sydney, evaluating the efficacy and cost-effectiveness of stem cell injections compared with placebo in people with knee OA. Currently, the medical opinion about stem cell therapy for treating osteoarthritis remains highly controversial, given the considerable cost of treatment and very limited scientific evidence of efficacy and safety. Therefore, we aim to conduct this trial to ascertain whether or not intra-articular stem cell injections improve symptoms and slow disease progression in people with mild to moderate knee OA. The stem cells being used were originally sourced from a healthy donor/master cell bank following a standard manufacturing process and release tests to optimise safety and batch to batch reproducibility.
Interventions
- The dose administered: 2.5 x 10^7 cell culture-expanded mesenchymoangioblast-derived mesenchymal stem cells (MSCs) suspended in 5 ml excipient solution.
- The frequency and duration of administration: three knee intra-articular injections of allogeneic MSCs performed at baseline, week 3 and 52 (12-months).
- The mode of administration: ultrasound-guided intra-articular injections applied to the study knee delivered by an experienced radiologist.
- Strategies used to monitor adherence to the in
- The dose administered: 2.5 x 10^7 cell culture-expanded mesenchymoangioblast-derived mesenchymal stem cells (MSCs) suspended in 5 ml excipient solution. - The frequency and duration of administration: three knee intra-articular injections of allogeneic MSCs performed at baseline, week 3 and 52 (12-months). - The mode of administration: ultrasound-guided intra-articular injections applied to the study knee delivered by an experienced radiologist. - Strategies used to monitor adherence to the intervention: the number of injections delivered will be recorded in the participants' notes on REDCap - Study visit form.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Ability and willingness to participate and complete the study • Having internet access and an active email account • Having functional English • Australian Citizen or Permanent resident • People >=40 years of age • Knee OA as defined by the clinical and radiographic American College of Rheumatology (ACR) criteria • Presence of pain in the study knee for at least half of the days in the previous month • Average pain intensity >= 40 and <= 90 on a 0-100 visual analogue scale (VAS) over the past week before the Online Screening and Baseline surveys • Kellgren-Lawrence grade (KLG) 2 or 3 of the study knee based on knee radiographs • Medial or lateral minimal joint space width (mJSW) between 0.5 and 4 mm of the study knee based on radiographs • Willingness to undergo a new knee X-ray and MRI • Willingness to stop or maintain a routine (on the same dosage and frequency) of conservative treatments • Willingness to stop or minimise the use of anti-inflammatory drugs and other analgesics (except paracetamol for rescue pain relief) for the duration of the study • Willingness to undergo a 1-week medication wash-out (for all pain medications) before each pain assessment (baseline, 3, 6, 9, 12, 15, 18, 21 and 24-months). • Willingness to avoid a new treatment for knee OA during the study • Willingness and ability to travel for study visits according to their site
Exclusion criteria
• Incomplete online screening surveys • Participants that are non-responders after completing the screening survey but before being enrolled • Women who are pregnant or breastfeeding, or women of childbearing potential not willing to use contraceptive methods for the duration of the study • Bilateral symptomatic knee OA if the patient-reported pain intensity in the contralateral knee is >= 30 on a 0-100 VAS • Significant injury in the study knee that led to substantial loss of function or surgeries within the past 6 months • Prior knee joint replacement or high tibial osteotomy in the study knee • Surgery on the study knee within the past 12 months • Planned surgery for the study knee in the next 24 months • History of crystalline arthropathy, autoimmune arthritis, hemochromatosis or fibromyalgia. Except for the following conditions: i. participants diagnosed with gout are eligible for the study as long as the condition is being appropriately treated and they have not experienced flare-ups for at least 12 months ii. participants diagnosed with hemochromatosis but with normal iron levels for at least 12 months are eligible for the study • Signs of acute knee joint inflammation (i.e., red, swollen and hot) and/or abnormal synovial fluid suggestive of either crystal or infection; • Any painful muscular or neurological condition of the lower limb that, in the opinion of the investigators, is the main contributor to the pain and/or loss of function in the study knee which may interfere with the self-reported assessment • Immunosuppression or acute infective processes • Cancer or other tumour-like lesions, except for non-melanoma skin cancer which has been removed and not active within the past 3 years • Hyaluronic acid (HA) injection within the past 6 months • Autologous blood product or stem cell injection in the study knee within the past 12 months • Steroid injections in any joint within the past 6 months • Regularly taking centrally acting analgesics (e.g., opioid analgesics, duloxetine and pregabalin) • Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrolment • Any unstable concurrent clinically significant acute, chronic medical conditions or abnormal laboratory findings that, in the judgment of the Investigator, would jeopardise the safety of the participant, interfere with study objectives or affect the participant’s compliance • Needle phobia • Contraindications to MRI • Inability to fit into the MRI knee coil
Outcome results
None listed