Grafting of autologous concentrated bone marrow processed using a point-of-care device for patients with osteonecrosis of the femoral head: A phase 1 feasibility and safety study.
Regen Ther
; 20: 18-25, 2022 Jun.
Article
en En
| MEDLINE
| ID: mdl-35350421
ABSTRACT
Introduction:
Along with the accumulating reports of autologous concentrated bone marrow (CBM) grafting for osteonecrosis of the femoral head (ONFH), the related medical device, a "point-of-care device" has also been recently developed. However, no study has confirmed the feasibility, safety, and efficiency of CBM grafting using a specific point-of-care device. Materials andmethods:
We designed this phase I, prospective clinical study to evaluate the feasibility and safety of autologous CBM grafting processed using a point-of-care device, the BioCUE system, in patients with ONFH. The primary outcomes were the safety and adverse event (AE), the secondary outcomes included pain score; hip function score; ONFH stage using X-ray; and the volume of the osteonecrotic area on 3T MRI. Besides, safety quality tests on the final product of concentrated bone marrow were performed.Results:
Two patients (a 34-year-old man and a 33-year-old woman; three hips) with systemic lupus erythematosus were included. The incidence of AEs was 100% such as pain or transient fever after the operation, but all AEs were nonserious. No peri-operative complications were observed. Pain and hip function score remained unchanged from the preoperative to the postoperative observational periods. Safety quality test demonstrated were all negative or under the threshold.Conclusion:
The feasibility and safety of grafting of concentrated autologous CBM in patients with ONFH using a point-of-care device were confirmed. A further clinical study aiming for the authorization of this procedure should be conducted in the future.
ADL, activity of daily living; AE, adverse event; Bone marrow; JHEQ, Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire; JICHW, Japanese Investigation Committee of Health and Welfare; ONFH, osteonecrosis of the femoral head; Osteonecrosis of the femoral head; Point-of-care device; VAS, visual analog scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index
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Banco de datos:
MEDLINE
Idioma:
En
Revista:
Regen Ther
Año:
2022
Tipo del documento:
Article
País de afiliación:
Japón