Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Journal of Orthopaedic Surgery and Research
Christoph BecherJakob Fay

Abstract

This study was conducted to assess the efficacy and safety of the three dose levels of the three-dimensional autologous chondrocyte implantation product chondrosphere® in the treatment of cartilage defects (4-10 cm2) of knee joints. We hereby report the safety results for a 36-month post-treatment observation period. This was a prospective phase II trial with a clinical intervention comprising biopsy for culturing spheroids and their subsequent administration (level of evidence: I). Patients' knee defects were investigated by arthroscopy, and a cartilage biopsy was taken for culturing. Patients were randomised, on a single-blind basis, to treatment at the dose levels 3-7 (low), 10-30 (medium) or 40-70 (high) spheroids per square centimetre. Assessment (adverse events, vital signs, electrocardiography, physical examination, concomitant medication and laboratory values) took place 1.5, 3, 6, 12, 24 and 36 months after chondrocyte implantation. Seventy-five patients were included and 73 treated. The incidence of adverse events, of patients with adverse events and of patients with treatment-related adverse events showed no relevant difference between the treatment groups. There were no fatal adverse events, no adverse events led to...Continue Reading

References

Oct 6, 1994·The New England Journal of Medicine·M BrittbergL Peterson
Jan 19, 2002·The American Journal of Sports Medicine·Lars PetersonAnders Lindahl
May 2, 2003·The Journal of Bone and Joint Surgery. American Volume·Mats Brittberg, Carl S Winalski
Mar 3, 2006·The Journal of Bone and Joint Surgery. American Volume·Jennifer J WoodTimothy R Coté
Dec 20, 2008·Journal of Biomedical Materials Research. Part a·Peter BernsteinStefan Fickert
Sep 13, 2011·The American Journal of Sports Medicine·Johan VanlauweUNKNOWN TIG/ACT/01/2000&EXT Study Group
Dec 26, 2015·Knee Surgery, Sports Traumatology, Arthroscopy : Official Journal of the ESSKA·Rainer SieboldFrancis Fernandez

❮ Previous
Next ❯

Citations

Mar 13, 2019·Journal of Biomedical Materials Research. Part B, Applied Biomaterials·Tobias LamLutz Kloke
Aug 28, 2019·Annals of Biomedical Engineering·Lise De MoorHeidi Declercq
Jul 13, 2019·Nature Reviews. Rheumatology·Heenam KwonKyriacos A Athanasiou
May 24, 2018·Journal of Experimental Orthopaedics·Ibrahim Fatih CengizJoaquim Miguel Oliveira
Sep 14, 2018·International Journal of Molecular Sciences·Mikko J LammiChengjuan Qu
Jan 4, 2020·Knee Surgery, Sports Traumatology, Arthroscopy : Official Journal of the ESSKA·Philipp NiemeyerStefan Fickert
Apr 17, 2020·EFORT Open Reviews·Mukai Chimutengwende-GordonGeorge Bentley
Oct 6, 2020·Orthopaedic Journal of Sports Medicine·Moritz RiedlVincenco Denaro
Jan 14, 2018·Journal of Experimental Orthopaedics·Kazunori ShimomuraNorimasa Nakamura
Apr 12, 2020·Knee Surgery, Sports Traumatology, Arthroscopy : Official Journal of the ESSKA·David GrevensteinChristoph Brochhausen
Jan 5, 2021·Frontiers in Cell and Developmental Biology·Roya RamezankhaniEnsiyeh Hajizadeh-Saffar
Nov 20, 2018·Biomaterials·Valeria GraceffaDimitrios I Zeugolis
Sep 3, 2021·Journal of Orthopaedic Surgery and Research·Filippo MiglioriniNicola Maffulli
Sep 24, 2021·British Medical Bulletin·Filippo MiglioriniNicola Maffulli
Oct 5, 2021·Tissue Engineering. Part B, Reviews·Sarah M Cooper, Roshni S Rainbow

❮ Previous
Next ❯

Methods Mentioned

BETA
biopsy
pregnancy tests

Software Mentioned

SAS

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.