Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study

Table 1 Schedule of enrollment, interventions, and assessments during this pilot study according to SPIRIT [32]

Study period
	Enrollment/Allocation	Post-allocation	Follow-up			Close-out
Timepoint	D0	D0–D30	W3^a, W6^a, W9^a, W12^a	W24^a	W32^a, W40^a	W52^a
Enrollment
Clinical evaluation	X
Eligibility screen	X
Allocation	X
MRI scan		X^b		X		X
Interventions
Injection of UA-ADRCs		X
Injection of corticosteroid		X
Assessments
A, G, BH, BW, O, L	X
Safety		X	X	X	X	X
ASES	X		X	X	X	X
RAND Short Form-36	X		X	X	X	X
Pain	X		X	X	X	X

D day; W week; UA-ADRCs fresh, uncultured, unmodified, autologous adipose derived regenerative cells; A age; G gender; BH body height; BW body weight; O occupation; L leisure activities
^aWeek after treatment
^bThe baseline MRI scan of one subject was performed 36 days before screening

ISSN: 1749-799X