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Autologous Microfat

This article explores an innovative clinical trial investigating the use of Autologous Microfat combined with Platelet-Rich Plasma (PRP) injections as a treatment for radiocarpal osteoarthritis. The study aims to compare this new approach with the established standard treatment of total wrist denervation, offering potential hope for patients suffering from this debilitating condition.

Table of Contents

What is Autologous Microfat?

Autologous microfat is a substance derived from your own body fat. The term “autologous” means it comes from your own tissues. This fat is carefully processed to create a concentrated form that can be used for medical treatments.[1]

Treatment Combination: Autologous Microfat and Platelet-Rich Plasma

The treatment being studied combines autologous microfat with another substance called platelet-rich plasma (PRP). PRP is a concentration of platelets from your own blood, which contains growth factors that can help in healing.[1]

This combination is referred to as “MICROFAT 2 mL AND PLATELET RICH PLASMA HUMAN 2 mL MIXTURE” in the clinical trial. It’s a suspension for injection, meaning it’s a liquid that can be injected into the body.[1]

Medical Condition: Radiocarpal Osteoarthritis

The treatment is being studied for radiocarpal osteoarthritis. This is a type of arthritis that affects the wrist joint, specifically where the forearm bones (radius and ulna) meet the first row of bones in the wrist. It causes pain, stiffness, and can limit wrist movement.[1]

How the Treatment Works

The treatment involves injecting the mixture of autologous microfat and platelet-rich plasma directly into the affected wrist joint. This is called an intra-articular injection. The idea is that these substances may help reduce pain and improve joint function, potentially by promoting healing and reducing inflammation.[1]

Clinical Trial Details

A clinical trial is being conducted to evaluate this treatment. Here are some key points about the trial:

  • It’s a Phase 2 clinical trial, which means it’s testing the effectiveness and safety of the treatment.[1]
  • The main goal is to see if this treatment is as good as (non-inferior to) a standard treatment called total wrist denervation in reducing pain after 6 months.[1]
  • The trial will also look at safety, patient satisfaction, and how well the treatment works at 3, 6, and 12 months.[1]
  • Some patients will have MRI scans to see if there are improvements in the cartilage of the wrist.[1]

Eligibility Criteria

To participate in this trial, patients need to meet certain criteria. Some key points include:

  • Being 18 years or older[1]
  • Having wrist osteoarthritis that causes significant pain (40mm or more on a 100mm pain scale)[1]
  • Having tried other treatments for at least a year without success[1]

There are also several conditions that would prevent someone from participating, such as certain medical conditions or use of specific medications.[1]

Potential Benefits

While the effectiveness of this treatment is still being studied, potential benefits might include:

  • Reduced pain in the wrist[1]
  • Improved wrist function and mobility[1]
  • Better quality of life due to improved wrist condition[1]

Safety Considerations

The trial will closely monitor patients for any side effects or complications. Some important safety points:

  • The treatment uses your own tissues, which may reduce the risk of rejection or allergic reactions.[1]
  • Patients will be checked for certain infectious diseases before treatment.[1]
  • People with certain medical conditions or those taking specific medications may not be eligible for safety reasons.[1]

It’s important to note that this is an experimental treatment, and its full effects and potential risks are still being studied.[1]

Aspect Details
Study Type Phase 2 Clinical Trial, Randomized Controlled Non-inferiority Trial
Condition Radiocarpal Osteoarthritis
Experimental Treatment Intra-articular injection of Autologous Microfat (2 mL) combined with Platelet-Rich Plasma (2 mL)
Control Treatment Total Wrist Denervation (standard treatment)
Primary Outcome Pain reduction measured by Visual Analog Scale (VAS) at 6 months
Secondary Outcomes Safety, efficacy at 3, 6, and 12 months, patient satisfaction, relationship between product characteristics and clinical improvement
Inclusion Criteria Adults ≥18 years, symptomatic wrist osteoarthritis, pain ≥40mm on VAS, failure of medical treatment for at least one year
Key Exclusion Criteria Recent use of certain medications, history of wrist surgery for osteoarthritis, immune deficiencies, active infections, pregnancy
Follow-up Duration 12 months

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to determine if intra-articular injections of autologous microfat and PRP are as effective as total wrist denervation in treating radiocarpal osteoarthritis that hasn't responded to medical treatment. The study will primarily focus on pain reduction after 6 months.
  • Who can participate in this clinical trial? Participants must be adults (18 years or older) with symptomatic wrist osteoarthritis that hasn't improved with at least one year of medical treatment. They should have pain levels of 40mm or higher on a visual analog scale and meet specific radiographic criteria.
  • What does the experimental treatment involve? The experimental treatment consists of an intra-articular injection of a mixture containing 2 mL of autologous microfat (fat tissue from the patient's own body) and 2 mL of platelet-rich plasma (PRP) derived from the patient's blood.
  • How long will participants be followed in this study? Participants will be followed for 12 months after treatment. Assessments will be conducted at 7 days, 3 months, 6 months, and 12 months to evaluate safety, efficacy, and patient satisfaction.
  • What are some reasons why someone might not be able to participate in this trial? Exclusion criteria include recent use of certain medications (like antiplatelet drugs or NSAIDs), history of wrist surgery for osteoarthritis, immune deficiencies, active infections, pregnancy, and certain medical conditions that might interfere with the treatment or its evaluation.

Ongoing Clinical Trials on Autologous Microfat

  • Study of Autologous Microfat and Platelet-Rich Plasma Injection Compared to Wrist Denervation in Patients with Radiocarpal Osteoarthritis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Autologous Microfat: Fat tissue harvested from a patient's own body, typically through a minor liposuction procedure, which is then processed and used for therapeutic purposes.
  • Platelet-Rich Plasma (PRP): A concentrated form of plasma from a patient's own blood that contains a high number of platelets, which are rich in growth factors and can potentially aid in healing and tissue regeneration.
  • Radiocarpal Osteoarthritis: A degenerative joint disease affecting the wrist, specifically the joint between the radius (forearm bone) and the first row of carpal bones in the wrist.
  • Intra-articular Injection: A medical procedure where a substance is injected directly into a joint space, in this case, the wrist joint.
  • Total Wrist Denervation: A surgical procedure that involves cutting specific nerves to the wrist to reduce pain associated with osteoarthritis while maintaining wrist function.
  • Visual Analog Scale (VAS): A measurement tool used to assess pain intensity, typically represented as a line with one end meaning no pain and the other end meaning worst possible pain.
  • Non-inferiority Trial: A type of clinical trial designed to demonstrate that a new treatment is not worse than a standard treatment by more than a pre-specified margin.
  • Kellgren and Lawrence Classification: A system used to grade the severity of osteoarthritis on a scale from 0 to 4, based on radiographic findings.
  • DISI (Dorsal Intercalated Segment Instability): A type of wrist instability where there is an abnormal alignment of the carpal bones, often associated with ligament injuries or arthritis.
  • Pseudarthrosis: A condition where a fracture fails to heal properly, resulting in a 'false joint' at the fracture site.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-autologous-microfat-and-platelet-concentrate-injections-for-patients-with-wrist-osteoarthritis-resistant-to-medical-treatment/