Combination Treatment of Biomechanical Support and Targeted Intra-arterial Infusion of Peripheral Blood Stem Cells Mobilized by Granulocyte-Colony Stimulating Factor for the Osteonecrosis of the Femoral Head: A Randomized Controlled Clinical Trial

Abstract

Objective To determine the benefits of combination treatment with mechanical support and targeted intra-arterial infusion of peripheral blood stem cells (PBSCs) mobilized by granulocyte-colony stimulating factor (G-CSF) via the medial circumflex femoral artery on the progression of osteonecrosis of the femoral head (ONFH). Methods 55 patients (89 hips) with early and intermediate stage ONFH were recruited and randomly assigned to combination treatment or mechanical support treatment (control group). All hips received mechanical support treatment (porous tantalum rod implantation). Then, Hips in the combination treatment group were performed targeted intra-arterial infusion of PBSCs. At each follow-up, Harris hip score (HHS) and Association Research Circulation Osseous classification (ARCO) were used to evaluate the symptoms and progression of osteonecrosis. Total hip arthroplasty (THA) was assessed as an endpoint at each follow-up. Results At 36 months, 9 of the 41 hips (21.95%) in the control group progressed to clinical failure and underwent THA whereas only 3 of the 48 hips (6.25%) in the combination treatment group required THA(p=0.031). Kaplan-Meier survival analysis showed a significant difference in the survival time between the two groups (Log-rank test; p=0.025). Compared to the control group, combination treatment significantly improved the HHS at 36 months (p=0.003). At the final follow-up examination, radiological progression was noted in 13 of 41 hips (31.71%) for the control group, while only in 4 of 48 hips (8.33%) for the combination treatment group (p=0.005). The overall collapse rates were 15.15% (5 of 33 hips) and 8.11% (3 of 37 hips) in the control and combination treatment groups, respectively. Conclusions Targeted intra-arterial infusion of PBSCs is capable of enhancing the efficacy of biomechanical support in the treatment of ONFH. This clinical trial confirmed that the combination treatment might be a safe and feasible choice for the treatment of early or intermediate stages of ONFH.

Rehabilitation Program after Cell Therapy for Treatment of Femoral Head Osteonecrosis: A Narrative Review of Literature

“…Treatment using cell therapy was performed in combination with CD surgery [4,[6][7][8][9][10][11][12][13][14][15] or debridement of necrotic bone surgery [15][16][17][18][19][20][21] (Table 1). Bone marrow-derived mononuclear cells (BM-MNCs) [4,[6][7][8][9][10][11][12][13][16][17][18][19][20] and cultured mesenchymal stromal cells (MSCs) [14,15,21] were used for the cell transplantation (Table 1). When debridement surgery is performed, some scaffolds, such as hydroxyapatite, cancellous bone chips, and beta tricalcium phosphate, are transplanted together [15][16][17][18][19][20][21].…”

“…Several patterns of weighting period exist in this stage. In the early bearing group, the start of FWB was allowed 2 weeks [6], 3 weeks [13], and 4 weeks [10,14] after surgery. In the late bearing group, FWB was allowed 8 weeks [20] or 3 months [11] after surgery.…”

“…Although the quiet timing of FWB is unknown, the PWB timing was 6 weeks [9,12]. The collapse rates of the early bearing group (11.9% [6], 0% [13], 13.3% [14]) are lower than those of the late bearing type (19.3% [20], 43.6% [10], 72% [9], and 73.5% [12]). …”

“…In CD surgery, the invasion to muscle structure is relatively low [4,5]. After surgery, the patients are placed on bed rest with skin traction [8,10]. Muscle strength exercises mainly prevent disuse syndrome [8,10,15].…”

“…After surgery, the patients are placed on bed rest with skin traction [8,10]. Muscle strength exercises mainly prevent disuse syndrome [8,10,15]. Water resistance exercises enable coxofemoral joint movement, strengthen the gluteus and quadriceps muscles, and prevent tendon and muscular retractions or harmful postural changes [15].…”