Emerging Data

Emerging Data

Source: Anz AW, et al. Paper 12. Presented at: Arthroscopy Association of North America and American Orthopaedic Society for Sports Medicine Specialty Day; March 17 and 18, 2021 (virtual meeting).
Disclosures: Anz reports no relevant financial disclosures.
May 12, 2021
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Cell-based intervention appears to be effective in large knee articular cartilage defects

Source: Anz AW, et al. Paper 12. Presented at: Arthroscopy Association of North America and American Orthopaedic Society for Sports Medicine Specialty Day; March 17 and 18, 2021 (virtual meeting).
Disclosures: Anz reports no relevant financial disclosures.
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Use of a stem cell-based articular regeneration technology may be safe and effective in the treatment of large knee cartilage defects, according to a presenter.

“Large cartilage defects can be appropriately treated with this emerging cartilage repair technology that combines arthroscopic marrow stimulation with postoperative injections of autologous stem cells,” Adam W. Anz, MD, an orthopedic surgeon at Andrews Institute Orthopaedics and Sports Medicine, told Healio Orthopedics.

Articular regeneration vs hyaluronic acid

In an FDA-observed investigational, new drug, phase 2B study, Anz and his colleagues randomly assigned 81 patients with cartilage defects of the knee greater than 3 cm2 to receive treatment with either an articular regeneration technology consisting of autologous peripheral blood stem cells with hyaluronic acid (KLSMC Stem Cells Inc.; n=43) or hyaluronic acid alone (n=38).

Both groups of patients also underwent post-treatment physiotherapy.

Adam W. Anz
Adam W. Anz

“At our interim analysis, in terms of those who had reached 24-month follow-up, we had 35 [patients] in the intervention group and 33 [patients] in the control group,” Anz said at the Arthroscopy Association of North America and American Orthopaedic Society for Sports Medicine Specialty Day, where he presented the findings.

IKDC, KOOS scores

Primary outcome measures used included IKDC scores and the KOOS pain subdomain. Secondary outcome measures used included magnetic resonance observation of cartilage repair tissue (MOCART) scores and numerical rating scale (NRS) pain scores.

“Our primary outcome measures of the subjective International Knee Documentation Committee score showed a statistical significance at 18 months and 24 months,” Anz said in his presentation.

The KOOS pain subdomain also showed statistical significance at 12 months, 18 months and 24 months after articular regeneration treatment. MOCART scores showed statistical significance at 12-month and 24-month follow-up, while NRS pain scores showed statistical significance starting at the 6-month follow-up, which continued to improve until the 24-month follow-up, according to Anz.

“At the interim analysis, there was statistical significance favoring the intervention group such that we stopped the study because the findings were there, that the intervention was superior to the control group,” Anz told Healio Orthopedics.

Potential of regeneration technology

Anz told Healio Orthopedics he believes articular regeneration technology may impact the field of orthopedics on multiple levels, in addition to its use to treat large cartilage defects of the knee. The technology has the potential to be “the best method to harvest and store cells with stem potential for multiple applications,” he said.

“Everything else has hurdles and [articular regeneration technology] … is the same [method] for stem cell harvest as for bone marrow transplant,” Anz said. “So, it is something that has been around for a while. We are just applying it to orthopedic sports medicine. It is potentially a way that we could change how we think about applying stem cells for multiple orthopedic indications because it is a readily available source that can be cryopreserved and used multiple times.”

Reference:

Efficacy and safety study of intra-articular injections of autologous peripheral blood stem cells following subchondral drilling surgery for the treatment of articular cartilage injury in the knee. Available at: https://clinicaltrials.gov/ct2/show/NCT03101163?term=KLSMC+Stem+Cells+Inc&draw=2&rank=1. Accessed April 30, 2021.