Autologous Chondrocytes

Clinical trials investigating “Autologous Chondrocytes” are studying treatment for knee cartilage damage, especially symptomatic lesions in the femoral condyles or trochlea. The trials mainly look at whether the treatment improves symptoms and quality of life compared with standard care, and they include adults with focal articular cartilage defects.

Table of contents

Trial overview

The provided trial studied Autologous Chondrocytes in a knee cartilage condition called a symptomatic articular cartilage lesion.[1] The study compared this treatment with conservative care, meaning non-surgical treatment such as optional physical therapy and pain medicine.[1]

This was a randomized controlled trial, which means patients were assigned by chance to a treatment group so the results could be compared fairly.[1] The trial was completed and included 60 participants.[1]

Who was studied

The target population was people with a symptomatic articular cartilage lesion of the knee.[1] The trial specifically mentions lesions in the femoral condyles or the trochlea, which are parts of the knee joint.[1]

In simple terms, this means the study focused on people whose knee cartilage damage was causing symptoms such as pain or reduced function.[1]

What was tested

The intervention in the trial was an intra-articular injection of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT).[1] The source data list the dose as 1.4 ml/cm2 and describe it as an injection into the joint.[1]

The study compared IMPACT with standard care, which could include physical therapy and pain medication, but no surgical treatment.[1] The purpose was to see whether the treatment led to better clinical improvement and better quality of life than standard care.[1]

Outcomes measured

The main outcome was clinical improvement and quality of life after 3, 6, and 9 months.[1] These were measured using KOOS and EQ5D, which are questionnaires used to track knee-related symptoms and general health status.[1]

  • KOOS: a questionnaire that helps measure knee symptoms, pain, daily activities, sports and recreation, and quality of life.[1]
  • EQ5D: a questionnaire that helps measure general health and quality of life.[1]

Trial design and phase

The study was an interventional trial, which means the researchers actively gave a treatment and then measured the results.[1] It was in Phase 3, a later-stage phase that usually tests treatment effects in a larger group and compares them with another approach.[1]

The trial status is listed as completed, so the study has already finished collecting its data.[1]

What the results are meant to show for patients

For patients, this trial is mainly about whether Autologous Chondrocytes-related treatment can help people with knee cartilage damage feel better and live better in daily life.[1] The comparison with standard care helps show whether the treatment offers added benefit beyond non-surgical care.[1]

The study does not focus on many different diseases or patient groups; it is specifically about knee cartilage lesions with symptoms.[1] Based on the source data, the key question is not just whether the treatment can be given, but whether it improves patient-reported outcomes over time.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-514612-27-01Phase 3Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea)Completed60

Igangværende kliniske forsøg for Autologous Chondrocytes

  • Sammenligning af IMPACT-behandling og standardbehandling for patienter med bruskskader i knæet

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Holland

Ordliste

  • Articular cartilage: The smooth tissue that covers the ends of bones in a joint and helps the joint move easily.
  • Knee cartilage lesion: An area of damage in the cartilage of the knee.
  • Symptomatic: Causing symptoms, such as pain, swelling, or trouble moving.
  • Femoral condyles: Rounded parts at the lower end of the thigh bone that form part of the knee joint.
  • Trochlea: A groove-like part of the knee joint where the kneecap moves.
  • Randomized controlled trial: A study where patients are assigned by chance to different treatment groups so results can be compared fairly.
  • Conservative treatment: Non-surgical care, such as physical therapy and pain medicine.
  • Clinical improvement: A decrease in symptoms or better function after treatment.
  • Quality of life: How well a person feels and functions in daily life.
  • KOOS: A questionnaire used to measure knee symptoms, pain, daily function, sports ability, and quality of life.
  • EQ5D: A questionnaire used to measure general health and quality of life.

Referencer