Mytocel MSKUnited Kingdom
A clinician’s gloved hands placing a single-use cartridge into the processing unit on a sterile drape

Clinical evidence

Clinical research. Reported outcomes. Three-year follow-up.

Every study behind Mytocel MSK® is listed here and linked in full. Published knee studies report improvements in pain and function, including a series with benefit maintained at three years and prospective studies following patients for twelve months. The scientific studies booklet brings together nine publications on clinical applications, cartilage biology and micrograft preparation, alongside additional manufacturer study summaries.

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3 years1

Follow-up in the knee chondropathy study (8 patients)

5 measures2

KOOS subscales improved at one and six months (10 patients)

12 months3

Pain and function follow-up in the pilot study (10 patients)

Four published knee reports describe outcomes in 37 patients. Patient numbers, study designs and follow-up periods are listed with each report.4

Studies at a glance

Track record of the technology

450,000+15

procedures, manufacturer-reported, across dermatology, wound care, dentistry and orthopaedics

70+15

countries, manufacturer-reported, across dermatology, wound care, dentistry and orthopaedics

10+16

years in clinical use, manufacturer-reported, across dermatology, wound care, dentistry and orthopaedics

Manufacturer-reported: Rigenera® technology has been used in more than 450,000 procedures in over 70 countries across dermatology, wound care, dentistry and orthopaedics, and has been in clinical use for more than ten years across those fields.

Published clinical series

Pain relief and knee function: the published clinical findings.

Peer-reviewed clinical

Marcarelli 2021, three-year knee series

Prospective uncontrolled case series · 8 patients · Follow-up: Six months and three years · OKS, VAS, MRI cartilage thickness

Eight patients with knee chondropathy (grade I to III). Mean Oxford Knee Score improved from 28.4 (SD 6) to 40.8 (SD 6.2); mean VAS pain from 5.5 (SD 1.6) to 1.8 (SD 0.7) at six months, with benefit reported as maintained at three years.1

Disclosure: Three authors are employees of the technology developer.

View source
OKS in Marcarelli 2021, three-year knee series: baseline 28.4, six months 40.8, Oxford Knee Score, points, standard deviations 6 and 6.2, 8 patients, uncontrolled.Oxford Knee Score, points05028.4BaselineSD 640.8Six monthsSD 6.2
8 patients, six months, uncontrolled1
VAS in Marcarelli 2021, three-year knee series: baseline 5.5, six months 1.8, VAS pain, 0 to 10 (lower is better), standard deviations 1.6 and 0.7, 8 patients, uncontrolled.VAS pain, 0 to 10 (lower is better)0105.5BaselineSD 1.61.8Six monthsSD 0.7
8 patients, six months, uncontrolled1
Peer-reviewed clinical

Tsoukas 2023, prospective knee osteoarthritis study

Prospective open-label observational study · 10 patients · Follow-up: Twelve months · KOOS (five subscales)

Ten patients with early-to-moderate knee OA, prospective open-label. KOOS improved across all five subscales at one and six months, covering pain, symptoms, daily activities, sport and quality of life.2

Disclosure: Medical writing funded by the manufacturer; kits supplied.

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Peer-reviewed clinical

Helito 2024, twelve-month pilot study

Pilot prospective observational study · 10 patients · Follow-up: Twelve months · VAS, KOOS, WOMAC

Ten-patient pilot; KOOS, WOMAC and VAS reported over twelve months. Mean VAS pain fell from 8.3 to 2.4 at one month and was 3.3 at twelve months; mean WOMAC from 54.8 to 24.4.3

Disclosure: No external funding declared.

View source
VAS in Helito 2024, twelve-month pilot study: baseline 8.3, twelve months 3.3, VAS pain, 0 to 10 (lower is better), 10 patients, uncontrolled.VAS pain, 0 to 10 (lower is better)0108.3Baseline3.3Twelve months
10 patients, twelve months, uncontrolled3
WOMAC in Helito 2024, twelve-month pilot study: baseline 54.8, twelve months 24.4, WOMAC, points (lower is better), 10 patients, uncontrolled.WOMAC, points (lower is better)05554.8Baseline24.4Twelve months
10 patients, twelve months, uncontrolled3

Imaging at three years

Cartilage thickness on MRI, reported for three of eight patients.

MRI thickness at three years, reported for three patients

Sagittal knee MRI plate at baseline
Sagittal, baseline
Sagittal knee MRI plate at three years
Sagittal, three years
Coronal knee MRI plate at baseline
Coronal, baseline
Coronal knee MRI plate at three years
Coronal, three years

MRI cartilage-thickness measurements at three years were reported for three patients and were mixed: increases in two (sagittal +15.2%, +9.3%; coronal +27.1%, +26.4%) and a decrease in one (sagittal -14.2%; coronal as printed -114%). The plates shown on this page are from one of the two patients whose measured thickness increased.1

Supporting research

Cartilage biology, micrograft preparation and emerging clinical research.

Research report

Dorta 2018, knee clinical series

Uncontrolled clinical series · 9 patients · Follow-up: Not stated in the abstract · WOMAC

Nine patients with knee osteochondral lesions; eight of nine improved in all WOMAC subdomains (median change 22 points).4

Disclosure: Published in a journal that is not indexed in PubMed; peer-review status unverified..

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Research report

Codorean, single-stage repair with a scaffold

Single-stage repair series combining micrografts with a tri-layer scaffold · Follow-up: Twelve months

The manufacturer’s study summary describes twelve-month follow-up after single-stage cartilage repair combining micrografts with a tri-layer scaffold.5

View source
Research report

Lacza, joint inflammatory environment

Inflammatory-marker study · Follow-up: Not stated · Inflammatory markers

The manufacturer’s study summary examines inflammatory markers in the joint environment after cartilage micrograft transplantation.6

View source
Pre-clinical

Desando 2021, rat osteochondral model

Pre-clinical animal study · Follow-up: Pre-clinical, no patient follow-up · Histology

Rat osteochondral-defect model with histological assessment; pre-clinical work supporting the rationale for cartilage-derived micrografts in osteochondral repair.7

View source
Pre-clinical

Viganò 2018, characterisation and equine model

Laboratory characterisation plus a three-horse pre-clinical evaluation · Follow-up: Pre-clinical, no patient follow-up · Micrograft characterisation, Cell viability

Laboratory characterisation describing a heterogeneous suspension of cartilage-derived cells (chondrocytes and progenitor cells), pericytes and extracellular-matrix components, with viability shown, plus a three-horse pre-clinical evaluation.8

View source
Mechanistic

Ceccarelli 2017, alar-nasal cartilage micrografts

In vitro and in vivo study · Follow-up: Not applicable · Micrograft preparation and characterisation

In vitro and in vivo cartilage micrograft preparation with the Rigenera protocol in an osteochondral-lesion context, exploring micrograft preparation and cartilage biology.9

View source
Mechanistic

Astarita 2020, review of tissue micrografts

Narrative review · Follow-up: Not applicable

Review of the biological foundations of tissue micrografts and the distinction between tissue micrografts and cultured, laboratory-expanded cells.10

View source
Panel A: histology of rat osteochondral defects, control and treated; panel B: box plot of O’Driscoll scores for the four groups
Pre-clinical rat osteochondral-defect model (Desando et al. 2021): histology and O’Driscoll scores, as reproduced in the manufacturer’s brochure. Animal-model histology and repair scores

Independent view

A 2025 systematic review brings together 55 studies of autologous micrografting across clinical applications, including three on cartilage or bone. Read the review for its synthesis of the findings, study methods and research directions.11

Registered trials

What is in progress.

Trial registry records, last reviewed September 2026. Follow each registry link for updates.
RegistryTitleSponsorDesignPlanned participantsStatus
ClinicalTrials.gov NCT0612368912Cartilage micrografts versus hyaluronic acidHuman Brain Wave S.r.l.RCT vs hyaluronic acid, KOOS at 6 months; 60 planned, 0 enrolled60Withdrawn, sponsor decision, June 2025
ClinicalTrials.gov NCT0775557913EAR2KNEERegenera Activa Worldwide with Orthosera and Semmelweis UniversitySingle arm, KOOS to 24 months, MRI at 6 months, synovial cytokines33Active, not recruiting; primary completion 21 Dec 2025; no results posted
ClinicalTrials.gov NCT0745395314Mytocel MSK versus PRPTaichung Veterans General HospitalRCT Mytocel MSK vs PRP, WOMAC at 52 weeks30Not yet recruiting; 2026 to 2030

Safety in the series

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 37 patients), and donor sites healed within about a week without sutures.4123

Safety profile

Documents

Read the sources.

Professional documents

  • HCP guide

    Professional protocol

    Open PDF

  • HCP guide

    Healthcare professional brochure

    Open PDF

  • HCP guide

    Four-stage quick guide

    Open PDF

  • FAQ

    Professional frequently asked questions

    Open PDF

  • Evidence pack

    Scientific studies booklet

    Open PDF

Study summaries

References

  1. 1.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
  2. 2.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
  3. 3.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
  4. 4.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
  5. 5.Codorean I, et al. Single-stage knee cartilage repair using auricular chondroprogenitor micrografts with a tri-layer scaffold: 12-month outcomes. Manufacturer study summary. View source
  6. 6.Lacza Z, et al. Autologous cartilage micrograft transplantation and the joint inflammatory environment. Manufacturer study summary. View source
  7. 7.Desando G, Grigolo B, et al. Intra-articular autologous cartilage micrografts for osteochondral repair. 2021. Reproduced in the Mytocel MSK scientific studies booklet, p. 31. View source
  8. 8.Viganò M, Tessaro I, Trovato L, et al. Rationale and pre-clinical evidence for autologous cartilage micrografts in cartilage repair. 2018. View source
  9. 9.Ceccarelli G, Gentile P, Marcarelli M, et al. Alar-nasal cartilage micrografts and the Rigenera protocol. 2017. Reproduced in the Mytocel MSK scientific studies booklet, p. 19. View source
  10. 10.Astarita C, Arora CL, Trovato L. Tissue regeneration: an overview from stem cells to micrografts. J Int Med Res. 2020. View source
  11. 11.Almujaydil, et al. Systematic review of autologous micrografting (55 studies, three on cartilage or bone). J Int Med Res. 2025. View source
  12. 12.ClinicalTrials.gov NCT06123689. Randomised trial of cartilage micrografts versus hyaluronic acid, KOOS at 6 months. Sponsor: Human Brain Wave S.r.l. Withdrawn, sponsor decision, June 2025. View source
  13. 13.ClinicalTrials.gov NCT07755579 (EAR2KNEE). Single-arm study of auricular cartilage micrografts for knee osteoarthritis, KOOS to 24 months. Sponsor: Regenera Activa Worldwide with Orthosera and Semmelweis University. View source
  14. 14.ClinicalTrials.gov NCT07453953. Randomised trial of Mytocel MSK versus platelet-rich plasma for knee osteoarthritis, WOMAC at 52 weeks. Sponsor: Taichung Veterans General Hospital. View source
  15. 15.Remedi (Regenera Activa). Mytocel MSK professional protocol. Manufacturer document. View source
  16. 16.Remedi. Mytocel MSK frequently asked questions. Manufacturer document. View source

Review the evidence with your team.

Actomed supports UK clinics collecting KOOS outcomes so the published picture keeps growing.

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