Mytocel MSKUnited Kingdom
Rigeneracons device grid held in a sterile glove

Safety

Autologous, minimally manipulated, and reported without serious adverse events in the published series.

Mytocel MSK® is autologous and minimally manipulated, so no donor material and no immunological rejection. No serious adverse events were reported in the four published knee series (combined n = 37), and donor sites healed within about a week without sutures.

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Sources1234

What to expect

Expected effects and recovery.

A clinician holding an ultrasound probe on a patient’s knee, with a syringe held clear of the skin
Administration under ultrasound guidance, illustrative
Expected effects
Expected: transient discomfort at the auricular donor site; the usual risks of intra-articular injection including local inflammation, pain and, rarely, infection.
Recovery
Outpatient procedure; most patients return to daily activity within one to two days and the donor site heals in one to two weeks (manufacturer-stated).

Contraindications

Exclusions in brief.

  • Inflammatory rheumatism (positive ANA, ASLO > 150, positive rheumatoid factor, history of inflammatory rheumatism)
  • Morbid obesity
  • Uncontrolled diabetes
  • Severe metabolic disease
  • Grade IV osteoarthritis
  • Corticosteroid or intra-articular injection within the previous 3 months

Full criteria in the professional protocol and the instructions for use.

Full patient-selection criteria

Vigilance

Report incidents and complaints.

Report suspected incidents and product complaints to Actomed, which forwards them to the manufacturer for assessment and, where required, reporting to the MHRA.

Report to Actomed
The single-use Rigeneracons RS device photographed on a plain white background.
Single-use device: report lot-level issues to Actomed

References

  1. 1.Dorta Fernández A, Baroni Luengo A, et al. Biostimulation of knee cartilage using autologous micrografts. Rehabilitation Science. 2018;3(1). Reproduced in the Mytocel MSK scientific studies booklet, p. 43. View source
  2. 2.Marcarelli M, Zappia M, Rissolio L, et al. Cartilage micrografts as a novel non-invasive and non-arthroscopic autograft procedure for knee chondropathy: three-year follow-up. J Clin Med. 2021;10(2):322. View source
  3. 3.Tsoukas D, Muntean I, Simos C, Sabido-Vera R. Prospective observational study of a non-arthroscopic autologous cartilage micrografting technology for knee osteoarthritis. Bioengineering. 2023;10(11):1294. View source
  4. 4.Helito CP, Pessei V, Zaniboni C, Muntean I, et al. Efficacy of autologous micrografting technology in managing osteoarthritis pain: a pilot study. Bioengineering. 2024;11(11):1119. View source

Supported from the first case.

Actomed supplies Mytocel MSK in the UK with protocol training, equipment orientation, first-case support and a direct route for reporting incidents and complaints.

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