AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Feasibility and Safety Assessment of a Combined Advanced Therapy Medicinal Product Based on A Polymeric Medical Device Combined to Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Hydrogel Mixture for The Treatment of Knee Femoral Cartilage Isolated Lesions

This early-stage study is looking at a new way to treat specific types of knee cartilage damage. If you have an isolated patch of worn knee cartilage, this trial might be relevant. The treatment uses a special gel mixed with your own bone marrow cells, combined with a medical device. Researchers want to see if this new approach is safe and can be given to people effectively. This is the very first time this treatment is being tried in humans, which means it's about understanding how it works and if it has any immediate side effects, rather than how well it cures the condition. It's an important step in developing potential future treatments.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Lamina Therapeutics

Enrolment target

Start

09 Oct 2024

Patients with knee femoral cartilage isolated lesions

What is this study about?

This research study is focused on a new way to treat damage to the smooth, slippery cartilage that covers the ends of your bones in the knee joint. This cartilage helps your knee move smoothly, and when it gets damaged, it can cause pain and stiffness. The study is specifically looking at what are called 'isolated lesions' – this means there's a single, distinct area of cartilage damage, not widespread arthritis.

The experimental treatment involves taking some of your own cells from your bone marrow. These specific cells, called mesenchymal stem cells, are thought to have properties that could help repair damaged tissues. These cells are then mixed into a special gel and used alongside a medical device to treat the damaged area in your knee. The idea is to create a scaffold and environment that encourages the body's natural healing processes.

This is a very early study, known as 'Phase I' research. This means it's the first time this particular treatment is being given to humans. The main goals are to check if the treatment is safe for people to receive and if it's possible to carry out the procedure effectively. It's not designed yet to see how well it fixes the cartilage in the long term, but rather to understand how the body reacts to it and to identify any immediate concerns. This foundational work is crucial for developing new and better treatments for knee cartilage problems in the future.

Key takeaways

It's an early-stage study (Phase I) checking safety, not a cure.
The treatment uses your own bone marrow cells and a medical device.
It's for specific, isolated cartilage damage in the knee.
Participation involves surgery and regular follow-up appointments.
Risks and benefits should be discussed thoroughly with the study team.

Who may be eligible?

This study is looking for adults aged 18 and over who have a specific type of knee cartilage damage. To be considered, you must have what doctors call an 'isolated lesion' on the cartilage in your thigh bone (femur) within the knee joint. This means you have a single, distinct area of damage, rather than general wear and tear across the whole knee.

Both men and women can take part in this research. The most important thing is that your particular knee problem matches exactly what the researchers are looking for. Doctors involved in the trial will check your medical history and perform tests to see if you fit all the necessary requirements.

As this is a very early trial, there will likely be other strict rules about your general health or other medical conditions you might have. These rules are put in place to ensure the safety of everyone taking part and to make sure the results are as clear as possible.

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 a specific, single area of cartilage damage in your knee?
Is the damage located on the thigh bone (femur) in your knee?
Are you able to commit to several hospital visits and procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of checks to make sure you are suitable. This would involve medical examinations, tests, and discussions with the study team. If you are eligible, you would undergo a procedure to collect bone marrow, typically from your hip bone. Your cells would then be prepared.

You would then have surgery on your knee where the special gel mixed with your cells and the medical device would be applied to the damaged cartilage. After the procedure, you would have regular follow-up visits to the clinic or hospital. These visits would involve check-ups, physical examinations, and possibly scans or other tests to monitor your knee and your general health, and to see how your body is reacting to the new treatment. The total duration of your involvement could extend for several months, with various appointments occurring over that time.

Potential risks and benefits

Participating in this early-stage study means you could be among the first to receive a new treatment for knee cartilage damage, which might lead to a future therapy for you and others. However, as this is a new treatment, the full benefits are not yet known, and there's no guarantee it will improve your condition. There are potential risks associated with any medical procedure, including the bone marrow collection and knee surgery, such as pain, infection, or other complications. The study team will carefully explain all known risks. Remember, you have the right to withdraw from the study at any time and 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.

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Unverified
France

Common questions

What is cartilage and why is it important?

Cartilage is the smooth, rubbery tissue that covers the ends of bones in your joints, like the knee. It helps your bones glide past each other easily and acts as a shock absorber. When it gets damaged, it can cause pain and make movement difficult.

What does 'isolated lesion' mean?

An 'isolated lesion' means there's a single, distinct area of damage or wear on the cartilage, rather than widespread damage all over the knee joint, which would be more like general arthritis.

What is a 'Phase I' trial?

A Phase I trial is the very first stage of testing a new treatment in humans. It primarily focuses on checking if the treatment is safe, if it causes any serious side effects, and how the body handles it. It's not mainly to see if it cures the condition.

Are the cells used in the treatment from my own body?

Yes, the study uses your own cells, specifically from your bone marrow. This is often preferred because it reduces the risk of your body rejecting the cells.

Will this treatment definitely fix my knee pain?

This early study is mainly about safety and feasibility, not curing the condition. While researchers hope the treatment will eventually be helpful, there's no guarantee it will improve your specific knee pain in this initial trial.