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Allogeneic Adult Human Mesenchymal Stem Cells Ex-Vivo Expanded

This article explores the use of Allogeneic Adult Human Mesenchymal Stem Cells Ex-Vivo Expanded in clinical trials for treating knee osteoarthritis. The study compares this innovative treatment with autologous mesenchymal stem cells and hyaluronic acid, aiming to evaluate its efficacy, safety, and potential to improve patients’ quality of life. We’ll delve into the trial’s objectives, eligibility criteria, and expected outcomes, providing valuable insights for those interested in advanced therapies for knee osteoarthritis.

Table of Contents

What are Mesenchymal Stem Cells (MSCs)?

Mesenchymal stem cells (MSCs) are a type of adult stem cell that can develop into various cell types, including bone, cartilage, and fat cells. In this study, researchers are using MSCs that have been grown and expanded in a laboratory setting, specifically referred to as “ALLOGENEIC ADULT HUMAN MESENCHYMAL STEM CELLS EX-VIVO EXPANDED”.[1]

These cells are called “allogeneic” because they come from a donor, not the patient receiving the treatment. They are obtained from adult bone marrow and then grown (expanded) outside the body (ex-vivo) to increase their numbers before being used as a treatment.

Treatment for Knee Osteoarthritis

This advanced therapy is being studied as a potential treatment for knee osteoarthritis, a condition where the cartilage in the knee joint breaks down, causing pain, stiffness, and reduced mobility.[1]

Clinical Trial Overview

A Phase III clinical trial is being conducted to compare the effectiveness of allogeneic MSCs against two other treatments for knee osteoarthritis:[1]

  1. Autologous MSCs (stem cells from the patient’s own body)
  2. Hyaluronic acid (a substance already used in osteoarthritis treatment)

This is a multicenter, randomized, open-label study, which means it’s being conducted at multiple hospitals or clinics, patients are randomly assigned to treatment groups, and both patients and doctors know which treatment is being given.

Eligibility Criteria

To participate in this study, patients must meet certain criteria, including:[1]

  • Having knee osteoarthritis of grade 2, 3, or 4 on the Kellgren and Lawrence scale (a method for classifying the severity of knee osteoarthritis)
  • Experiencing chronic knee pain with mechanical features
  • Being between 18 and 75 years old
  • Having a Body Mass Index (BMI) between 20 and 35 kg/m²

Patients cannot participate if they have certain conditions or circumstances, such as:

  • Pregnancy or breastfeeding
  • A current cancer diagnosis
  • Recent knee injections (within the last 3 months)
  • Allergy to gentamicin (an antibiotic used in the cell culture process)

Treatment Arms

The study compares three different treatments:[1]

  1. Allogeneic MSCs: 40 million cells in a 4 ml injection into the knee joint
  2. Autologous MSCs: 40 million cells in a 4 ml injection into the knee joint
  3. Hyaluronic Acid: 60 mg in a 3 ml injection into the knee joint

Study Objectives

The main goal of this study is to compare how well allogeneic MSCs work compared to autologous MSCs and hyaluronic acid in treating knee osteoarthritis. Researchers will look at clinical, functional, and radiological responses.[1]

Additional objectives include:

  • Analyzing changes in patients’ quality of life
  • Assessing the feasibility of using these cell treatments across multiple treatment centers
  • Monitoring side effects and safety
  • Studying the characteristics of the cell products and their effects on the immune system

Outcome Measures

To determine how well the treatments work, researchers will measure:[1]

  • Pain intensity using the VAS pain scale
  • Functional capacity and pain using the Lequesne scale
  • Symptoms and physical disability using the WOMAC scale
  • Improvements in knee joint condition using MRI scans
  • Quality of life using the SF-12 scale

Potential Benefits and Considerations

Mesenchymal stem cell therapy shows promise for treating knee osteoarthritis by potentially regenerating damaged cartilage and reducing inflammation. However, it’s important to note that this is still an experimental treatment being studied in a clinical trial.[1]

Patients considering participation should discuss the potential risks and benefits with their healthcare provider and the study team. It’s also important to understand that participation in a clinical trial involves regular follow-up visits and assessments over an extended period (in this case, up to 24 months).

Aspect Details
Study Type Phase III, multicenter, randomized, open-label clinical trial
Condition Knee osteoarthritis
Interventions 1. Allogeneic mesenchymal stem cells (40 million/4 ml)
2. Autologous mesenchymal stem cells (40 million/4 ml)
3. Hyaluronic acid (60mg/3ml)
Primary Outcomes Pain intensity, functional capacity, symptomatology, and lesion improvement/stabilization
Secondary Outcomes Quality of life, product compliance, adverse effects, genomic studies, immune system changes
Key Inclusion Criteria Adults 18-75 years, knee osteoarthritis (Kellgren and Lawrence grade 2-4), BMI 20-35 kg/m²
Key Exclusion Criteria Pregnancy, neoplastic disease, recent intra-articular infiltrations, participation in other clinical trials
Follow-up Period 24 months

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to compare the effectiveness of allogeneic mesenchymal stem cells (MSC) and autologous MSC against hyaluronic acid in treating knee osteoarthritis. The study aims to evaluate clinical, functional, and radiological responses in patients.
  • Who is eligible to participate in this trial? Eligible participants include adults aged 18-75 with knee osteoarthritis (Kellgren and Lawrence grade 2, 3, or 4), chronic knee pain, and a Body Mass Index between 20 and 35 kg/m2. Participants must not have any significant health issues that could interfere with the treatment or evaluation.
  • How are the stem cells administered in this trial? The stem cells are administered through an intra-articular injection. For both allogeneic and autologous mesenchymal stem cell treatments, patients receive 40 million cells in a 4 ml solution injected directly into the knee joint.
  • What are the primary outcomes being measured in this study? The primary outcomes include pain intensity (measured by the VAS pain scale), functional capacity (assessed by the Lequesne scale), symptomatology and perceived physical disability (evaluated using the WOMAC scale), and improvement or stabilization of knee lesions (observed through T2-mapping MR images). These outcomes are primarily measured at 12 months after treatment.
  • Are there any risks associated with participating in this trial? While specific risks are not detailed in the provided information, the trial does monitor for adverse effects and other pharmacovigilance parameters in all three treatment arms. Participants with allergies to gentamicin (an antibiotic used in the cell culture process) are excluded from the study to minimize potential risks.

Ongoing Clinical Trials on Allogeneic Adult Human Mesenchymal Stem Cells Ex-Vivo Expanded

  • Study Comparing Allogeneic and Autologous Mesenchymal Stem Cells with Hyaluronic Acid for Patients with Knee Osteoarthritis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Allogeneic: Cells or tissues that are obtained from a genetically different donor of the same species. In this context, it refers to mesenchymal stem cells derived from a donor other than the patient receiving the treatment.
  • Mesenchymal Stem Cells (MSCs): A type of adult stem cell that can develop into various cell types, including bone, cartilage, muscle, and fat cells. They have potential therapeutic applications due to their ability to repair and regenerate tissues.
  • Osteoarthritis: A degenerative joint disease characterized by the breakdown of joint cartilage and underlying bone, often causing pain and stiffness. In this study, it specifically refers to knee osteoarthritis.
  • Intra-articular injection: A procedure where medication is injected directly into a joint space, in this case, the knee joint.
  • Hyaluronic Acid: A naturally occurring substance in joint fluid that acts as a lubricant and shock absorber. It is used as a treatment for osteoarthritis and serves as an active control in this study.
  • VAS pain scale: Visual Analog Scale for pain, a measurement instrument used to assess the intensity of pain experienced by a patient.
  • Lequesne scale: A functional assessment tool used to evaluate the severity of osteoarthritis and its impact on daily activities.
  • WOMAC scale: Western Ontario and McMaster Universities Osteoarthritis Index, a widely used set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee and hip.
  • T2-mapping MR: A magnetic resonance imaging technique used to assess the quality of cartilage in joints, providing detailed information about tissue composition and structure.
  • Kellgren and Lawrence grade: A system used to classify the severity of knee osteoarthritis using five grades (0-4), based on the formation of osteophytes, bone sclerosis, and joint space narrowing.

References

  1. http://clinicaltrials.eu/trial/study-comparing-allogeneic-and-autologous-mesenchymal-stem-cells-with-hyaluronic-acid-for-patients-with-knee-osteoarthritis/