PMID- 33404700
OWN - NLM
STAT- MEDLINE
DCOM- 20210423
LR  - 20220531
IS  - 1432-5195 (Electronic)
IS  - 0341-2695 (Linking)
VI  - 45
IP  - 2
DP  - 2021 Feb
TI  - Intra-articular gold induced cytokine (GOLDIC(R)) injection therapy in patients 
      with osteoarthritis of knee joint: a clinical study.
PG  - 497-507
LID - 10.1007/s00264-020-04870-w [doi]
AB  - PURPOSE: To evaluate the safety and efficacy of a novel technique of 
      preconditioning autologous blood with gold particles (GOLDIC(R)) 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(R) 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(R) as a novel device for conservative management of moderate to 
      severe KOA was confirmed. GOLDIC(R) produces rapid and sustained improvements in 
      all indices after treatment, with no SAEs. TRIAL REGISTRATION:  section sign 13 Abs.2b AMG 
      Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)-Date 3/20/2010 
      retrospectively registered.
FAU - Schneider, Ulrich
AU  - Schneider U
AUID- ORCID: 0000-0002-2252-5188
AD  - iRegMed, Tegernsee, Germany.
FAU - Kumar, Ashok
AU  - Kumar A
AUID- ORCID: 0000-0002-6456-3342
AD  - My Doc Specialist Medical Centre DMCC, Fortune Executive Tower, JLT, Dubai, 
      United Arab Emirates.
FAU - Murrell, William
AU  - Murrell W
AUID- ORCID: 0000-0001-8835-1806
AD  - Abu Dhabi Knee and Sports Medicine, Healthpoint Hospital, Zayed Sports City, Abu 
      Dhabi, United Arab Emirates. doctormurrell@gmail.com.
AD  - Department of Orthopedic Surgery, Division of Surgery, William Beaumont Army 
      Medical Center, Ft. Bliss, TX, USA. doctormurrell@gmail.com.
FAU - Ezekwesili, Agnes
AU  - Ezekwesili A
AUID- ORCID: 0000-0003-2082-1087
AD  - Department of Nutrition, University of North Carolina, Chapel Hill, NC, USA.
FAU - Yurdi, Nagib A
AU  - Yurdi NA
AUID- ORCID: 0000-0002-4233-6069
AD  - Abu Dhabi Knee and Sports Medicine, Healthpoint Hospital, Zayed Sports City, Abu 
      Dhabi, United Arab Emirates.
FAU - Maffulli, Nicola
AU  - Maffulli N
AUID- ORCID: 0000-0002-5327-3702
AD  - Department of Musculoskeletal Disorders, University of Salerno School of Medicine 
      and Dentistry, Salerno, Italy.
AD  - 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.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20210106
PL  - Germany
TA  - Int Orthop
JT  - International orthopaedics
JID - 7705431
RN  - 0 (Cytokines)
RN  - 7440-57-5 (Gold)
SB  - IM
MH  - Cytokines
MH  - Gold/therapeutic use
MH  - Humans
MH  - Injections, Intra-Articular
MH  - Knee Joint/diagnostic imaging/surgery
MH  - Middle Aged
MH  - *Osteoarthritis, Knee/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bone marrow aspirate concentrate
OT  - Goldic
OT  - Knee general
OT  - Pain management
OT  - Platelet-rich plasma
OT  - Stem cell therapy
EDAT- 2021/01/07 06:00
MHDA- 2021/04/24 06:00
CRDT- 2021/01/06 12:18
PHST- 2020/06/13 00:00 [received]
PHST- 2020/11/03 00:00 [accepted]
PHST- 2021/01/07 06:00 [pubmed]
PHST- 2021/04/24 06:00 [medline]
PHST- 2021/01/06 12:18 [entrez]
AID - 10.1007/s00264-020-04870-w [pii]
AID - 10.1007/s00264-020-04870-w [doi]
PST - ppublish
SO  - Int Orthop. 2021 Feb;45(2):497-507. doi: 10.1007/s00264-020-04870-w. Epub 2021 
      Jan 6.