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

From: 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

Study period
 Enrollment/AllocationPost-allocationFollow-upClose-out
TimepointD0D0–D30W3a, W6a, W9a, W12aW24aW32a, W40aW52a
Enrollment
 Clinical evaluationX     
 Eligibility screenX     
 AllocationX     
 MRI scan Xb X X
Interventions
 Injection of UA-ADRCs X    
 Injection of corticosteroid X    
Assessments
 A, G, BH, BW, O, LX     
 Safety XXXXX
 ASESX XXXX
 RAND Short Form-36X XXXX
 PainX XXXX
  1. 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
  2. aWeek after treatment
  3. bThe baseline MRI scan of one subject was performed 36 days before screening