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

Verified siteRegistered drugNo placebo

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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 that have the potential to help repair and regenerate damaged tissues. These stem cells are prepared in a suspension and injected directly into the knee joint. The study will compare the effects of this stem cell treatment to a placebo injection to understand its safety and how well it works in reducing knee symptoms.

Participants in the study will receive either the stem cell treatment or a placebo through an intra-articular injection, which means the injection is given directly into the knee joint. The study will monitor participants over a period of time to observe any changes in knee pain and function. The main goal is to assess improvements in knee symptoms, such as pain and movement, using a tool called the Knee Injury and Osteoarthritis Score (KOOS). Additionally, the study will track any side effects or adverse events that may occur during the first year after treatment.

Throughout the study, participants will also undergo various assessments, including MRI scans to evaluate cartilage regeneration and other tests to measure knee swelling and muscle strength. The study aims to provide valuable insights into the potential benefits of using stem cells for treating knee osteoarthritis and to explore how this treatment works in the body. The findings from this research could lead to new and effective therapies for individuals suffering from this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination to ensure the presence of knee osteoarthritis.
Eligibility criteria include being aged 40 to less than 75 years, experiencing chronic knee pain for at least 6 months, and having Grade II-III osteoarthritis.
Step 2
Baseline measurements
Baseline measurements are taken to assess knee symptoms. This includes the Knee Injury and Osteoarthritis Score (KOOS) and a pain diary for the first 30 days.
Additional assessments may include MRI scans to evaluate cartilage condition and other physical tests to measure knee function and swelling.
Step 3
Treatment administration
The treatment involves an intra-articular injection into the knee joint. This may be either the active treatment with allogeneic adipose tissue-derived mesenchymal stem cells or a placebo.
The injection is administered as a suspension for injection in a pre-filled syringe.
Step 4
Post-treatment monitoring
After the injection, monitoring occurs to track any adverse events and changes in knee symptoms. This monitoring continues for the first year after treatment.
Patients are required to maintain a pain diary for the first 30 days post-treatment to document any changes in pain levels.
Step 5
Follow-up assessments
Follow-up assessments are conducted to evaluate the long-term effects of the treatment. These assessments include repeated KOOS evaluations and MRI scans to monitor cartilage regeneration.
Additional physical tests may be performed to assess range of motion, swelling, and muscle condition around the knee.

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 **osteoarthritis** (a type of joint disease) according to the Kellgren Lawrence Classification, 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** (a type of knee alignment issue).
Must have **osteoarthritis** in the medial, lateral, or both compartments of the knee.
Must have a **BMI** (Body Mass Index) of less than 35.
Must be able to speak Danish.
Must be legally competent and able to sign a written consent form.

Who cannot join the trial?

10 criteria

Patients with any other joint disease besides knee osteoarthritis cannot participate. Osteoarthritis is a condition where the protective cartilage in the knee wears down over time.
Individuals who have had a knee surgery in the past 6 months are excluded.
People with a history of allergic reactions to similar treatments are not eligible.
Participants who are currently taking part in another clinical trial are not allowed.
Women who are pregnant or breastfeeding cannot join the study.
Anyone with a serious illness that could affect the study results is excluded.
Individuals with a history of drug or alcohol abuse in the past year are not eligible.
Patients with an infection in the knee area are excluded.
People with a history of cancer in the last 5 years, except for certain skin cancers, cannot participate.
Individuals with a condition that affects the immune system, like HIV, are not eligible.

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Aarhus University
Aarhus, Denmark

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Investigated drugs

Allogenic Mesenchymal Stem Cells are special cells derived from fat tissue that have the ability to develop into different types of cells. In this trial, they are injected directly into the knee joint to see if they can help reduce symptoms of knee osteoarthritis, such as pain and stiffness. The goal is to determine if these cells can improve knee function and provide relief from osteoarthritis symptoms.

What is already known about the treatment

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 use in treating knee osteoarthritis. The main therapeutic indication is to alleviate symptoms associated with knee osteoarthritis. At the molecular level, mesenchymal stem cells are believed to work by reducing inflammation and promoting the repair of damaged tissues in the joint. They are classified as a type of regenerative medicine, focusing on the body's ability to heal itself.

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. 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 gradual, often worsening over several years.