IMPACT study

A treatment that is less stressful for the patient - that is the aim of the IMPACT trial in the Mobility Clinic at UMC Utrecht. Usually, two surgeries are required for cartilage problems in the knee: one to take patient cells for culture in the lab, and a second to place the cells back into the knee. Thanks to a multidisciplinary collaboration of doctors, researchers, physiotherapists and a orthopedic surgeon, this can now be done in one single surgery.

Cartilage ensures the smooth movement of our joints. If the cartilage is damaged, rough bone surfaces move against each other and start to chafe. This causes an unpleasant pain, swelling, and can lead to serious complaints in the long term.

Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using patient-derived cartilage cells ("autologous chondrocyte implantation") has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase.

The IMPACT study has developed a one-step surgery with the aim to decrease surgical trauma, to lower complexity, and to improve logistics and cost-effectiveness, while retaining or improving clinical outcome. For more information, watch the video.

So far, IMPACT was successfully executed in a first-in-man phase I/II clinical trial, in which 35 participants with cartilage defects were treated. The results showed a good safety profile, proper feasibility and good initial clinical efficacy at 18 months follow-up. Also, good outcome at 24 and 36 months was shown in ongoing post study surveying of the participants. Watch the video (Dutch) on the right to see how IMPACT helped our patient Kevin to get back on track.

Due to the good outcomes, a new study with IMPACT has been designed: IMPACT2. The objective of IMPACT2 is to compare clinical outcomes with IMPACT to standard care for 9 months, consisting of optional physical therapy and pain medication. For more information, please refer to the official website of UMC Utrecht (Dutch) or clinicaltrials.gov.