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Intra-articular gold induced cytokine (GOLDIC®) injection therapy in patients with osteoarthritis of knee joint: a clinical study

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Abstract

Purpose

To evaluate the safety and efficacy of a novel technique of preconditioning autologous blood with gold particles (GOLDIC®) and injection in patients with moderate to severe knee osteoarthritis (KOA).

Methods

During this phase 2a, proof-of-concept (PoC) open label study, 83 consecutive patients that 64 patients met inclusion criteria (mean age: 64.8 years; 89 knees) with radiographically proven KOA, received four ultrasound guided intra-articular knee injections of GOLDIC® at three to six day intervals. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) were evaluated at baseline, four weeks, three, six months, one, two and four years (T1–T6). The incidence of treatment related severe adverse events (SAEs) recorded. Intra-articular gelsolin level in patients with effusion was determined.

Results

KOOS and WOMAC scores improved for the full duration of the study (P < 0.05), minimal clinically important difference (MCID) was observed at all time points in all KOOS subscores, with no reported SAEs. Intra-articular gelsolin level increased after treatment with reduction of effusion. No statistically significant evidence of an association between patient demographics and outcome were identified. Nine patients failed treatment, with 32 months mean time to failure and underwent total knee arthroplasty.

Conclusion

PoC study of GOLDIC® as a novel device for conservative management of moderate to severe KOA was confirmed. GOLDIC® produces rapid and sustained improvements in all indices after treatment, with no SAEs.

Trial registration

§ 13 Abs.2b AMG Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)—Date 3/20/2010 retrospectively registered.

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Data availability

Underlying data from this manuscript may be requested by qualified researchers upon request. Investigators may request access to deidentified patient data and redacted study documents which may include raw datasets, analysis-ready data sets, and blank data forms. Prior to the use of data, proposals need to be approved by an independent review panel at www.clinicalstudyrequest.com and a signed data sharing agreement will need to be executed. Some documents are available in German and others English.

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Acknowledgments

The authors would like to thank Eduard Collier, Nico Nagelkerk PhD, Pam Jackson PhD, Lisa Jackson PhD for their contributions to this scientific work. Contributors US was the coordinating investigator, WDM contributed to the study conduct and/or data collection.

Author information

Authors and Affiliations

  1. iRegMed, Tegernsee, Germany

    Ulrich Schneider

  2. My Doc Specialist Medical Centre DMCC, Fortune Executive Tower, JLT, Dubai, United Arab Emirates

    Ashok Kumar

  3. Abu Dhabi Knee and Sports Medicine, Healthpoint Hospital, Zayed Sports City, Abu Dhabi, United Arab Emirates

    William Murrell & Nagib A. Yurdi

  4. Department of Orthopedic Surgery, Division of Surgery, William Beaumont Army Medical Center, Ft. Bliss, TX, USA

    William Murrell

  5. Department of Nutrition, University of North Carolina, Chapel Hill, NC, USA

    Agnes Ezekwesili

  6. Department of Musculoskeletal Disorders, University of Salerno School of Medicine and Dentistry, Salerno, Italy

    Nicola Maffulli

  7. Barts and the London School of Medicine and Dentistry Centre for Sports and Exercise Medicine, Mile End Hospital, Queen Mary University of London, London, England, UK

    Nicola Maffulli

Authors
  1. Ulrich Schneider
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  2. Ashok Kumar
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Contributions

All authors analyzed and/or interpreted data. All authors collaborated in the drafting and critical revision of the manuscript. All authors approved the final version of the manuscript and vouch for the accuracy of the analysis and the fidelity of the study to the protocol.

Corresponding author

Correspondence to William Murrell.

Ethics declarations

Ethics approval

Competent authority of Bavaria authorized the study.

Consent to participate

All patients were approved for treatment by written informed consent.

Consent for publication

Written informed consent was obtained from all patients.

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Supplementary information

ESM 1

Supplementary Data A. Mean KOOS and WOMAC scores at baseline data for all study participants K-L grades 2 and 3, and follow-up at 4 weeks, 3, 6 months, 1, 2, and 4 years. Kolmogorov-Smirnov-Test shows no significant deviation compared to a normal distribution; red indicates significant mean differences (α < 0.05). Supplementary Data B. Mean KOOS and WOMAC scores at baseline data for all study participants K-L grade 4, and follow-up at 4 weeks, 3, 6 months, 1, 2, and 4 years. Kolmogorov-Smirnov-Test shows no significant deviation compared to a normal distribution; red indicates significant mean differences (α < 0.05). (XLS 32 kb)

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Schneider, U., Kumar, A., Murrell, W. et al. Intra-articular gold induced cytokine (GOLDIC®) injection therapy in patients with osteoarthritis of knee joint: a clinical study. International Orthopaedics (SICOT) 45, 497–507 (2021). https://doi.org/10.1007/s00264-020-04870-w

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  • DOI: https://doi.org/10.1007/s00264-020-04870-w

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