RecruitingPHASE2INTERVENTIONAL

Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

This study is investigating a new treatment for a specific type of knee arthritis called patellofemoral osteoarthritis, where the cushioning cartilage behind your kneecap gets damaged. It's a common condition causing pain and difficulty. We are testing a new method called N-TEC, which uses cartilage grown from cells taken from your own nose. This is being compared to a more common treatment that involves injections of Platelet-Rich Plasma (PRP), which uses a concentrated part of your own blood. The main aim is to see if the N-TEC treatment is more effective at reducing pain and improving knee function over two years, and to understand how it helps damaged cartilage regenerate. We're also checking for any side effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

Start

06 Jun 2024

Estimated completion

01 Sep 2029

Patellofemoral Osteoarthritis

What is this study about?

Many people worldwide suffer from knee pain and stiffness, and often this pain comes from a condition called patellofemoral osteoarthritis. This is when the smooth, cushioning cartilage on the back of your kneecap and the groove it slides in becomes worn away. It can cause significant pain and make everyday activities difficult. This study is dedicated to finding better ways to help people with this specific type of knee problem.

We are looking at a new treatment called N-TEC. This involves taking a tiny piece of tissue from your nose, growing new cartilage from these cells in a lab, and then carefully placing this new cartilage into the damaged area of your knee. We believe these engineered cells can help your knee repair itself. To see how well it works, we’re comparing N-TEC with another treatment that involves injections of Platelet-Rich Plasma (PRP). PRP uses a concentrated solution from your own blood, which contains growth factors that can help with healing.

The main goal of this study, which is in its second phase, is to see if N-TEC can significantly reduce pain and improve how well your knee works compared to PRP injections. We will carefully measure your pain levels and knee function over two years. We'll also use scans like X-rays and MRI to see if the new cartilage is growing and repairing the damaged areas, which could mean it's actually changing the course of the disease rather than just managing symptoms. We'll also keep a close eye on your overall health and any side effects during the whole study.

Key takeaways

This study compares a new cartilage repair method with a standard injection.
It targets knee pain from worn cartilage behind the kneecap.
You'll be followed for two years to check pain, knee function, and healing.
You might get either a cartilage implant grown from nose cells or PRP injections.
There are specific requirements for age and existing knee conditions to join.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old. You should have ongoing pain in the front of your knee due to patellofemoral osteoarthritis, and your knee pain must be significant enough to impact your daily life, as shown by questionnaire scores. It's important that other standard non-surgical treatments (apart from PRP injections) haven't worked for you.

There are also some specific conditions about your knee: the cartilage damage needs to be of a certain type and severity, and your knee should have a good range of motion. We'll also check your overall health through blood tests. You'll need to be willing to fully participate in the study, including attending all follow-up appointments and completing rehabilitation after any procedure.

You wouldn't be able to join if you've had knee surgery on the affected knee in the last year (unless it was just minor diagnostic surgery), or if you have severe overall knee arthritis (not just behind the kneecap). Other reasons might include being unable to have an MRI scan, having significant issues with the knee meniscus (another shock absorber in the knee), severe knee alignment problems, or if you've had a kneecap dislocation recently. A high body mass index (BMI) over 35 would also exclude you from this study.

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 between 18 and 65 years old?
Have you tried other knee pain treatments (besides PRP) that haven't worked?
Is your knee pain mainly behind your kneecap?
Do you have good movement in your knee (can you straighten and bend it well)?
Have you *not* had knee surgery on the affected knee in the last 12 months (excluding minor diagnostic keyhole surgery)?
Is your body mass index (BMI) 35 or lower?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening process to ensure you meet all the study requirements. Once confirmed, you would be randomly assigned to either receive the N-TEC treatment or the Platelet-Rich Plasma (PRP) injections. If you receive N-TEC, it involves a minor procedure to take a small sample from your nose, followed by a separate procedure to implant the engineered cartilage into your knee. PRP treatment involves injections into your knee.

Throughout the study, you'll have several follow-up visits at 6, 12, and 24 months. At these visits, you'll complete questionnaires about your pain and knee function, and you'll have scans like X-rays and MRI to monitor the healing of your knee. We will also carefully record any side effects you experience. You will also need to follow a rehabilitation plan after your treatment. The total duration of your active participation in the study, including all follow-ups, will be 24 months.

Potential risks and benefits

Participating in this study might offer the potential benefit of improved pain relief and better knee function from a new treatment that could help repair damaged cartilage, rather than just managing symptoms. However, as with any medical procedure, there are potential risks, including those associated with surgery if you receive the N-TEC treatment (such as infection, bleeding, or pain at the surgical site), or discomfort from injections if you receive PRP. There might also be a risk that the treatment doesn't work as well as hoped, or you might experience side effects. It's important to remember that joining the study is entirely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (9)

Poliklinika Ivković
Verified postcode
Zagreb, Croatia· Recruiting
Poliklinika Ortho Plus
Verified postcode
Zagreb, Croatia· Recruiting
Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Not yet recruiting
Orthopädische Klinik König-Ludwig-Haus
Verified postcode
Würzburg, Germany· Not yet recruiting
University Hospital Basel
Verified postcode
Basel, Switzerland· Recruiting
Crossklinik
Verified postcode
Basel, Switzerland· Recruiting
Hôpitaux universitaires de Genève
Verified postcode
Geneva, Switzerland· Recruiting
Ospedale Regionale di Lugano
Verified postcode
Lugano, Switzerland· Recruiting
Sportclinic, Klinik Hirslanden
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is patellofemoral osteoarthritis?

It's a type of arthritis affecting the cartilage specifically behind your kneecap, causing pain and stiffness, especially when bending your knee.

What is N-TEC?

N-TEC is a new treatment where cartilage cells from your own nose are grown in a lab and then used to repair damaged cartilage in your knee.

What is PRP?

PRP stands for Platelet-Rich Plasma. It's a treatment using a concentrated part of your own blood, full of healing factors, which is injected into the injured area.

How long will the study last if I join?

The study will involve follow-up visits and assessments over two years (24 months) after your treatment.

Will I know which treatment I'm getting?

You will be randomly assigned to either the N-TEC group or the PRP group, but you will know which treatment you are receiving.

How to find out more

Marcus Mumme, Dr

marcus.mumme@usb.ch 0041615565885 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.