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Study Comparing Allogeneic and Autologous Mesenchymal Stem Cells with Hyaluronic Acid 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 treatments for knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The study will compare three different treatments: allogenic mesenchymal stem cells (code name: Allo_MSC), autologous mesenchymal stem cells (code name: Aut_MSC), and an active control treatment with hyaluronic acid. Mesenchymal stem cells are special cells that can develop into different types of cells and are used to help repair damaged tissues. In this study, the stem cells are prepared as a solution for injection directly into the knee joint.

The purpose of the study is to compare how effective these treatments are in improving the symptoms of knee osteoarthritis. Participants will receive one of the treatments and will be monitored over time to see how their symptoms change. The study will look at various aspects such as pain levels, knee function, and any changes in the knee joint as seen on imaging tests like MRI. The study will also assess the quality of life of participants and any side effects related to the treatments.

Participants will be randomly assigned to receive one of the treatments, and the study will be conducted over a period of time to observe the effects. The treatments will be given through injections into the knee, and participants will have regular follow-up visits to monitor their progress. The study aims to provide valuable information on which treatment might be most beneficial for people with knee osteoarthritis.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written informed consent is required to participate.

    Eligibility criteria include having knee osteoarthritis with specific characteristics, such as Kellgren and Lawrence grade 2, 3, or 4 gonarthrosis, and a body mass index between 20 and 35 kg/m².

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's knee condition and overall health. This includes haemacytometric and biochemical analyses to ensure there are no significant health issues that would contraindicate treatment.

  3. Step 3

    Randomization and treatment allocation

    The patient will be randomly assigned to one of three treatment groups: allogenic mesenchymal stem cells, autologous mesenchymal stem cells, or hyaluronic acid as an active control.

    All treatments are administered via intraarticular injection, which means the solution is injected directly into the knee joint.

  4. Step 4

    Treatment administration

    The patient will receive the assigned treatment as a solution for injection. The frequency and duration of administration will be determined by the study protocol.

  5. Step 5

    Follow-up assessments

    Follow-up assessments will be conducted to monitor the patient's response to treatment. These assessments will include measurements of pain intensity, functional capacity, and symptomatology using various scales such as the VAS pain scale, Lequesne scale, and WOMAC scale.

    Imaging studies, such as T2-mapping MR images, will be used to estimate lesion improvement or stabilization.

  6. Step 6

    Quality of life evaluation

    The patient's perceived quality of life will be assessed using the SF-12 scale at 6, 12, and 24 months.

  7. Step 7

    Biological and genomic studies

    Exploratory biological studies will be conducted to evaluate the immune system in the patient's blood and serum on days +7 and +30.

    Genomic studies will be performed on the advanced therapy drugs manufactured in the study to explore correlations with clinical and biological parameters.

  8. Step 8

    Completion of the study

    The study is estimated to end by May 31, 2026. Final assessments will be conducted to evaluate the overall efficacy and safety of the treatments.

Who can join the trial?

10 criteria

  • The patient must have **knee osteoarthritis**, which is a condition that affects the knee joint.
  • The patient should have **Kellgren and Lawrence grade 2, 3, or 4 gonarthrosis**, which refers to the severity of the knee condition as seen on an X-ray.
  • The patient must have a **chronic painful knee with mechanical features**, meaning the knee pain is long-lasting and related to movement.
  • There should be an **absence of local or systemic septic process**, meaning there should be no infection in the knee or elsewhere in the body.
  • **Haemacytometric and biochemical analyses** should not show significant changes that would prevent treatment. This means blood tests and other lab tests should be normal.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after understanding what it involves.
  • The patient should be able to **understand the nature of the study**, meaning they can comprehend what the study is about and what it requires.
  • The patient should have a **Body Mass Index (BMI) between 20 and 35 kg/m²**, which is a measure of body fat based on height and weight.
  • The study is open to both **male and female** participants.
  • The study is for adults, typically those in the age range of **18 to 65 years**.

Who cannot join the trial?

10 criteria

  • Patients who have had a knee replacement surgery.
  • Patients with severe knee deformities.
  • Patients with active infections in the knee area.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of cancer in the last 5 years.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients taking medications that suppress the immune system.
  • Patients with blood clotting disorders, which affect how the blood clots.
  • Patients with severe heart, liver, or kidney diseases.
  • Patients who have participated in another clinical trial in the last 30 days.
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Investigated drugs

  • Allogeneic Mesenchymal Stem Cells (MSC)

    are stem cells derived from a donor. In this trial, they are used to treat patients with knee osteoarthritis. These cells have the potential to reduce inflammation and promote healing in the knee joint, which may improve pain and function.

  • Autologous Mesenchymal Stem Cells (MSC)

    are stem cells taken from the patient's own body. They are used in this trial to treat knee osteoarthritis by potentially reducing inflammation and aiding in the repair of damaged tissues in the knee, which could lead to improved joint function and reduced pain.

  • Hyaluronic Acid

    is a substance that is naturally found in the body, particularly in the joints. In this trial, it is used as an active control treatment for knee osteoarthritis. It is believed to help lubricate the joint, reduce pain, and improve mobility.

What is already known about the treatment

Hyaluronic Acid – This medication is administered through injection directly into the knee joint. It is currently used in medical practice for the treatment of knee osteoarthritis, and its effectiveness is well-documented in medical literature. The main therapeutic indication is to relieve pain and improve joint function in patients with knee osteoarthritis. Hyaluronic acid works by acting as a lubricant and shock absorber in the joint, helping to improve mobility and reduce pain. It is classified as a viscosupplementation agent.

Investigated diseases

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease that affects the cartilage in the knee. Over time, the cartilage wears down, leading to pain, swelling, and reduced movement in the joint. As the condition progresses, the bones may start to rub against each other, causing further pain and stiffness. This can lead to the formation of bone spurs and a decrease in the joint space. The disease often develops slowly and can affect one or both knees. It is more common in older adults and can be influenced by factors such as weight, genetics, and previous joint injuries.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514545-11-00Protocol codeARTROCELLEstimated enrolment120 patientsSponsorFundacion De Investigacion Biomedica De Salamanca

sourced from the EU Clinical Trials Register and site verification

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