Cellular therapies in patients with osteonecrosis
| Intervention/cell source . | Indication . | Study cohort . | Cell numbers . | Study design . | Classification . | Follow-up . | Outcome . | Reference . |
|---|---|---|---|---|---|---|---|---|
| CD and volume-reduced autologous bone marrow mononuclear cells | ON (steroids, alcohol, sickle cell disease) of the hip | 534 hips in 342 pts (16-61 y) | Average 24 × 103 CFUs | Single center, single arm | Steinberg stage I-II | 8-18 y | Stage I and II: total hip replacement 94/534 hips | 72 |
| CD ± bone marrow cells | Nontraumatic ON of the hip | 24 hips in 19 pts | CFU-F 92.6 ± 22.4 × 107/cells | Single center, randomized, blinded | ARCO I-II | 60 mo | Significant difference in the time to failure between CD alone and CD with bone marrow cells; significant reduction in pain and joint symptoms and reduced incidence of fractural stages in pts with CD with bone marrow cell implantation | 75 |
| CD ± autologous bone marrow mononuclear cells | Traumatic/nontraumatic (steroids, alcohol, idiopathic, pregnancy, Cushing disease) ON of the hip | 51 hips in 40 pts | 5 × 108 MNC | Single center, randomized | ARCO I-II, Mitchell | 3, 6, 12, and 24 mo | Significant improvement in clinical outcome (HHS); significantly better clinical score and mean hip survival with BMNCs), especially in pts with adverse prognostic features at initial presentation | 79 |
| CD and bone marrow concentrate and backfilling Calcium sulfate/calcium phosphate bioceramic | ON of the hip | 37 hips in 31 pts, (24–56 y) | 15-20 cm3 bone marrow concentrate (not further specified) | Single center, single arm | Steinberg I or II or with early segmental collapse, Steinberg IIIa | 12-32 mo | Increase in mean HHS from 68 to 86 points; 78.4% of the hips improved or had no further collapse; overall clinical success rate of 86.5% with three conversions to total hip arthroplasty | 80 |
| CD and autologous bone marrow derived MSCs | Corticosteroid induced ON of the knee | 6 pts (9-21 y), thereof 2 with ALL /NHL, 2 children | 31 × 106 to 240 × 106 MSCs | Single center, single arm | n.s. | Median 16 mo | Reduced pain, ADL improved | 82 |
| CD ± autologous bone marrow–derived MSCs | ONFH and risk factors (trauma, corticosteroids, alcohol, Caisson disease, idiopathic) | 100 pts (18-55 y) | 2 × 106 /kg MSCs | Single center, randomized | ARCO IC-IIC | 6, 12, 24, and 60 mo | 2/53 MSCs treated hips progressed;10/44 hips with CD alone progressed; significant improvement of the HHS and decreased volume of femoral head low signal intensity zone of the hips in the MSC treated group | 76 |
| CD ± autologous bone marrow aspirate concentrate | Nontraumatic femoral head ON | 25 hips in 24 pts (>18 y) | 50.0 ± 15.9 CFUs | Single center, randomized | ARCO II | 12 and 24 mo | No difference between the groups regarding pain and function, head survival rate, and interval to THA | 81 |
| Intervention/cell source . | Indication . | Study cohort . | Cell numbers . | Study design . | Classification . | Follow-up . | Outcome . | Reference . |
|---|---|---|---|---|---|---|---|---|
| CD and volume-reduced autologous bone marrow mononuclear cells | ON (steroids, alcohol, sickle cell disease) of the hip | 534 hips in 342 pts (16-61 y) | Average 24 × 103 CFUs | Single center, single arm | Steinberg stage I-II | 8-18 y | Stage I and II: total hip replacement 94/534 hips | 72 |
| CD ± bone marrow cells | Nontraumatic ON of the hip | 24 hips in 19 pts | CFU-F 92.6 ± 22.4 × 107/cells | Single center, randomized, blinded | ARCO I-II | 60 mo | Significant difference in the time to failure between CD alone and CD with bone marrow cells; significant reduction in pain and joint symptoms and reduced incidence of fractural stages in pts with CD with bone marrow cell implantation | 75 |
| CD ± autologous bone marrow mononuclear cells | Traumatic/nontraumatic (steroids, alcohol, idiopathic, pregnancy, Cushing disease) ON of the hip | 51 hips in 40 pts | 5 × 108 MNC | Single center, randomized | ARCO I-II, Mitchell | 3, 6, 12, and 24 mo | Significant improvement in clinical outcome (HHS); significantly better clinical score and mean hip survival with BMNCs), especially in pts with adverse prognostic features at initial presentation | 79 |
| CD and bone marrow concentrate and backfilling Calcium sulfate/calcium phosphate bioceramic | ON of the hip | 37 hips in 31 pts, (24–56 y) | 15-20 cm3 bone marrow concentrate (not further specified) | Single center, single arm | Steinberg I or II or with early segmental collapse, Steinberg IIIa | 12-32 mo | Increase in mean HHS from 68 to 86 points; 78.4% of the hips improved or had no further collapse; overall clinical success rate of 86.5% with three conversions to total hip arthroplasty | 80 |
| CD and autologous bone marrow derived MSCs | Corticosteroid induced ON of the knee | 6 pts (9-21 y), thereof 2 with ALL /NHL, 2 children | 31 × 106 to 240 × 106 MSCs | Single center, single arm | n.s. | Median 16 mo | Reduced pain, ADL improved | 82 |
| CD ± autologous bone marrow–derived MSCs | ONFH and risk factors (trauma, corticosteroids, alcohol, Caisson disease, idiopathic) | 100 pts (18-55 y) | 2 × 106 /kg MSCs | Single center, randomized | ARCO IC-IIC | 6, 12, 24, and 60 mo | 2/53 MSCs treated hips progressed;10/44 hips with CD alone progressed; significant improvement of the HHS and decreased volume of femoral head low signal intensity zone of the hips in the MSC treated group | 76 |
| CD ± autologous bone marrow aspirate concentrate | Nontraumatic femoral head ON | 25 hips in 24 pts (>18 y) | 50.0 ± 15.9 CFUs | Single center, randomized | ARCO II | 12 and 24 mo | No difference between the groups regarding pain and function, head survival rate, and interval to THA | 81 |
BMNCs, bone marrow mononuclear cells; CD, core decompression; CFU, colony-forming units; HHS, Harris Hip Score; n.s., not specified; ONFH, osteonecrosis of the femoral head; pts, patients.