SCUlpTOR Study

The SCUlpTOR trial is a research study aiming to see if stem cells injected into the knees of people with knee osteoarthritis can improve their symptoms compared with placebo. The medical opinion about stem cell therapy for treating osteoarthritis is mixed due to limited research evidence and considerable costs.

The SCUlpTOR is a two year study investigating whether stem cell injections into the knee can improve symptoms and slow disease progression in people with mild to moderate knee osteoarthritis.

The stem cells we use originally came from a healthy donor/master cell bank and are made following standard manufacturing process to make sure they are safe and standardised.

The SCUlpTOR study is a randomised, placebo-controlled trial meaning that participants will be randomly assigned to either treatment; that is, half will receive placebo injections and the other half will receive stem cell injections.

Recruitment for the SCUlpTOR Study has now closed.

Study aims

Aim 1

To observe whether stem cell injections into the knee of people with osteoarthritis improves symptoms

Aim 2

To observe whether stem cell injections into the knee of people with osteoarthritis slows disease progression

Who can take part?

The study is suitable for people who:

• Are aged 40 years or older and living in Australia (and have a Medicare number).

• Have knee OA and moderate pain assessed by the visual analogue pain intensity scale from 0 (no pain) to 100 (worst pain possible).

• Have internet access and an active email account.

• Are willing to stop or maintain the same knee OA treatments (e.g. supplements, physiotherapy) for the duration of the study.

• Are willing to stop or minimise the use of anti-inflammatory drugs (e.g. Aspirin, Nurofen, Ibuprofen, Mobic, Voltaren, etc.) and other analgesics (e.g. opioids), except for paracetamol (only for rescue pain relief) for the duration of the study. This includes stopping all pain medications for one week before each study assessment.

• Are able to speak and read English sufficiently to understand study procedures, complete questionnaires and provide informed consent.

• Are willing and able to travel for the study visits. • Study visits will occur at Castlereagh Imaging in St Leonards and Cremorne for those participants based in NSW and at Qscan Radiology in North Hobart and Menzies Institute for those based in Tasmania.

What is involved for participants?

• If you are interested in participating in this trial, you will be asked to fill out an online screening survey to see if the study is suitable for you.

• If you meet the survey eligibility criteria, you will need to have two knee X-rays taken from different angles using a referral that the study team will send to you.

• If your X-ray scans meet the eligibility criteria, you will need to have a MRI taken of your study knee using a referral sent by the study team.

• Once in the study, you will get three knee injections, which will be given when you join the study (baseline), week-3, and at 12-months.

• You will be asked to attend seven study visits, and we will check on you regularly over 24 months. Your blood and urine will be taken at your baseline visit, at your 6-month visit and at your 24-month visit.

• For the duration of the study, we will monitor your use of pain medication by asking you to complete fortnightly online surveys. Every month, the online form will include questions about your healthcare usage and any symptoms or problems you have had (adverse events).

• To keep up to date with your knee symptoms, you will be asked to fill out follow-up pain questions in addition to your fortnightly surveys at 3, 6, 12 and 24-months after your first injection. For the pain surveys we require a 7-day medication washout, without any pain medication before the pain assessments.

SCUlpTOR Study FAQs

  • Stem Cells as a symptom- and strUcture-modifying Treatment for tibiofemoral OsteoaRthritis

  • You will remain in the study for 24-months after your first injection.

  • Screening:

    Complete the screening form

    if you are eligible, sign the consent form

    we will send you an x-ray referral

    x-ray visit (visit #1)

    if you are eligible after the x-ray, we will send you the baseline surveys

    Baseline:

    Once the baseline surveys are completed we’ll send you an MRI referral

    MRI appointment (visit #2)

    after you’ve had the MRI, if everything is fine, we will book your first injection visit (visit # 3)

    you will then be in the study for 24 months from that date

    Week 3:

    The second injection (visit #4) is 3 weeks after the first injection date

    6-months:

    (visit # 5) This visit will be after 6 months, for blood and urine tests only, NO INJECTION

    12-months:

    The third injection visit (visit #6) is at 12 months, no blood or urine tests required on this visit

    24-months:

    The final visits for MRI and final blood & urine tests are at 24 months.

    After this visit (visit # 7), you find out your group allocation.

  • The study has started in 2021 and is ongoing, we recruit participants on a daily basis and will stop recruitment when we reach the required number (440 participants).

  • The stem cells we use originally came from a healthy donor/master cell bank and are made following standard manufacturing process to make sure they are safe and standardised.

  • No. This is a randomised, placebo-controlled trial meaning that participants will be randomly assigned by a computer to either the placebo or stem cell treatment.

  • As soon as you have completed the online screening and signed the consent form (if eligible) we can send you for an x-ray.

  • There is a 50/50 chance of receiving the placebo treatment or receiving the stem cell treatment.

  • You will receive three injections over a 24-month period. Your first injection will be at your baseline study visit after the screening procedures (X-ray and MRI), your second injection will 3 weeks after baseline and your third injection will be at 12 months after baseline.

  • No. Participants will be required to have their X-ray taken at Castlereagh Imaging in St Leonards if based in NSW or QScan Imaging, Hobart City if base in TAS. This is to ensure that knee positions in all X-rays are the same.

  • We can have a look at your most recent X-ray to pre-determine your eligibility but if you are considered potentially eligible you will be required to have an X-ray taken at Castlereagh Imaging in St Leonards for those based in NSW or at QScan in North Hobart for those based in TAS. The requirements of the X-ray are specific to the study to ensure that all participants are assessed in the same way. The above X-ray locations have been briefed with the requirements of the study.

  • All visits must be at the designated imaging centres as they have the required settings of images for the study and the approval to see our participants according to the standardised protocol, including for the x-ray and the MRI visits.

  • If you are eligible for the study, there will be a total of seven (7) in person visits:

    • X-ray scan

    • MRI scan

    • Baseline (first) injection

    • Week 3 injection

    • 6-month blood collection

    • 12-month injection

    • 24-month MRI scan

  • Blood and urine samples are collected at the baseline (first) visit, 6-month visit and 24-month visit. This is for health monitoring purposes while you remain in the study. Our study doctor will review any abnormal results and contact you accordingly. Blood and urine samples are also kept in a biobank and used for future studies or clinical trials investigating osteoarthritis, if you agree to it.

  • A MRI is taken during the screening process and, if you are admitted into the study, at month-24. The MRI scans are important to compare joint structures before and after the study. For this reason, if you have a MRI contraindication such as a pacemaker or cochlear implants, you will not be able to join the study.

  • You will not be paid but we will provide you with a $20 gift card at visits 3, 4 and 5 (baseline, week-3 and 6-month), $40 at visit 6 (12-month) and $70 at visit 7 (24-month). The total amount ($170) is to compensate for your transport expenses, your time and inconvenience for data collection.

  • The study involves 7 face-to-face visits for 24 months and there is a 50% chance of receiving a placebo injection, we cannot guarantee any results regardless of your group allocation. Since this is a big commitment and will have a big cost for you if you're interstate, our study team decided that we’re only recruiting people from NSW and Tasmania, to avoid disappointment and participant dropouts.

  • If you are interested in joining the study, you will need to complete the online pre-screening survey here. If you meet the eligibility criteria, the study team will be in contact via email or phone.

  • If you are not going away for more than 6 months we can probably work around your trip dates and schedule the initial visits when you are around. If you are planning to travel for more than 6 months during the first year of the study, unfortunately, this could be an issue for our timelines. While you are away, you need to commit to completing the fortnightly surveys sent via email.

  • You are allowed to take pain medication and anti-inflammatories when required, we only request that you try to minimise their use, if possible. You’ll only need to stop the pain medication for 7 days every 3 months before the pain assessments, and we will let you know via email when the time comes.

    Some examples of pain medication are:

    • Paracetamol (Panadol, Panadol Osteo, Panamax)

    • Ibuprofen (Nurofen, Advil, Rafen, Nuromol)

    • Diclofenac (Voltaren, Voltaren gel, Inflamax)

    • Meloxican (Mobic)

    • Opioids (Tramadol, Oxycodone, Codeine, Endone, Fentanyl, Methadone)

    • Neuropathic pain drugs (Lyrica, Cymbalta)

  • Yes, you can still take your supplements like, glucosamine, chondroitin, fish oil, vitamins, turmeric, etc. We only request that you maintain the same supplement routine for 24 months while in the study, so we can attribute any changes in symptoms to the treatment you received from the study.

  • No, you don’t need to stop your exercises, maintaining a regular exercise routine is a helpful strategy to manage osteoarthritis. We only request that you try to maintain the same exercise routine from the time you start the study for the 24 months while you are participating. This is so we can attribute any changes in symptoms to the treatment you received from the study.

Benefits of joining a clinical trial

Access to new and potentially effective treatments

By participating in a clinical trial, you may gain access to innovative treatments that are not yet available to the general public. These treatments may be more effective or have fewer side effects than current treatments and can potentially improve their symptoms and quality of life.

Opportunity to help others and advance to medical knowledge

By joining a clinical trial, participants are helping to advance scientific knowledge about osteoarthritis and its treatment. Their participation may lead to new treatments and a better understanding of the condition, which can benefit future generations.

Increased awareness and understanding of osteoarthritis

Clinical trial participants may have access to additional resources, such as educational materials and support groups. Clinical trials can also provide a supportive environment where participants can connect with others who are dealing with similar health issues.