RecruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint

This research study is investigating a new way to treat cartilage damage in the knee. It uses special cells, called mesenchymal stem cells, that come from umbilical cord tissue. The main goal is to find out if this treatment is safe and if it helps to repair damaged knee cartilage. It's open to adults aged 18 to 60 who have specific types of cartilage damage and are considering surgery. If you join, you would have an operation where the treatment is applied to your knee, followed by regular check-ups over two years. This helps doctors monitor your progress and make sure the treatment is safe and working well.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BIONCaRT GmbH

Enrolment target

Start

10 Nov 2025

Estimated completion

01 Nov 2028

Cartilage Damage

What is this study about?

You might be reading this because you or someone you know has knee pain from damaged cartilage. Cartilage is the smooth, rubbery tissue that covers the ends of bones in your joints and helps them glide easily. When it gets damaged, it can cause pain, swelling, and make it hard to move.

This study is looking into a new treatment for cartilage damage in the knee. It uses something called 'mesenchymal stem cells' (don't worry about the scientific name!). These are special cells that come from umbilical cord tissue, which is usually discarded after a baby is born. Researchers believe these cells might help the body repair damaged cartilage. The study aims to see if this treatment is safe for people and if it actually helps improve their knee cartilage.

This is a 'Phase 1/2' study, which means it's still in the earlier stages. Doctors are very carefully checking to make sure the treatment doesn't cause harm and are also starting to gather information on whether it works to heal the knee. Your participation could help doctors learn more about potential new ways to treat knee cartilage damage in the future.

Key takeaways

This study is exploring a new treatment for knee cartilage damage using cells from umbilical cords.
It's a Phase 1/2 study, meaning doctors are checking safety and early effectiveness.
Participation involves knee surgery to apply the treatment, followed by two years of follow-up visits.
It's for adults aged 18-60 with specific types of knee cartilage damage.
You'll be carefully screened to ensure you meet the study requirements.

Who may be eligible?

This study is looking for adults aged between 18 and 60 years old who have knee cartilage damage that doctors think needs surgery. You would need to have certain types of cartilage damage, specifically on specific parts of your knee like the thigh bone or kneecap, and the damaged area needs to be a certain size.

There are also some things that would mean you couldn't join. For example, if your knee arthritis is too severe, or if you have certain other health conditions like an autoimmune disease, cancer in the last five years, or specific problems with your knee stability or other structures. You also can't have had certain injections in your knee recently, or had major joint replacements in your other knee or hip within the last year.

Your general health, weight (BMI), and specific pain scores for your knee would also be checked to make sure you're a good fit for the study. If you're interested, the study team would go through all these details with you carefully to see if you meet the 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 between 18 and 60 years old?
Do you have cartilage damage in your knee that your doctor thinks needs surgery?
Is your knee arthritis not too severe (Kellgren-Lawrence grade less than III)?
Do you not have other serious health conditions like autoimmune disease or cancer within the last five years?
Have you not had certain injections in your knee or major joint replacements recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to have a thorough check-up to make sure you meet all the requirements. This includes physical exams and checks of your medical history. Once you’re approved, you would have an operation on your knee. During this surgery, the new treatment will be carefully applied to the damaged cartilage in your knee. Following the surgery, you would have regular follow-up visits with the study doctors over a period of two years. These visits are very important. They allow the doctors to closely monitor how your knee is healing, check for any changes or side effects from the treatment, and gather information on how well the treatment is working. The total study duration, from your initial checks to your final follow-up, would be around two years.

Potential risks and benefits

Like any new medical treatment or surgery, there are potential benefits and risks to consider. The main potential benefit is that this new treatment might help your damaged knee cartilage to heal, reducing pain and improving movement. However, because this is an early-stage study, we don't yet know for sure how effective it will be. Potential risks are similar to those of any knee surgery, such as infection, pain, or problems with healing. There's also the unknown risk of using a new treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie
Verified postcode
Altenburg, Germany· Recruiting
St. Nikolaus Stifts-Hospital
Verified postcode
Andernach, Germany· Recruiting
Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie
Verified postcode
Bamberg, Germany· Recruiting
Evangelisches Waldkrankenhaus Spandau
Verified postcode
Berlin, Germany· Recruiting
GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken
Verified postcode
Dinslaken, Germany· Recruiting
UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
Verified postcode
Dresden, Germany· Recruiting
Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie
Verified postcode
Greven, Germany· Recruiting

Common questions

What are 'umbilical cord cells'?

These are special cells collected from umbilical cord tissue, which is usually thrown away after a baby is born. Scientists believe they have properties that might help repair damaged body tissues, like cartilage.

Will I know if I'm getting the treatment or a dummy treatment?

In this specific study, all eligible patients will receive the investigational product during their knee surgery. There is no 'dummy' or 'placebo' treatment being used.

How long will the study doctors follow me?

You'll be followed by the study doctors for about two years after your surgery to monitor your progress and safety.

Will I need to stay in hospital?

The study involves knee surgery, so you will likely need a short hospital stay, followed by recovery time at home, similar to other knee operations.

Can I stop being part of the study once I've started?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Kristina Thamm, PhD

kristina.thamm@bioncart.com +491607697453 Official trial record

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