Study on the Safety of Allocetra for Patients with Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for knee osteoarthritis, a common condition that causes pain and stiffness in the knee joint. The treatment being tested is called Allocetra-OTS, which is a solution for injection made from special cells known as allogeneic peripheral blood mononuclear cells. These cells are prepared in a way that makes them enter an early stage of cell death, known as apoptosis, which is thought to help reduce inflammation and pain in the knee.

The purpose of the study is to evaluate the safety and tolerability of Allocetra-OTS when injected directly into the knee joint. The study will compare the effects of this treatment to a placebo, which is a substance with no active ingredients. Participants will receive injections in their knee and will be monitored over several months to see how their knee pain and function change over time. The study will also look at any side effects that may occur during the treatment period.

Participants in the study will be randomly assigned to receive either the Allocetra-OTS treatment or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, with follow-up visits to assess the participants’ progress and any changes in their knee condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 45 and 80 years, chronic knee osteoarthritis, and specific pain levels.

Radiographic evidence of knee osteoarthritis is required, assessed by X-ray, with a Kellgren-Lawrence Grade 2 or 3 in the affected knee.

2 screening period

During the screening period, daily pain in the knee is measured over 7 days. Pain levels must be at least 5 out of 10 on a numerical rating scale, with no single score exceeding 9.

A washout period of at least 48 hours is required if using certain pain medications. Acetaminophen or metamizole may be used for pain during this time.

3 treatment phase

The treatment involves an intra-articular injection of either Allocetra-OTS or a placebo into the knee joint. The specific dose and regimen are determined during the safety run-in phase.

The primary goal is to assess the safety and tolerability of the treatment compared to the placebo.

4 follow-up assessments

Follow-up assessments occur at 3, 6, and 12 months after the last treatment. These include evaluations of knee pain, stiffness, and disability using the WOMAC score.

Quality of life is measured using the Euro Quality of Life-5-dimension questionnaire at 6 and 12 months.

5 monitoring adverse events

Throughout the study, any adverse events or serious adverse events are monitored and recorded. This monitoring continues from the start of the study up to 6 months after the last injection.

Who Can Join the Study?

Age between 45 and 80 years.
Have chronic osteoarthritis in the knee, which means long-term joint pain in the knee. At the screening visit, the patient should report knee pain of at least 4 out of 10 when not using medication.
Have radiographic evidence of knee osteoarthritis, which means an X-ray shows signs of the condition, specifically Kellgren-Lawrence Grade 2 or 3 in the knee.
Experience daily knee pain with at least 4 measurements showing a pain score of at least 5 out of 10, but no single score higher than 9, over a 7-day period during screening. This is after stopping pain medication for at least 48 hours, or longer if using long-acting pain relief. Acetaminophen or metamizole (a type of pain relief) can be used during this time.
Have knee pain that has not improved after at least 3 months of standard treatment.
Be willing to avoid other treatments injected into the knee and follow the study’s rules about other medications and therapies.
Women who can have children and all men must agree to use 2 forms of birth control: one barrier method (like a condom or diaphragm) and one hormonal method (like birth control pills or a patch) before joining the study and for 4 weeks after receiving the study treatment. Those who are unlikely to conceive (like those who are surgically sterile, postmenopausal, or not sexually active with the opposite sex) do not need to follow this rule.
Be able to understand and willing to sign a consent form, which means agreeing to follow the study’s rules and restrictions.
At the investigator’s discretion, be able to follow all study procedures, be available for the entire study, and be willing to come back for follow-up visits.

Who Cannot Join the Study?

Patients who have a different condition than knee osteoarthritis cannot participate. Knee osteoarthritis is a condition where the knee joint becomes worn down over time.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study organizers.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have limited ability to protect their own interests.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Sanos A/S	Gandrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Allogeneic Peripheral Blood Mononuclear Cells Induced To An Early Apoptotic State

Allocetra is a medication being studied for its potential to treat knee osteoarthritis. It is administered directly into the knee joint through an injection. The trial aims to determine the safety and tolerability of Allocetra, as well as to find the most effective dose and regimen for patients.

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, swelling, and stiffness, making movement difficult. Over time, the cartilage wears away, causing bones to rub against each other, which can result in increased pain and decreased mobility. The progression of knee osteoarthritis can vary, with some individuals experiencing a slow worsening of symptoms, while others may notice a more rapid decline. Factors such as age, weight, and previous joint injuries can influence the development and progression of the disease. Regular physical activity and maintaining a healthy weight can help manage symptoms and slow progression.

Trial ID:

2023-508748-23-00

Protocol code:

ENX-CL-05-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety of Allocetra for Patients with Knee Osteoarthritis

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