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Study on the Effects of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Patients with Knee Osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 involves the use of allogeneic adipose tissue-derived mesenchymal stem cells, which are special cells taken from fat tissue and used to help repair and regenerate damaged tissues. These stem cells are prepared as a suspension for injection and are given directly into the knee joint.

The purpose of the study is to assess the safety and effectiveness of this stem cell treatment compared to a placebo. Participants in the study will receive an injection into their knee joint, either with the stem cell treatment or a placebo. The study will monitor knee symptoms and any side effects over a period of time to determine how well the treatment works and how safe it is for patients.

Throughout the study, participants will be asked to keep a diary of their knee pain and other symptoms. They will also undergo various assessments, including the Knee Injury and Osteoarthritis Score (KOOS) and MRI scans, to evaluate changes in their knee condition. The study aims to provide valuable insights into the potential benefits of using stem cells for treating knee osteoarthritis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, chronic knee pain, and osteoarthritis grade.
Participants must be legally competent and able to provide written consent.
Step 2
Initial assessment
An initial assessment is conducted to evaluate knee symptoms using the Knee Injury and Osteoarthritis Score (KOOS).
Additional evaluations include pain levels, range of motion, and knee swelling.
Step 3
Treatment administration
Participants receive an intra-articular injection in the knee. This involves injecting a suspension containing allogeneic adipose tissue-derived mesenchymal stem cells.
The injection is administered using a pre-filled syringe.
Step 4
Placebo administration
Some participants may receive a placebo injection, which contains sodium chloride solution.
The placebo is also administered intra-articularly.
Step 5
Monitoring and follow-up
Participants are monitored for knee symptoms and any adverse events for up to one year after treatment.
A pain diary is maintained for the first 30 days post-treatment to track pain levels.
Step 6
Secondary assessments
Secondary assessments include evaluating cartilage regeneration using MRI and measuring knee swelling and muscle bulk.
Pain is also assessed using the Numeric Rating Scale (NRS).
Step 7
Study completion
The study is estimated to conclude by October 2027.
Final assessments are conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

8 criteria

Must be a male or female aged between 40 and less than 75 years old.
Must have had chronic knee pain for at least 6 months, with a pain level of 4 or higher on a scale when the pain is at its worst.
Must have Grade II-III knee osteoarthritis, which is a way to describe the severity of the condition, with a joint space width of 1-3 mm.
Must have an x-ray of the hip, knee, and ankle showing no more than 5 degrees of valgus/varus deformity, which means the knee is not significantly bent inward or outward.
Must have osteoarthritis in the medial (inner), lateral (outer), or both compartments of the knee.
Must have a Body Mass Index (BMI) of less than 35. BMI is a measure of body fat based on height and weight.
Must speak Danish.
Must be legally competent, meaning able to make legal decisions, and able to sign a written consent form.

Who cannot join the trial?

12 criteria

Patients who have had a knee replacement surgery.
Patients with severe knee deformities.
Patients with active infections in the knee area.
Patients with a history of cancer in the last 5 years.
Patients who are pregnant or breastfeeding.
Patients with autoimmune diseases, which are conditions where the body's immune system attacks its own tissues.
Patients taking medications that suppress the immune system, which are drugs that reduce the body's ability to fight infections.
Patients with uncontrolled diabetes, which means their blood sugar levels are not well managed.
Patients with severe heart disease, which affects the heart's ability to pump blood effectively.
Patients with liver or kidney failure, which means these organs are not working properly.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to any component of the study treatment.

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Aarhus University
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Aarhus, Denmark

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Investigated drugs

Allogenic Mesenchymal Stem Cells are special cells that are taken from the fat tissue of a donor. These cells have the ability to develop into different types of cells and are used in this trial to see if they can help reduce symptoms of knee osteoarthritis when injected directly into the knee joint. The goal is to assess if these cells can improve knee function and reduce pain.

What is already known about the treatment

Allogenic Mesenchymal Stem Cells – This medication is administered through an injection directly into the knee joint. It is currently being explored in clinical trials for its potential to treat knee osteoarthritis. The main therapeutic indication is to alleviate symptoms associated with knee osteoarthritis. At the molecular level, these stem cells are believed to promote tissue repair and reduce inflammation by differentiating into various cell types and releasing bioactive molecules. They are classified under regenerative medicine therapies.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease that affects the cartilage in the knee. Over time, the cartilage that cushions the knee joint wears down, leading to pain, stiffness, and swelling. As the condition progresses, the joint may become less flexible, and bone spurs can develop around the joint. This can result in increased discomfort and difficulty in performing everyday activities such as walking or climbing stairs. The severity of symptoms can vary, with some individuals experiencing mild discomfort while others may have significant pain and mobility issues. The progression of knee osteoarthritis can be influenced by factors such as age, weight, and previous joint injuries.