RecruitingPHASE1INTERVENTIONAL

FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis

This study is exploring a new cell therapy called aeGF as a potential treatment for knee osteoarthritis. aeGF is made from cells found in human gum tissue. Early research in animals suggests it might help reduce inflammation, ease pain, and even regrow cartilage in the knee. This is the very first time this treatment is being tested in humans. The main goal of this 'Phase 1' study is to see if a single injection of aeGF into the knee joint is safe for people with osteoarthritis. Fifteen participants will receive the injection and be carefully monitored for a year to check for any side effects and understand how their bodies react to the treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Scarcell Therapeutics S.A.S.

Enrolment target

Start

14 Aug 2025

Estimated completion

01 Feb 2028

Osteoarthritis, Knee

What is this study about?

This study is looking into a new way to treat knee osteoarthritis, a common condition where the protective cartilage in your knee joint wears down. A company has developed a special cell therapy called aeGF, which stands for "allogeneic engineered Gingival Fibroblasts." Don't worry about the long name – essentially, it's a treatment made from special cells taken from the gum tissue of a human donor. These cells are then prepared in a laboratory.

Now, why gum tissue? Well, early studies in animals have suggested that these specific cells might be able to reduce swelling (inflammation), help with pain, and even encourage the repair of cartilage. The goal of this study is to see if these promising effects also apply to people. It's important to remember that this is the first time aeGF is being used in humans, so the main focus is on making sure it's safe.

The researchers want to find out if a single injection of aeGF directly into the knee joint is safe for people living with knee osteoarthritis. If it proves to be safe, it could open the door for more research into whether it can effectively treat the symptoms and potentially slow down or reverse the damage of osteoarthritis in the future.

Key takeaways

This is a 'first-in-human' study testing a new cell therapy for knee osteoarthritis.
The treatment, aeGF, is made from human gum tissue cells.
The primary goal is to assess the safety of a single injection into the knee.
Early animal studies suggested potential benefits like pain relief and cartilage repair.
The study lasts one year after the injection, with several follow-up appointments.
Participation helps advance medical knowledge about new osteoarthritis treatments.

Who may be eligible?

To be considered for this study, you need to be at least 40 years old. You must have knee osteoarthritis that causes pain and shows certain changes on an X-ray. Specifically, your X-rays should show changes of moderate osteoarthritis, not very mild or very severe. Your knee pain should also be at a certain level.

There are also reasons why you might not be able to join. For instance, if your knee osteoarthritis is caused by another specific health problem (like rheumatoid arthritis or a past serious injury) rather than typical wear and tear, you wouldn't be eligible. Also, if you've recently had other knee treatments like steroid injections, or if you're taking certain medications like strong anti-inflammatory drugs, you might not be able to participate. They'll also check if you've had knee surgery on the study knee in the past or if major knee surgery is planned soon.

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 at least 40 years old?
Do you have knee osteoarthritis causing pain and visible on X-rays?
Is your osteoarthritis considered moderate (not very mild or very severe)?
Have you avoided certain knee treatments or medications recently?
Have you not had knee surgery on the affected knee recently?
Are you able and willing to attend all study appointments over one year?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for one year after you receive the injection. First, you'll have a screening appointment to make sure you're a good fit. If you're eligible, you'll come back for the treatment. This will involve a single injection of the study drug, aeGF, directly into your knee, guided by ultrasound to make sure it goes to the right place.

After the injection, you'll get a phone call within about a week to check in and see how you're feeling and if you've had any side effects. You'll then have follow-up visits at the hospital at 1 month, 3 months, 6 months, 12 months, and 24 months after your injection. These visits are to monitor your health and how you're reacting to the treatment.

Potential risks and benefits

As this is a very early study, the main benefit for participants is contributing to medical research and helping doctors understand if this new treatment is safe. While animal studies showed promising results like pain relief and cartilage repair, we don't know if these benefits will apply to humans, or if they will happen in this specific study. Potential risks include discomfort or other issues from the injection itself, or unexpected side effects from the new treatment. Because the treatment is new, all potential risks may not be fully known upfront. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Oxford University Hospitals NHS Foundation Trust (Nuffield Orthopaedic Centre, Oxford)
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is aeGF?

aeGF is a new cell therapy made from special cells found in human gum tissue, which is being tested as a treatment for knee osteoarthritis.

What is the main goal of this study?

The main goal is to find out if a single injection of aeGF into the knee is safe for people with knee osteoarthritis. This is the first time it's being used in humans.

How long will I be in the study if I take part?

If you join, the study will last for one year after you receive the injection, with several follow-up appointments during that time.

Will I definitely get better if I join?

It's not guaranteed that you will feel better. This is a safety study, which means the main purpose is to check for side effects and how your body reacts to the new treatment, not necessarily to cure your condition.

What happens at a follow-up visit?

Follow-up visits involve checking on your general health, looking for any side effects, and monitoring your knee condition after the injection.

How to find out more

Sarah Sorrel (CEO)

sarah.sorrel@scarcell.com +33611729481 Official trial record

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