Plasmaconcept AG Prepares Circles for 2022 Post-Market Surveillance Strategy

November 2, 2021

Plasmaconcept AG, headquartered in Köln, Germany, has chosen Circles to conduct a multi-center, post-market surveillance study on its IM.P.A.C.T. platform for autologous cell therapies. 

Working with multiple independent European customer sites, and under ethics committee approval, Plasmaconcept AG will aggregate longitudinal outcomes data from real-world patients suffering from tendinopathy and osteoarthritis of various joints. Patient compliance in this real-world study will be a key factor, so Plasmaconcept AG will be taking steps to ensure:

  1. Patients are regularly assigned patient reported outcomes measures (PROMs) to be completed electronically from their home and/or mobile devices for up to two years post-treatment.
  2. Engagement and compliance are increased through automated communications in their native German language, live feedback on their reported scores and long-term tracking of their progress over time.
  3. A Clinical Research Organization (CRO) handles telephonic follow-ups for patients who are of an advanced age, have issues with technology, or are simply unresponsive to multiple follow-ups.

Complementing this strong patient follow-up regimen are key clinical criteria, such as the specific dosages of erythrocytes, leukocytes and platelets chosen for each patient/indication. Such data will require less than a minute of work per site per patient but will support meaningful correlations which advance working knowledge on autologous cell therapy dosages.

Plasmaconcept AG anticipates ethics committee approval before close of 2021 and will be launching its Circle in early 2022.

If you would like more information about Plasmaconcept AG, its IM.P.A.C.T. device, or its post-market surveillance Circles, contact us here.

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