Mesenchymal Progenitor Cells and Their Orthopedic Applications: Forging a Path towards Clinical Trials
Table 1
Clinical studies of bone marrow aspirates in osteonecrosis.
Authors
Year
Study
Description
Main findings
Hernigouet al.
1997
Case report
13-year-old with SSA and ON of humeral head treated with allogenic bone marrow transplantaion
Improvement in pain and motion range; X-Rays at 3 months showed significant regeneration of the proximal humerus and epiphysis
Hernigouet al.
2002 2005
Prospective noncontrol
189 hips in 116 patients were treated with core decompression and with ABM harvested from anterior iliac crests; the aspirated marrow was reduced in volume by concentration and injected into the femoral head after core decompression with a small trocar; followup of 5–10 years
In 145 of the stage I/II patients, hip replacement was required in 9; total hip replacement was necessary in 25 of 44 hips operated on at stage III/IV patients with greater number of OPGr cells transplanted had better outcomes
Gangi et al.
2002
Prospective control
Treatment of 18 hips with stage 1 or 2 (ARCO) femoral head ON with either core decompression alone or in combination with ABM injection
Significant reduction in pain and joint symptoms at 2 years; 5 of 8 hips in control group deteriorated to stage 3 compared to 1 hip in treatment arm
Yan et al.
2006
Prospective noncontrol
Treatment of 44 hips with stage 3 or 4 (ARCO) femoral head ON with ABM injection
Mean Harris hip score improved from 58 (46–89) to 86 (70–94) at 2 years; no complications
Kawate et al.
2006
Case reports
Treatment of 3 patients with steroid-induced ON of femoral head (ARCO Stages 4A–4C) by transplantation of autologous MSCs cultured with beta-tricaclium phosphate ceramics and free vascularized fibulas
Early bone regeneration observed but radiographic progression was seen in 2 of 3 patients at mean followup of 34 months
Lee et al.
2009
Case reports
Three patients with bilateral, large lesions (0.32 of femoral width) of ON of the femoral condyles treated by decompression, debridement, and ABM grafting using the Cellect DBM System to increase the number of OPGr cells from the aspirate
Cellect provided graft matrix enriched with a 3-fold to 4-fold increase in OPGr cells; no complications at 2 years with all 3 patients achieving near-normal function and activity levels
ABM: autologous bone marrow; ARCOL: association research circulation osseous; OPGr: osteoprogenitor; SSA: sickle cell anemia.