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Table 2 Outcome assessments experimental phase A

From: Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial

Study period
 Enrollment TreatmentFollow-up
Timepoints  023 days1 week2 weeks3 weeks6 weeks8 weeks10 weeks3 months6 months12 months
Inf. sheetX              
Incl/excl Criteria X             
IC X             
Preop + serology  X            
Allocation   X           
ClinicalHistoryXX             
Physical examXX    XXXXXXXXX
VAS X    XXXXXXXXX
VISA-P X    XXXXXXXXX
blood test            X  
Group MSV
BM
    X          
Group MSV
saline sol.
    X          
Group MSV
MSV
     X         
Group PRP BM sham    X          
Group PRP
PRP
    XX         
Bloodbank    X          
MRI X          X* X
Ultrasound X    XXXXXXXXX
UTC  X     X X XXX
DYN  X     X X XXX
AE    XXXXXXXXXXX
Medication    XXXXXXXXXXX
  1. Elig. eligibility, IC informed consent; VAS visual analogue scale; VISA-P Victorian Institute of Sport Assessment (Patellar); BM bone marrow harvest; MSC Infusion of MSC; MRI magnetic Rresonance; UTC ultrasound tissue characterisation; DYN dynamometry, PreOp preoperative study, AE Adverse Events.
  2. X* if the VAS and VISA-P scales show a significant improvement, and MRI, US, and UTC provide evidence of healing, the result will be considered positive and the patient will be followed up with confirmation controls at 6 and 12 months. For safety reasons, according to AEMPS criteria, a control test will be performed after the trial, within a period of 2 years after treatment.
  3. If the 6-month evaluation shows negative results, patients may be transferred to the open experimental phase B.