T. Saris (Utrecht, NL)
University Medical Centre UtrechtPresenter Of 1 Presentation
16.1.3 - Five-year follow-up of the IMPACT trial: One-stage cell based cartilage repair using recycled chondrons and allogeneic MSCs
Abstract
Purpose
This study reports the 5-year follow-up of clinical efficacy and longevity, after treatment of symptomatic cartilage defects in the knee with mesenchymal stromal cells (MSCs) mixed with recycled chondrons in the first-in-man one-stage cartilage repair (IMPACT).
Methods and Materials
This study is an academically funded phase I/II prospective mono-center study, investigating the feasibility and safety of cartilage repair procedure. Between 2013 and 2014, a total of 35 patients (mean age 30±8 years) with an average follow up of 60 months (39-70) were treated with the Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) one-stage cartilage repair procedure for a symptomatic cartilage defect on the femoral condyle or trochlea. Subsequent follow-up was performed yearly through online questionnaires. PROMs included the Knee injury and Osteoarthritis Outcome score (KOOS), Visual Analogue Scale for pain (VAS) and the EuroQol-5D (EQ5D) at 3, 6, 12, 18, 24, 36, 48 and 60 months. All clinical data, including additional treatment received after the index surgery, were recorded and will be complete in August 2019.
Results
After five years, no signs of a foreign body response were recorded and no serious adverse reactions were found. The vast majority of patients showed statistically significant clinical improvement in the KOOS (mean improvement from baseline 57.9±16.1 to 85.4±13.3 at 18 months and 79.1±17.9 at 60 months [p <.01]. The VAS pain score improved from baseline (45.3 ±23.6) to 18 months (9.7±14.7 [p < .0001]) and 60 months (15.5±13.1). 5 incidents of IMPACT failure were found after 5 years. 4 of these required additional treatment (2 autologous conditioned plasma injections, 1 MaioRegen, 1 unknown surgery elsewhere).
Conclusion
This is the first study showing long-term safety and efficacy of the proof of concept that allogeneic MSCs augment one‐stage articular cartilage repair. The absence of serious adverse events and the clinical outcome support the longevity of this unique concept. These data support IMPACT as a safe, and reliable solution for articular chondral defects in the knee.