Table 2.

Outcome assessments experimental phase A

Study period
	Enrollment				Treatment		Follow-up
Timepoints					0	23 days	1 week	2 weeks	3 weeks	6 weeks	8 weeks	10 weeks	3 months	6 months	12 months
Inf. sheet	X
Incl/excl Criteria		X
IC		X
Preop + serology			X
Allocation				X
ClinicalHistory	X	X
Physical exam	X	X					X	X	X	X	X	X	X	X	X
VAS		X					X	X	X	X	X	X	X	X	X
VISA-P		X					X	X	X	X	X	X	X	X	X
blood test													X
Group MSV BM					X
Group MSV saline sol.					X
Group MSV MSV						X
Group PRP BM sham					X
Group PRP PRP					X	X
Bloodbank					X
MRI		X											X*		X
Ultrasound		X					X	X	X	X	X	X	X	X	X
UTC			X						X		X		X	X	X
DYN			X						X		X		X	X	X
AE					X	X	X	X	X	X	X	X	X	X	X
Medication					X	X	X	X	X	X	X	X	X	X	X

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.

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.

If the 6-month evaluation shows negative results, patients may be transferred to the open experimental phase B.