#1 Clinical Trials Search in Europe

Emiplacel

Emiplacel, also known as PLX-PAD, is an innovative cell therapy being studied for the treatment of mild to moderate knee osteoarthritis. This article explores the ongoing clinical trial investigating the safety and effectiveness of Emiplacel injections in patients suffering from this common joint condition. We’ll discuss the trial’s objectives, eligibility criteria, and potential benefits for those living with knee osteoarthritis.

Table of Contents

What is EMIPLACEL?

EMIPLACEL, also known by its product code PLX-PAD, is an innovative medical treatment being developed for patients with mild to moderate knee osteoarthritis[1]. It is classified as an Advanced Therapy Medicinal Product (ATMP), which means it’s a cutting-edge treatment using biological materials[1].

Specifically, EMIPLACEL is a cell therapy product. It consists of placental adherent stromal cells, which are special cells derived from the placenta[1]. These cells are prepared as a dispersion for injection, meaning they are suspended in a liquid that can be injected into the patient’s knee[1].

How Does EMIPLACEL Work?

EMIPLACEL is designed to be injected directly into the knee joint space and the surrounding muscles. The goal of this treatment is to:

  • Reduce inflammation in the knee joint
  • Improve the structure of the cartilage
  • Alleviate symptoms such as pain and limited function
  • Enhance overall quality of life for patients with knee osteoarthritis

The placental cells in EMIPLACEL are believed to have immunomodulatory properties, which means they can help regulate the immune system’s response in the joint, potentially reducing harmful inflammation[1].

Target Condition: Knee Osteoarthritis

Knee osteoarthritis is a common condition where the cartilage in the knee joint gradually wears away, causing pain, stiffness, and reduced mobility. It typically affects older adults and can significantly impact quality of life[1].

Clinical Trial Details

EMIPLACEL is currently being studied in a Phase I/IIa clinical trial. This means it’s in the early stages of testing in humans to evaluate its safety and get initial data on its effectiveness[1]. Key details of the trial include:

  • It’s a prospective study, meaning it will follow patients forward in time
  • It’s double-blinded and randomized, which helps ensure the results are reliable
  • The main goal is to assess the safety and tolerability of EMIPLACEL injections
  • The trial will also look at potential improvements in pain and knee function

Potential Benefits of EMIPLACEL

If successful, EMIPLACEL could offer several benefits for patients with knee osteoarthritis:

  1. Pain reduction: The primary measure of effectiveness will be changes in pain scores[1].
  2. Improved knee function: The trial will assess overall knee function using standardized measures[1].
  3. Better quality of life: Researchers will evaluate how the treatment affects patients’ overall well-being[1].
  4. Potential to slow disease progression: The study will look at changes in joint structure using advanced imaging techniques[1].

Eligibility Criteria

The trial has specific criteria for who can participate. Some key requirements include:

  • Age: Participants must be between 50 and 80 years old
  • Diagnosis: Mild to moderate knee osteoarthritis, confirmed by X-ray
  • Pain level: Specific pain scores in the affected knee
  • Failed previous treatments: Participants should have tried other treatments without success

There are also several factors that would exclude someone from participating, such as recent knee surgery or certain other medical conditions[1].

Safety and Monitoring

Patient safety is a top priority in this trial. Researchers will carefully monitor for any side effects, with special attention to:

  • Allergic reactions
  • Local reactions at the injection site
  • Joint reactions
  • Signs of immunosuppression (weakening of the immune system)

Participants will be closely followed for up to 156 weeks (3 years) to assess long-term safety and effectiveness[1].

Future Implications

If EMIPLACEL proves to be safe and effective, it could represent a significant advance in the treatment of knee osteoarthritis. This cell therapy approach might offer a new option for patients who haven’t found relief with current treatments.

The trial will also collect data on genetic factors and biomarkers, which could help researchers better understand osteoarthritis and potentially lead to more personalized treatments in the future[1].

Aspect Details
Drug Name Emiplacel (PLX-PAD)
Condition Studied Mild to moderate knee osteoarthritis
Trial Phase Phase I/IIa
Main Objective Assess safety and tolerability of Emiplacel injections
Primary Efficacy Endpoint Change in WOMAC pain score at week 26 compared to baseline
Key Assessments MRI scans, WOMAC score, KOOS score, PROMIS-29, pain medication use, genetic profiling, biomarker analysis
Treatment Administration Local injections into knee joint space and surrounding muscle
Follow-up Duration Up to 156 weeks (3 years)

FAQ

  • What is Emiplacel (PLX-PAD)? Emiplacel, also known as PLX-PAD, is a cell therapy made from placental adherent stromal cells. It's being studied as a potential treatment for mild to moderate knee osteoarthritis.
  • How is Emiplacel administered in the clinical trial? In the trial, Emiplacel is administered through local injections into the space inside the knee joint and the surrounding muscle.
  • What are the main goals of the Emiplacel clinical trial? The main goals are to assess the safety and tolerability of Emiplacel injections and to evaluate their potential to improve knee pain and function in patients with osteoarthritis.
  • Who is eligible to participate in the Emiplacel clinical trial? The trial is open to adults aged 50 to 80 with mild to moderate knee osteoarthritis who have had knee pain for at least 3 months and have not responded well to conservative treatments.
  • How long does the Emiplacel clinical trial last? The trial includes follow-up assessments up to 156 weeks (3 years) after treatment, with key evaluations at 26 weeks, 52 weeks, and 156 weeks.

Ongoing Clinical Trials on Emiplacel

  • Study on the Safety and Effectiveness of PLX-PAD Cells for Patients with Mild to Moderate Knee Osteoarthritis

    Not yet recruiting

    1 1
    Investigated drugs:
    Germany

Glossary

  • Osteoarthritis (OA): A common joint disorder characterized by the breakdown of joint cartilage and underlying bone, often affecting the knees.
  • PLX-PAD: The sponsor's product code for Emiplacel, which is the cell therapy being studied in this clinical trial.
  • WOMAC score: Western Ontario and McMaster Universities Osteoarthritis Index, a standardized questionnaire used to evaluate pain, stiffness, and physical function in patients with knee osteoarthritis.
  • KOOS score: Knee Injury and Osteoarthritis Outcome Score, an assessment tool used to measure knee-related symptoms and function.
  • MRI: Magnetic Resonance Imaging, a medical imaging technique used to visualize internal structures of the body, including knee joint tissues.
  • Synovitis: Inflammation of the synovial membrane, which lines the inside of joints.
  • ATMP: Advanced Therapy Medicinal Product, a class of innovative therapies including cell therapies like Emiplacel.
  • Biomarker: A measurable indicator of a biological state or condition, used to assess disease progression or treatment effects.
  • NPRS: Numeric Pain Rating Scale, a tool used to measure pain intensity on a scale from 0 to 10.
  • PROMIS-29: Patient-Reported Outcomes Measurement Information System, a set of person-centered measures that evaluate physical, mental, and social health.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-plx-pad-cells-for-patients-with-mild-to-moderate-knee-osteoarthritis/