Treatment of osteonecrosis of the femoral head by core decompression and implantation of fully functional ex vivo-expanded bone marrow-derived mesenchymal stem cells: a proof-of-concept study

Figures & data

Table 1 Clinical characteristics of the study population

Patient ID	Age (years)	Gender	AVN feature: side	Ficat class	Comorbidities
#1	23	Male	Left	3	No
#2	44	Female	Left	2	Lupus erythematosus
#3	59	Male	Right	2	Hypertension, hypothyroidism
#4	43	Male	Right	2	Insulin resistance
#5	37	Male	Left	2	No

Abbreviation: AVN, avascular necrosis.

Figure 1 Intraoperative radioscopic views of (A) passing of the 10 mm cannulated drill to the center of the necrotic area in both planes (AP and axial view), (B) the infusion of ex vivo-expanded autologous MSCs into the necrotic area and (C) the subsequent syringe filling of the drilling canal. In all cases, the guide wire was stopped at the subchondral bone of the necrotic area.

Abbreviation: AP, anteroposterior.

Figure 2 X-ray and/or MRI images of the pelvis of an AVN patient (#3) at inclusion in the study (A, B, C), immediately after the cell infusion (D) and after a 3-year followup period (E).

Abbreviation: AVN, avascular necrosis; MRI, magnetic resonance imaging.

Table 2 Assessment of phenotypical and functional attributes of ex vivo-expanded bone marrow-derived MSCs

Patient ID	Expansion cyclesa	Fulfillment of “minimal phenotypical” markersb	Functional markersc
			CPD	FFS
#1	2	Yes	1.2/1.2	92/94
#2	3	Yes	1.5/1.5	93/95
#3	2	Yes	1.8/1.7	92/95
#4	3	Yes	1.6/1.5	93/95
#5	2	Yes	1.4/1.4	92/94

Notes:

a Required to manufacture the cell product.

b Dominici et al.¹⁸

c As assessed²⁰ at the end of the first and last ex vivo expansion cycle.

Abbreviations: CPD, cumulative population doubling; FFS, fast forward scatter.

Table 3 Patients’ clinical outcome after instillation of the ex vivo-expanded autologous MSC-based product

Patient ID	Time elapsed from cell infusion (months)	Modified Harris hip score		Visual analog scale
		Before	After	Before	After
#1	50	90	100	6	0
#2	36	95	100	3	0
#3	37	71	96	5	0
#4	31	65	100	4	1
#5	15	47	95	5	1

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