Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis

This research study is investigating a new treatment called Allocetra for people suffering from knee osteoarthritis. We want to understand how safe this treatment is and if it causes any side effects. Researchers will also be looking closely to see if Allocetra can help reduce knee pain and improve how well people can move around and do their daily activities. Participants will receive either Allocetra or a dummy treatment (placebo) to see if there's a real difference. The study will track participants for up to a year, focusing on their comfort and general well-being after treatment.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Enlivex Therapeutics Ltd.

Enrolment target

156

Start

21 Mar 2024

Knee osteoarthritis

What is this study about?

This study is designed to explore a new potential treatment called Allocetra for people who have knee osteoarthritis. Osteoarthritis is a common condition that causes pain, stiffness, and swelling in the joints, making everyday tasks difficult. The main purpose of this early-stage research is to understand how safe Allocetra is when injected into the knee and if it causes any unwanted side effects. Researchers will be carefully monitoring participants to make sure the treatment is well-tolerated.

Beyond safety, the study also aims to see if Allocetra can help ease the pain in the knee and improve how well people can use their knee. This means looking at whether participants feel less pain, can move more easily, and have an overall better quality of life. Half of the participants will receive Allocetra, and the other half will receive a harmless saltwater injection (a placebo) that looks exactly the same, so no one knows who is getting which. This helps researchers accurately compare the effects of the new treatment.

By following participants for several months after their last injection, the study hopes to gather important information. This will help doctors understand if Allocetra could be a helpful future treatment option for knee osteoarthritis. The information collected from this study is crucial for deciding whether to move forward with larger research studies.

Key takeaways

This study is for people with knee osteoarthritis.
It's testing a new treatment called Allocetra.
The main goals are to check safety and see if it helps with pain.
Participants will receive either Allocetra or a dummy treatment.
The study involves regular clinic visits and lasts up to a year.
You can stop participating at any time.

Who may be eligible?

This study is open to both men and women who are aged 18 years and older. There is no upper age limit, meaning older adults can also take part.

To be considered for the study, you would need to have been diagnosed with knee osteoarthritis. The medical team will check other specific health details to make sure the study is a safe and suitable fit for you.

Before you join, a doctor will review your medical history and current health to ensure you meet all the necessary requirements for taking part.

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 diagnosis of knee osteoarthritis?
Are you able to attend regular clinic appointments?
Are you comfortable potentially receiving a placebo?
Are you generally willing to follow study procedures for up to a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive injections directly into your knee joint. Some participants will receive the investigational treatment, Allocetra-OTS, while others will receive a matching placebo, which is an inactive substance. Neither you nor the study doctors will know which one you are receiving.

Throughout the study, you will have regular visits to the clinic for check-ups and assessments. These visits will involve answering questions about your pain levels and how well you can move, as well as filling out questionnaires about your quality of life. The study will monitor your health and any changes for up to 6 months after your last injection, with some checks extending to 12 months for your general well-being and pain levels. The total duration of your participation, including follow-up, will vary, but you should expect to be involved for up to one year.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as receiving a new treatment that might help your condition, as well as close medical attention from a dedicated team. However, there are also potential risks, including possible side effects from the investigational treatment or the injection procedure itself. It's important to remember that the new treatment might not work or could have unknown effects. Your safety and well-being are paramount, and you have the right 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.

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Unverified
Denmark

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common condition where the cartilage in your knee joint wears down over time, causing pain, stiffness, and difficulty moving.

What is Allocetra?

Allocetra is a new treatment being studied for knee osteoarthritis. This trial will help us learn more about its safety and whether it helps with pain.

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

No, neither you nor your doctor will know if you are receiving the active treatment or a placebo. This helps ensure the study results are fair and unbiased.

How long will I be in the study?

You'll be involved in the study for up to a year, including regular visits and follow-up checks after your last injection.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, and it will not affect your future medical care.