Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized controlled trial comparing clinical outcomes of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee to conservative treatment

This research study, called IMPACT, is testing a new treatment for people with damage to the cartilage in their knee. This is often where bones rub together, causing pain and stiffness. The study wants to see if this new treatment, which involves transplanting healthy cartilage cells along with a special product for healing, works better than the standard care people usually receive. We will be closely watching participants for 9 months to see if their knee pain improves, if they can move more easily, and if their overall quality of life gets better. We'll be using special questionnaires to track these changes. We'll also use MRI scans to look at how well the knee joint is healing at different times after treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

27 Nov 2024

Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea)

What is this study about?

This study is investigating a new way to treat common knee issues where the smooth, protective cartilage on the ends of your bones wears away or gets damaged. This damage can cause pain, stiffness, and make it hard to do everyday activities. The new treatment, called IMPACT, involves taking healthy cartilage cells from your own body, growing them, and then putting them back into your knee alongside a special product designed to help them grow and heal the damaged area. The idea is to repair the knee surface, making it smoother and reducing pain.

We're comparing this new IMPACT treatment to what's called 'conservative treatment' – this usually means things like pain relief medicines, physical therapy, or injections, depending on what your doctor recommends. By comparing these two approaches, we want to find out if the IMPACT treatment is more effective in reducing pain, improving how your knee works, and making your overall life better.

To see how well the treatments work, we'll be asking people to complete questionnaires about their pain, daily activities, and general quality of life at 3, 6, and 9 months after treatment. We'll also use special MRI scans at 6 and 18 months to take detailed pictures of the inside of the knee. These scans will help us see if the cartilage is healing and regenerating, giving us a clearer picture of the long-term effects of the treatment.

Key takeaways

This study is testing a new knee cartilage treatment called IMPACT.
It compares IMPACT to standard (conservative) treatment for knee pain.
The study tracks pain, knee function, and quality of life for 9 months.
MRI scans will check cartilage healing at 6 and 18 months.
Adults with symptomatic cartilage damage in specific knee areas can participate.
Participation involves questionnaires and MRI scans over 18 months.

Who may be eligible?

This study is open to adults aged 18 years and older. There's no upper age limit, meaning older adults can also take part. We're involving both men and women in the study.

To be eligible, you must have pain in your knee due to damaged cartilage. This damage needs to be in specific parts of the knee joint: either on the ends of your thigh bone (femoral condyles) or in the groove where your kneecap moves (trochlea).

Essentially, if you're an adult experiencing symptoms because of cartilage damage in one of these areas of your knee, you might be able to join. Your doctor would help determine if your specific condition fits the study's requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have pain in your knee caused by damaged cartilage?
Has a doctor told you the cartilage damage is on your thigh bone (femoral condyles) or kneecap groove (trochlea)?
Are you able to attend follow-up appointments and scans over 18 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the new IMPACT treatment or standard conservative treatment for your knee cartilage damage. You won't get to choose which one you receive; it will be decided randomly, like flipping a coin. You will have several visits to the clinic over a period of 18 months. During these visits, medical staff will check your knee, and you'll fill out questionnaires about your pain, how well your knee is working, and your general well-being.

These questionnaires will be completed at 3, 6, and 9 months after your treatment. You will also have MRI scans of your knee at 6 and 18 months to let the doctors see how your cartilage is healing. The total duration of your participation, from beginning to the final scan, will be around 18 months. You will be closely monitored throughout this time.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and innovative treatment for your knee cartilage damage or receiving careful monitoring of your condition. However, as with any medical procedure or treatment, there are potential risks. If you receive the IMPACT treatment, there are risks associated with any surgical procedure, such as infection, pain, or problems with healing. If you receive conservative treatment, your condition may not improve, or it could even worsen. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is cartilage damage in the knee?

Cartilage is the smooth, slippery tissue that covers the ends of bones in your knee, allowing them to glide easily. Damage means this tissue is worn or torn, which can cause pain, swelling, and stiffness.

What is IMPACT treatment?

IMPACT is a new treatment where healthy cartilage cells from your own body are taken, grown, and then put back into your knee with a special product to help repair the damaged areas.

What does 'conservative treatment' mean?

Conservative treatment usually refers to non-surgical options like pain relievers, physical therapy, or injections to manage your knee pain and improve function.

Will I know which treatment I'm getting?

You will be told whether you are receiving the IMPACT treatment or conservative treatment. The choice between the two will be made randomly, like drawing lots.

How long will I be in the study?

If you join, you will be part of the study for about 18 months, with follow-up appointments and scans to monitor your progress.